Tumor Microenvironment Antibody, Parallel Cell Line Development till GMP Manufacturing

Berlin, Germany, March 08, 2018 / B3C newswire / -- ProBioGen AG, a premier German service & technology provider for complex therapeutic glycoproteins announced signing the second antibody development project with Cambridge, MA-based Surface Oncology Inc., an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment.

Under the terms of the agreement Surface Oncology will contract with ProBioGen to develop and manufacture another antibody for potential use in clinical trials. ProBioGen will develop several stable cell lines in parallel, gradually reduce the candidate number and conclude with process development and GMP manufacturing for a single antibody product candidate. The advantage of this approach is the meticulous analysis of several candidates at the same time while strongly reducing time lines.

ProBioGen’s CBO, Dr Gabriele Schneider commented:“We have worked together with Surface Oncology very well for quite a while and this is now our second potential clinical antibody project together. We have established a seamless team working across our companies and we are very pleased to continue to expand this relationship with Surface Oncology”.

About ProBioGen AG
ProBioGen is a premier, Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development platforms, based on ProBioGen’s CHO.RiGHT® expression and manufacturing platform, together with intelligent product-specific technologies, yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team.
All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen was founded 1994, is privately owned and located in Berlin, Germany.

Contact

Dr Gabriele Schneider
Chief Business Officer
ProBioGen AG
Goethestr. 54
13086 Berlin, Germany
+49 30 924 006-0
cmo@probiogen.de

London, UK, March 09, 2018 / B3C newswire / --Orchard Therapeutics, a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced that one of its scientific founders and scientific advisory board member, professor Donald Kohn, has been recognized with the Pediatric Blood and Marrow Transplant Consortium (PBMTC) Lifetime Achievement Award on Feb. 22, 2018 in Salt Lake City.

The PBMTC Lifetime Achievement Award recognizes outstanding individuals who have made major contributions to the field of pediatric hematopoietic stem cell transplantation. The award highlights and honors the contributions and careers of individuals whose work exemplifies the PBMTC mission statement: “To support research and education to improve the availability, safety, and efficacy of hematopoietic cell transplantation and other cellular therapeutics for children and adolescents.”

Professor Kohn has focused his career on the development of hematopoietic stem cell gene therapy for immunodeficiencies, hemoglobinopathies and inborn errors of metabolism. His work includes the development of tools for efficient gene addition or correction, and persistent transgene expression, for the amelioration of genetic disease.

A formal presentation of the award was followed by a presentation of key achievements in professor Kohn’s research.  Professor Kohn described the 30-year journey developing ADA-SCID gene therapy, recognizing the contributions of many in the field, leading to the development of Orchard’s lead product, OTL-101, for the treatment of ADA-SCID.

Professor Kohn commented,“I am deeply honored to be recognized by the Pediatric Blood and Marrow Transplant Consortium with their Lifetime Achievement Award and look forward to continuing the development of transformative treatments for patients with severe and life-threatening diseases.”

Professor Bobby Gaspar, chief scientific officer of Orchard said,“This prestigious award recognizes the pioneering work of professor Kohn in advancing cutting-edge research for hematopoietic stem cell gene therapy. At Orchard, we are honored to collaborate with professor Kohn and UCLA to bring transformative treatments to patients across the world. Dr. Kohn’s dedication to patients, humility and team spirit are an inspiration for us all”.

 
About Orchard Therapeutics
Orchard Therapeutics is a privately held clinical-stage biotechnology company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard, based in the UK and US, has partnered with world leading institutions in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles and Boston Children’s Hospital. Orchard’s growing pipeline of autologous ex vivo lentiviral gene therapy programs for rare immune deficiencies and metabolic disorders includes late clinical stage programs that have already demonstrated the transformative power of gene therapy on patients’ lives. In 2016 the company was named a Fierce 15 Company by Fierce Biotech and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM) to advance their autologous ex vivo lentiviral gene therapy in ADA-SCID. In 2017, Orchard raised $110 million in a Series B round of funding to further develop its pipeline in parallel with enhancing manufacturing capabilities.

Contacts

Corporate contact
Nicolas Koebel
Orchard Therapeutics
+44 (0) 203 384 6700
Nicolas.koebel@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

• Unique, single-use perfusion system offers a fast-track to intensified cell culture process development
• Product innovation being unveiled at BPI West Conference, San Francisco, USA

Goettingen, Germany, March 14, 2018 / B3C newswire / --Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry today announced the launch of the ambr® 250 high throughput (ht) perfusion, a new automated parallel bioreactor system. It has been specially designed for rapid cell culture perfusion process development to optimize production of therapeutic antibodies. The system will be launched at the BPI West 2018 Conference in San Francisco, USA (19-22 March, 2018).

The ambr 250ht perfusion system has been developed in collaboration with major biopharma companies. It combines 12 or 24 single-use perfusion mini bioreactors (100-250 mL working volume) with associated single-use perfusion components, all controlled by one automated workstation. The combination of this multi-parallel processing capacity and fully single-use perfusion vessel enables scientists to perform more perfusion culture experiments in a fraction of the time and cost of using traditional perfusion-enabled bench top bioreactors. This new innovation supports a range of hollow fiber perfusion applications, enabling Design of Experiments (DoE) studies for high cell density process development in a Quality by Design (QbD) approach.

Central to the system is the novel perfusion bioreactor assembly, which is based on the established and award-winning ambr® 250 bioreactor design. Intensified cell culture processing is enabled via new components such as high efficiency spargers, perfusion pump chambers and an industry standard hollow fibre for cell retention filter. The geometrical similarity of the mini perfusion bioreactor design to BIOSTAT STR® pilot and manufacturing scale bioreactors, enables rapid scale-up of optimized perfusion processes, and shorter development timelines.

The ambr 250ht perfusion system is simple to set up and use, due to the fully assembled and irradiated perfusion bioreactors which include all the essential components. This includes single-use sensors to continuously monitor pressure at the culture fluid inlet and permeate outlet, enabling online monitoring of transmembrane pressure, as well as standard parameters such as pH and DO.

Dr Barney Zoro, ambr Product Manager at Sartorius Stedim Biotech, explains:“By introducing our new ambr 250ht perfusion system, we are offering our customers an important enabling technology for early-stage development of intensified cell culture processes. Transitioning from fed-batch to perfusion culture offers the potential to reduce capital intensive risk by using 1-2000L single-use bioreactors instead of 10,000L production volumes in stainless steel. ambr 250ht perfusion is a predictive process development tool that could lower the cost of goods of antibody production, as well as significantly shortening development timelines.”

Sartorius Stedim Biotech looks forward to welcoming bioprocess scientists to Stand 407 at BPI West where they can find out how utilizing this single-use perfusion platform will deliver a step-change in their scalable bioprocess development.

To find out more about SSB’s new ambr 250ht perfusion system, please click for more details:https://www.sartorius.com/sartorius/en/EUR/products/bioreactors-fermentors/multi-parallel-bioreactors/ambr_perfusion

Image Files

Caption: The ambr 250ht perfusion system has been specially designed for rapid cell culture perfusion process development to optimize production of therapeutic antibodies.
For high resolution please click the image.

SSB new ambr 250 high throughput perfusion system photo 1
SSB new ambr 250 high throughput perfusion system photo 2

Video File
https://sartorius.wistia.com/medias/5a446hh1c5

 
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2017, the company employed approx. 5,100 people, and earned sales revenue of 1,081 million euros.

ambr® systems are designed and manufactured by Sartorius Stedim Biotech/TAP (Royston UK), specialized for automated cell culture and fermentation systems for life science research, development and production. The ambr® systems are widely used for cell line development and process optimization at pharmaceutical, biotechnology and academic laboratories. They are proven to provide a reliable model and consistent scalability to a range of upstream processes.

Contact

Dominic Grone
Senior Manager Corporate Communications
Sartorius Corporate Administration GmbH
+49.(0)551.308.3324
dominic.grone@sartorius.com
www.sartorius-stedim.com

Goettingen, Germany, March 16, 2018 / B3C newswire / --Sartorius Stedim Biotech S.A. (SSB), a leading international technology partner of the biopharmaceutical industry, has been selected by ABL Europe as its primary supplier of single-use systems. Through a supply partnership with SSB, ABL Europe has successfully increased and brought online new viral vector manufacturing capacity at its European facility in Strasbourg. A subsidiary of ABL Inc., ABL Europe provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.

Sartorius Stedim Biotech has delivered a comprehensive GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration and mixing. These have been installed at the facility, which is now in the process of manufacturing batches of viral vector products for ABL’s clients. Sartorius Stedim Biotech’s end-to-end process solutions in single-use (SU) format have helped ABL expand its existing drug substance capacity, with a fully disposable manufacturing capability for different viral vector product types produced in non-adherent cell lines.

Amélie Boulais Raveneau, Vaccine Platform Marketing Manager at SSB, commented:“We’re very proud to have been selected by ABL Europe to supply single-use process technologies and analytics specifically designed for use throughout ABL’s viral vector manufacturing process train. It is a significant endorsement of SSB’s platform for viral vector processing and the single-use design capabilities of the Sartorius Integrated Solutions engineering team. Our process development consultants share their expertise with clients to ensure optimal implementation of our technologies and overcome challenges in viral vector applications.”

Patrick Mahieux, General Manager of ABL Europe, has considerable experience in virus manufacturing including senior positions at Sanofi, Guerbet and Transgene. He said,“The introduction of non-adherent cell culture capacity complements our existing adherent cell culture viral vector production technologies. It is the only pure-play, dedicated viral vector production site capable of manufacturing drug substance and drug product materials for toxicological studies, all clinical phases and even commercial launch. Everything from process development, manufacturing and QC release testing is performed under one roof.”

To learn more about the facility, visit: https://vimeo.com/246296559

 
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2017, the company employed approx. 5,100 people, and earned sales revenue of €1,081.0 million.

About ABL Europe
ABL Europe, a subsidiary of ABL, Inc. under the corporate ownership of Institut Mérieux, offers clinical and commercial scale GMP manufacturing of viral vectors for supply of gene therapy, oncolytic and vaccine products for use in all stages of product development globally. From its state-of-the-art GMP facility located in Strasbourg, France, ABL Europe's aseptic processing capabilities for drug substance and drug product, includes stirred single use bioreactors (SUB) < 500 L, adherent capacity in roller bottles or cell stacks < 90 m², and automated filling using a rigid isolator < 10,000 vials per batch. ABL Europe is collaborating with an expanding client base supporting projects in phase 1/2 development, in addition to providing process validation and product supply for phase 3 / pivotal efficacy studies.

 
Contacts

Sartorius Stedim Biotech
Petra Kirchhoff
Vice President of Corporate Communications
+49(0)551.308.1686
petra.kirchhoff@sartorius.com
www.sartorius-stedim.com

ABL Europe
contact@ableurope.com

London, UK, March 21, 2018 / B3C newswire / --Orchard Therapeutics, a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced two key additions to its executive leadership team, appointing Jason Meyenburg as chief commercial officer and John Ilett as general counsel & company secretary.

Mark Rothera, Orchard’s CEO, stated:“I am delighted to welcome Jason and John to Orchard’s executive leadership team. We are making great strides toward building a leading, global, fully-integrated company bringing transformative gene therapies to patients. Both Jason and John’s skills and experience will be essential in delivering Orchard’s vision, especially as we prepare for potential commercialization of our lead program as early as 2019.”

Chief commercial officer Jason Meyenburg brings extensive global commercialization experience to Orchard including the launch of multiple therapies for ultra-rare life-threatening diseases, new market entry strategies, market access and organizational development. He joins the company to lead the global commercialization of gene therapies for primary immune deficiencies and inherited metabolic disorders. Orchard anticipates submitting a biological license application for its lead program OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency) in 2018.

Until recently, Meyenburg served as chief commercial officer at Sucampo Pharmaceuticals, Inc. and Vtesse. Mr. Meyenburg also led commercial operations at Alexion in the U.S. and Latin America in the hematology, nephrology and metabolic business units, and held commercial leadership roles expanding access to the company's products in Europe, the Middle-East, Africa and Japan. Mr. Meyenburg holds a Bachelor of Science in Biochemistry from the University of Maryland and a Master of Business Administration from Duke University's Fuqua School of Business.

Mr. Meyenburg commented: "I am thrilled to be joining a stellar leadership team at Orchard to advance the commercialization of gene therapies for patients with rare and life-limiting diseases around the world.”

General counsel and company secretary John Ilett brings broad expertise in corporate, commercial and IP law. He has extensive experience in legal, compliance and corporate secretarial roles in international biopharmaceutical and life sciences companies. He also brings commercial and biotech intellectual property experience. He joins Orchard to lead the company’s legal function.

Prior to joining Orchard, Mr. Ilett was a non-executive director at Oxular Limited and group general counsel & company secretary at Consort Medical plc. He held senior legal affairs roles at several companies operating in the rare disease space including Synageva, BioMarin and Oxford GlycoSciences.

Mr. Ilett is a qualified solicitor. He received his Bachelor of Law degree in Business Law from City of London, his postgraduate diploma in EC Competition Law from King's College, London and a postgraduate diploma in Intellectual Property Law from Queen Mary University of London.

Mr. Ilett commented:“This is an exciting time to be joining Orchard with its advanced pipeline in gene therapy. Through my prior roles, I have developed a deep passion for the orphan disease sector and look forward to contributing toward the development of life transforming gene therapies.”

 
About Orchard Therapeutics
Orchard Therapeutics is a privately held clinical-stage biotechnology company dedicated to transforming the lives of patients with rare and life-threatening diseases by developing innovative gene therapies. Orchard, based in the UK and US, with a presence in London, San Francisco and Boston, has partnered with world leaders in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles and Boston Children’s Hospital. Orchard’s growing pipeline of autologous ex vivo lentiviral gene therapy programs for rare immune deficiencies and metabolic disorders includes late clinical stage programs that have already provided transformative treatment for patients with rare genetic diseases. In 2016 the company was named a Fierce 15 Company by Fierce Biotech and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM) to advance their autologous ex vivo lentiviral gene therapy in ADA-SCID. In 2017, Orchard raised $110 million in a Series B round of funding to further develop its pipeline in parallel with enhancing manufacturing capabilities.

Contacts

Corporate contact
Mary D. Wallace
Orchard Therapeutics
781-608-3666
Mary.Wallace@orchard-tx.com

Media contact
Allison Blum, Ph.D.
LifeSci Public Relations
+1 516 655 0842
Allison@lifescipublicrelations.com

Irvine, CA, USA, Amsterdam, the Netherlands, March 21, 2018 / B3C newswire / -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that its next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit is now CE marked, enabling the Company to commercialize the device in Europe.

Dr. Marjolaine Baldo, Commercial Vice President, EMEA at Agendia said: “Obtaining the CE mark for the MammaPrint BluePrint Kit is a huge milestone. For the first time, prestigious cancer centers across Europe will be able to run MammaPrint and BluePrint in their own labs, using their existing NGS instruments. As a result, patients will have better access to these vital tests and the significant benefits that they bring in personalizing breast cancer management.

“We are proud of the drive, dedication and expertise of our team, partners and co-validation centers who, in recognizing the need for a decentralized solution, have worked tirelessly to develop, validate and deliver this important device to the market.  We look forward to collaborating with leading breast cancer centers to provide them with these tools, enabling them to offer breast cancer risk-of-recurrence testing in-house.”

MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary Low or High Risk of cancer recurrence result, while BluePrint analyzes 80-genes which classify a patient’s breast cancer into functional molecular subtypes. This new device, which combines both MammaPrint and BluePrint, can aid physicians in personalizing treatment management decisions for their patients by identifying women with early-stage breast cancer who are at a genomic Low or High Risk for distant metastasis within five years.

The MammaPrint BluePrint Kit is an RNA-sequencing based version of Agendia’s existing MammaPrint and BluePrint tests, which are currently performed centrally at the Company’s CLIA-certified and CAP-accredited laboratories in Irvine, CA and Amsterdam, the Netherlands. The Kit was developed in partnership with Agilent Technologies using their SureSelect target enrichment system and with Bluebee, who provided the secure and convenient data processing solution for clinicians.

Dr. William Audeh, Chief Medical Officer at Agendia, said: “The clinical utility of the MammaPrint test has been demonstrated by the landmark MINDACT trial. It showed, with the highest level of clinical evidence, that 46% of patients identified as high risk for recurrence according to clinical-pathological factors and who would therefore be typical candidates for adjuvant chemotherapy were reclassified as Low Risk by MammaPrint, indicating that they were unlikely to benefit from chemotherapy.(1)

“With breast cancer being the most common cancer in women, affecting one in eight in Europe and with almost 500,000 new cases a year, the quality-of-life and cost benefits of identifying women previously selected for chemotherapy that may not have significant benefit from it is considerable.”(2,3)

To learn more about the MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, visit: www.agendia.com/diagnostic-products (Europe only)

About MammaPrint®
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union.  The MammaPrint® BluePrint® next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.

MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.

About MINDACT
MINDACT is a prospective, randomized, phase III, controlled clinical trial that investigated the clinical utility of MammaPrint, when used in conjunction with standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy. From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer were enrolled in the trial, across 112 centers in nine countries.

About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test, both on microarray technology, and the new MammaPrint BluePrint Recurrence and Molecular Subtyping test, on NGS technology.

In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.

For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.  

Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

Contacts

Instinctif Partners (Agendia)
Ashley Tapp / Lynne Trowbridge / Samantha Cheung      
+44 (0) 20 7866 7923
agendia@instinctif.com                                                               

Léon Melens (Netherlands media)
+31 (0) 6 538 16 427
lmelens@lifescpring.nl

(1) Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
(2) Curado MP, et al. Cancer Incidence in Five Continents, Vol. IX, IARC Scientific Publications No. 160. IARCPress: Lyon: 2007.
(3) Ferlay J, et al.e. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 (Internet). Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed 04 August 2017

The CDMO is honored with an international industry prize

• Center for Visual Inspection and Logistics awarded in the category Facility of the Future
• Expert jury rewards intelligent combination of location design, state-of-the-art technologies and innovative processes
• Customers benefit from optimized and highly efficient supply chain processes

Ravensburg, Germany, March 21, 2018 / B3C newswire / -- Vetter has won the 2018 ISPE Facility of the Year Award (FOYA) in the Facility of the Future category for its Center for Visual Inspection and Logistics. The renowned prize is awarded annually by the prominent industry association, the International Society for Pharmaceutical Engineering (ISPE), to companies that have shown outstanding foresight, care and innovative creativity in the design and implementation of their facilities. The FOYA judges panel for ISPE was impressed by the intelligent combination of location design, state-of-the-art technologies and innovative processes at the Ravensburg Vetter West site. The new center offers an outstanding degree of efficiency, flexibility, quality and security in the injectables supply chain. For more information on ISPE and the FOYA Awards program go to:  https://www.ispe.org/facility-year-awards.

Altogether, the site offers Vetter's customers a great deal of added value, notably most outstanding quality with reduced throughput times, irrespective of the batch size. The building‘s modular design also allows for simple and gradual creation of more space without expansion work affecting its operations. This architecture is a direct response to an increasing customer demand for more capacity.

“We are very pleased to have received this important international award,” said Vetter Managing Director Thomas Otto.“Being selected by the jury is not only a great honor, but also an incentive to maintain our focus on quality in terms of products and processes.” His management colleague Peter Soelkner summarizes:“In our future-oriented Center for Visual Inspection and Logistics, we combine many years of expertise in optimizing supply chain processes. In this way, we can offer our customers – including the world's top 20 pharmaceutical and biotech companies – ideal conditions for transport, storage and quality assurance of their products.”

CMO Leadership Awards 2018
Vetter, the global pharmaceutical service provider, was also honored recently with the CMO Leadership Awards 2018 in no less than five of the six main categories – quality, expertise, reliability, capabilities and service. Life Science Leader, one of the leading trade journals in the pharmaceutical industry, awarded the prize for the seventh time. The magazine worked with the market research institute Industry Standard Research (ISR) to identify the winners. It is important to note that the winners do not need to apply, as is the case with other awards. Rather, it is the customers who evaluate their experience in working with manufacturing partners. Respondents only rate companies with which they have worked on a specific project over the past 18 months. This guarantees real empirical data from surveys of pharmaceutical companies that evaluate their experience in working with manufacturing partners.

Caption: The award-winning “Facility of the Future” Ravensburg Vetter West: Vetter’s Center for Visual Inspection and Logistics.
Source: Vetter Pharma International GmbH
For high resolution please click the image.

Caption: FOYA Logo
For high resolution please click the image.

Find the Vetter press kit, additional press releases, high-resolution pictures and more background information in our Download Center.

About Vetter
Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany and the United States. The company has long-term experience offering services ranging from early development support including clinical manufacturing, to commercial supply and various packaging solutions for vials, syringes and cartridges. Vetter’s customers range from small and midsize to the world’s top 20 pharmaceutical and biotech companies. As a leading solution provider, the CDMO recognizes its responsibility in supporting the needs of its customers in developing devices that contribute to increased patient safety, convenience, and enhanced compliance.

 
Contact

Vetter Pharma International GmbH
Markus Kirchner
Corporate Spokesperson / Media Relations
Eywiesenstrasse 5
88212 Ravensburg
Germany
+49 (0)751-3700-3729
PRnews@vetter-pharma.com

Official opening with event on the future of regenerative medicine later in 2018

Waalre, The Netherlands, March 23, 2018 / B3C newswire / -- Medical technology company IME Technologies, developer, producer and scientific partner in the field of biomedical electro spinning processes and equipment, has moved its operations from Geldrop to a significantly larger facility in Waalre with effect from 26 March. IME's state-of-the-art technology enables scientists to develop medical implants that help the human body to repair itself, such as heart valves, blood vessels, nerves, tendons, skin and bone. IME is a world leader in this field. Later this year (September 2018) IME Technologies will officially open the new facility during an event themed 'The future of regenerative medicine'.

In the new IME building at the Van Dijklaan in Waalre, the company will have the ability to, according to the highest standards, not only produce its electro spinning machines autonomously, but also the actual extracellular matrices or scaffolds for the intended medical implants. These are developed by IME in close collaboration with various partners. The company has a growing number of customers and partners worldwide in industry, science and medical institutes.

IME's technological solutions are able to mimic the natural human extracellular matrix for implants in the human body in nanometer format, applying specific polymers. Human cells attach to this matrix leading to new body tissue. This is in contrast to implants of traditional structures, which are seen as foreign and therefore can be rejected or lead to scar tissue.

New address
IME Technologies
Van Dijklaan 6
5581 WG Waalre
The Netherlands
+31 40 28 27 956
www.imetechnologies.com

 
About IME Technologies
IME Technologies develops and implements electro spin processes and equipment for the manufacturing of medical devices for (regenerative) medicine. Electro spinning is a flexible process for producing extremely thin fibres and structures that have excellent properties for use in regenerating human tissue. IME Technologies has developed unique electro spin technology for the reproducible and scalable production of electro spun material under medical conditions. Customers include industry, scientists and institutions.

Shareholders in the company are Dutch economic development company De Brabantse Ontwikkelings Maatschappij (BOM) and informal investor network TIIN Capital (TIIN).

 
Contacts

IME Technologies, Waalre, The Netherlands
Judith Heikoop M.Sc. Ph.D.
+31 (0)40 – 28 27 956
j.heikoop@ imetechnologies.nl

LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Léon Melens
+31 (0)6 – 538 16 427
lmelens@lifelspring.nl

Further demonstrate the test’s ability to impact treatment decisions with an overall reduction in chemotherapy use and underscore the value of broader access for patients

Geneva, Switzerland, March 23, 2018 / B3C newswire / --Genomic Health today announced the presentation of new data with the Oncotype DX® test at the 11th European Breast Cancer Conference (EBCC-11) in Barcelona, Spain.

The presentations underline the substantial real-world evidence available for Oncotype DX and reflect the growing adoption of the test across Europe to personalize and improve the quality of clinical decisions, leading to better patient outcomes and more cost-effective treatment.

Data highlights include:

• A study(1) which assessed the impact of the test on treatment decisions in patients from 27 centers across five Italian regions. A total of 1,738 patient cases collected between March 2016 and December 2017, including both lymph node negative and lymph node positive breast cancer, were analyzed. Results from this real-life clinical practice survey showed that 49% of those patients who were prescribed chemotherapy before testing were spared such treatment based on their Recurrence Score® result, while 12% of patients who were assigned to hormone therapy alone had chemotherapy added to their treatment plan after testing.
  
  These results are consistent with other international studies utilizing Oncotype DX and further demonstrate the clinical utility of the test and its impact in terms of potential savings to the healthcare system.

• A decision impact study(2) with 110 patients from France which demonstrated that testing with the Breast Recurrence Score™ reduced the use of chemotherapy by 56.4%. More importantly, the study compared treatment decisions between different tumor boards before testing with the Oncotype DX test and showed a low level of concordance based on 20 randomly-selected cases.
  
  These findings are consistent with those of a survey conducted between August 2013 and January 2014 and recently published(3) that indicates significant heterogeneity in how early breast cancer patients are treated and substantial uncertainty in treatment recommendations for a large proportion of patients, thus highlighting the need for better evidence to inform treatment decisions and greater consistency in clinical practice. This is where a multigene test such as Oncotype DX, which is the only test available that is validated to accurately identify patients who are most likely to benefit from adjuvant chemotherapy, can play a key role in creating a recognized standard of clinical excellence in clinicians’ recommendations for breast cancer treatment.

• A sub-analysis(4) from a study done in France which looked at the test utilization in real-life clinical practice in 126 patients with lobular breast cancer. The findings indicate that testing with Oncotype DX resulted in a 47% change in treatment decisions, leading to a 36% net reduction in chemotherapy use.

“These studies are very important and confirm the value of the test to standardize therapeutic strategies in hormone-sensitive breast cancer and to avoid, without risk, adjuvant chemotherapy in nearly 40% of women initially considered candidates for such treatment based on traditional criteria,”said Prof David Khayat, Head of Medical Oncology at Clinique Bizet, Paris; Founder and former President of the French National Cancer Institute.

 
About early-stage breast cancer and the Oncotype DX test
Oncotype DX is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Breast cancer is the most common cancer in European women(5) and affects many of them during their years dedicated to working and raising a family. While chemotherapy is routinely offered, research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from it.(6)

The Oncotype DX test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems. This is supported by substantial real-world evidence showing that the test can reduce the number of women undergoing unnecessary chemotherapy by up to 60 percent.(7)

Healthcare systems across Europe are recognizing the value of the test, which is incorporated in all major international clinical guidelines. Following assessment and recommendation by NICE, the Oncotype DX test is widely available to patients across the UK. In France, Oncotype DX is available through a funding mechanism for genomic tests. Other European countries where the test is reimbursed include Switzerland, Ireland, Greece and Spain.

About Genomic Health
Genomic Health, Inc. is the world’s leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company’s flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 850,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect™ test. The company is based in Redwood City, California with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the ability of any potential tests Genomic Health, Inc. may develop to optimize cancer treatment and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's yearly report on Form 10-K for the quarter endedSeptember 30, 2017. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Oncotype IQ, Oncotype DX Breast Recurrence Score, Recurrence Score, and Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. 

Contact

Federico Maiardi
Genomic Health
+41 79 138 1326
fmaiardi@genomichealth.com

(1) Cognetti F., Barni S., PB-166, presented at EBCC-11
(2) Antoine E.C., PB-130, presented at EBCC-11
(3) Aapro M. et al., The MAGIC survey in hormone receptor positive (HR+), HER2-negative (HER2-) breast cancer: When might multigene assays be of value?, The Breast 33 (2017) 191e199
(4) Furtos-Fanget C, PB-165, presented at EBCC-11
(5) EUCAN. 2012. Available at: http://eco.iarc.fr/EUCAN/CancerOne.aspx?Cancer=46&Gender=2
(6) Paik et al. J Clin Oncol. 2006 ; Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) et al. Lancet. 2012.
(7) Loncaster J et al, Eur J Surg Oncol 2017

Lund, Sweden, April 03, 2018 / B3C newswire / --TFS International is delighted to announce that Dr Andrew Copestake has accepted the position of Chief Commercial Officer and Executive Vice President, Global Business Development. Dr Copestake is an entrepreneurial, commercially focused, senior executive with over 25 years’ experience in the pharmaceutical, biotechnology and CRO industry.

His most recent role was with Julius Clinical, a science-driven CRO based in the Netherlands, where he held the position of Chief Business Development Officer.    

Previous roles have included a number of senior leadership positions in business development and general management, including six years as CEO of a Swedish biotechnology company.

“We are delighted to welcome Andrew into our TFS family where he will lead our commercial activities.” said Dr János Filakovský, Chief Executive Officer.“Andrew has truly global experience and brings with him a deep understanding of our Biopharmaceutical Services industry, in combination with outstanding technical and leadership skills.  We are looking forward to him joining to further accelerate our capabilities, service offerings and strengthen our strategic customer relationship strategy.”

The majority of Andrew’s experience has been in international roles and he has lived and worked in the UK, US, Japan, Sweden and the Netherlands. He has managed diverse business development teams, and is proud of his record of achieving growth. Andrew has proven leadership skills with an ability to manage businesses through significant change whilst achieving key operational and financial performance targets.

Andrew said of this new role,“I am very excited to be joining TFS.  As one of the leading mid-sized, global CROs, TFS is well placed to take advantage of the significant growth opportunity in this sector.  As we see many CROs increasing in scale, our customers are failing to experience increasing levels of service, whilst simultaneously facing rising costs, and reduced market choice.  By offering excellent customer experience combined with global capabilities and competitive pricing, TFS can present a truly differentiated service, which will result in significant benefits for clients, patients and employees. It will be my responsibility to help guide TFS through this exciting phase of development and I am grateful to János, the TFS board and the leadership team for offering me this wonderful opportunity.”

Dr Copestake will be based out of the TFS offices in London.

 
About TFS International
TFS International is a leading, mid-size clinical Contract Research Organization providing global clinical development solutions. Founded in 1996 in Sweden, TFS currently operates in 21 countries throughout Europe and North America and employs more than 700 professionals. TFS’ core therapeutic areas of expertise are oncology, dermatology, ophthalmology, immunology, cardiology, CNS and endocrinology. Through two business areas, TFS Develop™ and TFS People™, TFS provides end-to-end solutions and tactical functional services throughout the world.

Contact

TFS International
Andy Waiton, Director – Marketing & Communications
+46 46 280 18 00

Lund, Sweden, April 04, 2018 / B3C newswire / --TFS International, a leading, mid-sized clinical Contract Research Organization (CRO) is dedicated to the innovative use of technology to advance clinical development.

TFS Chief Medical Officer, Dr Bassem Saleh, has announced an agreement with the Pharma Intelligence division of Informa for their industry-leading, global research and development (R&D) platform - Citeline.

“At TFS we are already proud of the strategic and operational services that we provide our biotechnology and pharma clients.” said Dr Saleh. “This agreement with Citeline will take us to the next level and provide the strategy and operational team’s access to global, R&D intelligence platforms on a par with the largest CRO organizations.”

The services provided by Citeline will allow TFS to:-

• Maximize data analytics to create effective study strategies including country/site strategies and enrollment modelling.
• Perform comprehensive Endpoint analysis to recommend robust endpoints for clinical trial design
• Gain access to country specific enrollment benchmarks and patient data to facilitate selection of the best sites and ensure recruitment timelines are met
• Assess target locations and identify and prioritize qualified investigators and sites due to a database of over 400,000

…and much more.

Dr Saleh concludes“Citeline is the industry’s most comprehensive, reliable and current global R&D intelligence suite of solutions. Along with my IT colleagues, we are always looking for the industry-leading technologies to drive TFS forward, and with Citeline we are demonstrating exactly that.”

The importance of this Citeline and other technology investments to TFS was highlighted by Chief Executive Officer, János Filakovský, “We are very excited about our cooperation with Citeline. We will continue to invest in industry leading technologies, and in our people to provide innovative, data-driven productive solutions to our global customers.”

About Citeline
Citeline, part of Informa’s Pharma Intelligence vertical, is the world’s most comprehensive source of real-time R&D intelligence for the pharmaceutical industry, featuring an unmatched intelligence collection and enrichment of global clinical trials, clinical trial investigator profiles and drug development pipelines.

Citeline is the R&D Intelligence arm of Informa’s Pharma Intelligence vertical, one of the world’s leading providers of drug, device, company, clinical trial and market intelligence in the pharma and medtech markets.  For more information, visit pharmaintelligence.informa.com.

About TFS International
TFS International is a leading, mid-size clinical Contract Research Organization providing global clinical development solutions. Founded in 1996 in Sweden, TFS currently operates in 21 countries throughout Europe and North America and employs more than 700 professionals. TFS’ core therapeutic areas of expertise are oncology, dermatology, ophthalmology, immunology, cardiology, CNS and endocrinology. Through two business areas, TFS Develop™ and TFS People™, TFS provides end-to-end solutions and tactical functional services throughout the world.

Contact

TFS International
Andy Waiton, Director – Marketing & Communications
+46 46 280 18 00

Krakow, Poland, April 06, 2018 / B3C newswire / --Selvita (WSE:SLV), a clinical stage drug discovery and development company focused on innovative medicines for oncology patients, will publish the most recent data from its oncology programs at the upcoming AACR Annual Meeting 2018, which will take place on April 14-18 2018, in Chicago, IL, USA.

Data presented at the conference will include recent results from Selvita’s CDK8 inhibitor program, SEL120, developed in cooperation with The Leukemia and Lymphoma Society in the area of acute myeloid leukemia, as well as two discovery phase projects targeting cancer immunometabolism: SHMT2 small molecule inhibitors and dual A2A/A2B adenosine receptor antagonists.

“We are very glad to be able to present new results from our early discovery projects. We see our immunometabolism programs as important and very promising assets in our pipeline. At the same time we are presenting the most recent results from our most advanced fully-owned oncology program – SEL120 – which is on track to start Phase I in 1Q2019” - said Krzysztof Brzozka, Chief Scientific Officer at Selvita.

The results from Selvita research and development programs will be presented in the following poster sessions:

• The poster presentation recapping the most recent results of SEL120 project development, entitled “CDK8 inhibitor SEL120-34A targets CD34 positive AML cells by regulation of various transcriptional programs involved in maintenance of leukemia stem cells”, Abstract no. 5829, will take place on Wednesday, April 18, between 8:00 AM – 12:00 PM, during the session “Experimental and Molecular Therapeutics”; “Combination Chemotherapy 2”, in the McCormick Place South, Exhibit Hall A, Poster Section 37, poster board #25.

• The poster presentation entitled: “Discovery of novel SHMT small molecule inhibitors for cancer treatment”, Abstract no. 3516, will take place during the session “Molecular and Cellular Biology / Genetics”; “Therapeutic Approaches”, on Tuesday, April 17, between 8:00AM – 12:00 PM, in the McCormick Place South, Exhibit Hall A, Poster Section 22, poster board #13.

• The poster presentation entitled: “Characterization of novel dual A2A/A2B adenosine receptor antagonists for cancer immunotherapy”, Abstract no: 3770, will take place during the session “Immunology”; “Immunomodulatory Agents and Interventions 1”, on Tuesday, April 17, between 8:00AM – 12:00 PM, in the McCormick Place South, Exhibit Hall A, Poster Section 32, poster board #20.

Selvita Oncology Pipeline
In its internal research and development efforts, Selvita focuses on different dimensions of oncology. The company’s most advanced R&D program is SEL24, a dual PIM/FLT3 kinase inhibitor currently in Phase I/II clinical study, which was exclusively licensed to Menarini Group in March 2017. The second most advanced program is SEL120, a first-in-class small molecule inhibitor of CDK8 with potential use in hematological malignancies, colorectal cancer and breast cancer. In August 2017, Selvita signed a partnering agreement with The Leukemia and Lymphoma Society for preclinical and Phase I clinical development of SEL120 in area of AML, within the Therapy Acceleration Program. Several Selvita’s research programs have been partnered with Merck/EMD Serono, H3 Biomedicine/Eisai and Nodthera. Selvita Early Discovery Programs are focused on a number of novel oncology targets in the area of kinase inhibitors, cancer metabolism & immunometabolism and immunooncology.

About Selvita
Selvita S.A. is a clinical stage drug discovery company engaged in the research and development of novel cancer therapies, as well as provision of integrated drug discovery services. Selvita is headquartered in Krakow, Poland, with offices in the USA (Greater Boston, San Francisco Bay), and in the UK (Cambridge). Selvita has currently several projects at early or late discovery stage. Drug discovery clients of Selvita include numerous large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. The company is listed on the Warsaw Stock Exchange (WSE:SLV).

Contact

Natalia Baranowska
natalia.baranowska@selvita.com
+48 784 069 418

Global leader in organ-on-a-chip technology backed by international syndicate for worldwide commercial expansion and new product development

Leiden, the Netherlands, April 11, 2018 / B3C newswire / --MIMETAS, leader in organ-on-a-chip products and tissue models, has secured 20.5 million USD in financing from an international syndicate from Asia and Europe. MIMETAS will use the proceeds of this Series B financing round to expand its global commercial footprint with the OrganoPlate® organ-on-a-chip platform. In addition, the company will broaden its product portfolio, establish tissue production facilities, develop novel OrganoPlate® products and expand into clinical market segments, including personalized medicine. The company has operations in the Netherlands, USA and Japan.

Investors are European Life Sciences Growth Fund (ELSGF, Singapore), Aglaia Oncology Fund II (the Netherlands), Korys (Belgium), Cathay Venture (Taiwan), InnovationQuarter and Oost NL (the Netherlands).

Ginger Hsiao, fund manager of ELSGF, acting as spokeswoman for the syndicate: “From the start, we were impressed by MIMETAS’s technology and highly talented team. We consider the company as today’s leader in the organ-on-a-chip space with tremendous growth potential in the coming years. Its customer base already includes leading multinationals from Europe, US and Asia and the adoption of the platform ranges from academic users to high-throughput screening facilities for pharmaceuticals. We are looking forward to supporting the MIMETAS team with their commercial expansion and addressing new markets.”

“This strong investor base ticks all the boxes for MIMETAS in this phase of corporate development.”, according to founders Jos Joore and Paul Vulto,“Korys has solid expertise in product commercialization at the interface of hardware and biology, while Aglaia brings a wealth of clinical and oncology expertise to the company. ELSGF and Cathay will support the company in expanding in the Asian market. This is complemented with local support from Oost NL and InnovationQuarter.”

 
About MIMETAS
MIMETAS (Leiden, the Netherlands, Gaithersburg, USA) provides organ-on-a-chip products for compound testing, screening and fundamental research. Its flagship product, the OrganoPlate®, supports 3D cell culture under continuous perfusion, with membrane-free co-culture and epithelial and endothelial tubules. The company develops and validates customized disease, toxicology and transport models and ultimately will make its technology available for personalized therapy selection. MIMETAS has developed models for the kidney, liver, gut, brain and a range of oncological applications, that offer better predictivity towards human physiology as compared to laboratory animals and conventional cell culture models. Since its commercial launch in 2014, MIMETAS has grown its customer base to half of the global top-50 pharmaceutical companies, in addition to chemical, food and consumer goods companies. The fast market acceptance of the OrganoPlate® is driven by its unsurpassed ease-of-use and throughput, in combination with complex human biology and disease relevance.

About European Life Sciences Growth Fund (ELSGF)
ELSGF is a private capital fund investing in ‘Best of Europe’ Life Sciences for growth into the Asian markets. The fund creates value by building out a presence in Asia for its portfolio companies and adding revenue from the region to their existing business. The fund is managed by Pilgrim Partners Asia in Singapore.

About Aglaia
Aglaia invests in ground-breaking technologies that have the potential to translate into solutions for the prevention and treatment of cancer. Aglaia is actively involved in the companies it invests in. By translating high-potential research into commercially and clinically successful products Aglaia gives meaning to the concept of impact investing.

About Korys
Korys is a family-owned holding company investing in non-listed companies, private equity funds and managing a portfolio of listed investments. Today, it has more than EUR 4 billion of assets under management, among which a significant participation in Colruyt Group, a leading retail company in Belgium and France. Investment decisions are taken with a long-term perspective on the basis of economic, ecological and social merit. Korys aims to create sustainable value through a diversified portfolio of investments. Korys has a team of more than 20 professionals based in Belgium and Luxembourg.

About Cathay Venture
Cathay Venture is an evergreen fund, wholly-owned by Cathay Financial Holdings, based in Taipei, Taiwan. Cathay Financial Holdings is the largest financial group in Taiwan, with registered capital of USD 4 billion. Composed of insurance, securities, banking and other diversified financial institutions, Cathay Financial Holdings is a multi-faceted financial platform servicing more than 13 million customers in Asia. Cathay Venture is committed to maximizing the potential and value of its portfolio companies with its comprehensive network.

About Oost NL
Oost NL (East Netherlands Development Agency) is an agency that focuses its activities and projects on strengthening and stimulating the economy of the provinces of Gelderland and Overijssel, the Netherlands. Oost NL acts as a bridge between government, companies and knowledge institutes and supports starting and growth-phase SMEs. Oost NL does this partly with risk capital from various revolving innovation funds, and partly through our knowledge, networks and personal contacts. With this investment, Oost NL supports employment opportunities at the production site of Mimetas at the High Tech Factory in Enschede.

About InnovationQuarter
InnovationQuarter is the regional economic development agency for West Holland. InnovationQuarter finances innovative and fast-growing companies, assists international companies in establishing their businesses in West Holland, and facilitates (international) collaboration between innovative entrepreneurs, knowledge institutes and government. In this way, and in cooperation with the business community, InnovationQuarter supports the development of West Holland to become one of the most innovative regions in Europe.

Contact

MIMETAS BV
Jos Joore, co-CEO
pr@mimetas.com
+31 85 888 3161

Bangalore, India, April 11, 2018 / B3C newswire / --Aurigene will present data for its

1. Proprietary novel, first-in-class, small molecule antagonists of CD47-SIRPα interaction program which is currently in late preclinical stage. Aurigene plans to file an IND by Q4 2018
2. Preclinical stage, novel, selective PRMT5 inhibitors
3. Lead optimization stage covalent, highly selective CDK12 inhibitors program and
4. Selective, degrader of SMARCA2/4

Additional information on the presentations can be found below and abstracts can be accessed at www.aacr.org.

Additional details of our pipeline available for partnering can be found at: http://www.aurigene.com/proprietary-programs/ 

Poster Presentations

Small Molecule, Oral antagonists targeting CD47- SIRPα
Title: Combination efficacy and safety profile of an orally bioavailable small molecule agent targeting CD47/SIRPα axis

Session Category: Experimental and Molecular Therapeutics
Session Title: Novel and Canonical Targets
Session Date and Time: Tuesday Apr 17, 2018 8:00 AM - 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 35
Poster Board Number: 18
Permanent Abstract Number: 3852  

Covalent, selective, CDK12 inhibitors
Title: Preclinical evaluation of PD and efficacy of novel potent selective and orally bioavailable CDK12 covalent inhibitors in TNBC model

Session Category: Molecular and Cellular Biology / Genetics
Session Title: Kinases and Phosphatases
Session Date and Time:Monday Apr 16, 2018 1:00 PM - 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 17
Poster Board Number: 21
Permanent Abstract Number: 2384  

Selective PRMT5 inhibitors
Title: Preclinical In vivo evaluation of efficacy, pharmacokinetics and pharmacodynamics of novel PRMT5 inhibitors in multiple tumor models

Session Category: Molecular and Cellular Biology / Genetics
Session Title: Epigenetic Therapy
Session Date and Time: Monday Apr 16, 2018 8:00 AM - 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 16
Poster Board Number: 16
Permanent Abstract Number: 1392 

SMARCA2/4 degraders
Title: Identification of SMARCA2/4 degraders for the treatment of SMARCA4-mutant and other cancers

Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Session Date and Time: Tuesday Apr 17, 2018 1:00 PM - 5:00 PM
Session Location: McCormick Place South, Poster Section 43
Poster Board Number: 2
Permanent Abstract Number: LB-258        

 
About Aurigene
Aurigene is a specialized biotechnology company, engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene is focused on oral check-point inhibitors, precision-oncology and the Th-17 pathway.  Aurigene’s oral PD-L1/ VISTA antagonist program is currently in Phase 2 clinical development in India (trial initiated by Aurigene). Aurigene has filed an IND for its RORg program for autoimmune diseases and expects to initiate Phase I studies by Jun-2018. Aurigene has also developed selective CDK7 inhibitors with a likely IND by Q4 2018. Aurigene has partnered with several large- and mid-pharma companies in the United States and Europe and has delivered over 15 compounds which are in clinical development.

 
Contact

Rajshree KT
Director Strategic Alliances
pr@aurigene.com
+91 - 40 - 4465 7777

• Agreement strengthens Orchard’s position as a global leader in gene therapy for rare diseases
• GSK takes 19.9% equity stake in Orchard and seat on board

London UK, April 12, 2018 / B3C newswire / -- GSK and Orchard Therapeutics today announced a strategic agreement, under which GSK will transfer its portfolio of approved and investigational rare disease gene therapies to Orchard, securing the continued development of the programmes and access for patients. This acquisition strengthens Orchard’s position as a global leader in gene therapy for rare diseases. GSK will continue to invest in the development of its platform capabilities in cell and gene therapies, with a focus on oncology.

Under the agreement, GSK will become an investor in Orchard Therapeutics, receiving a 19.9% equity stake along with a seat on the company’s board. GSK will also receive financial considerations in the form of royalties and commercial milestone payments related to the acquired portfolio. GSK and Orchard will exchange manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.

Orchard Therapeutics is a clinical-stage gene therapy company based in the United Kingdom and United States, dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. The acquisition of GSK’s programmes complements Orchard’s pipeline of clinical and preclinical gene therapies for primary immune deficiencies and inherited metabolic disorders.

The portfolio of gene therapy programmes Orchard has acquired includes: Strimvelis, the first autologous ex vivo gene therapy for children with adenosine deaminase severe combined immunodeficiency (ADA-SCID), approved by the EMA in 2016, two late-stage clinical programmes in ongoing registrational studies for metachromatic leukodystrophy (MLD) and Wiskott Aldrich syndrome (WAS), and one clinical programme for beta thalassaemia. Orchard will also acquire rights to exclusively license three additional preclinical programmes from Telethon/Ospedale San Raffaele upon completion of clinical proof of concept studies for mucopolysaccharidosis type 1 (MPS1 or Hurler syndrome), chronic granulomatous disease (CGD) and globoid cell leukodystrophy (GLD). 

The agreement follows GSK’s strategic review of its rare disease unit, announced in July 2017, as part of the Group’s ongoing prioritisation and strengthening of its pharmaceuticals pipeline with a focus on priority programmes in two current therapy areas, respiratory and HIV/infectious diseases, and two potential areas, oncology and immuno-inflammation.

John Lepore, Senior Vice President, R&D pipeline, GSK, said: “GSK is proud of the advances we have achieved in collaboration with the cell and gene therapy pioneers at Ospedale San Raffaele, Fondazione Telethon and MolMed in Milan.  Since we announced our intent to review these medicines, our goal has been to identify the right owner who can build on what we’ve already achieved, and can advance these important medicines for patients, allowing GSK to focus on building its broader cell and gene therapy platform capabilities. Orchard are committed to patient access, and we’re confident that this agreement combined with the ongoing relationship between the two companies will support the progression of these valuable programmes to enable them to benefit patients.”

Mark Rothera, CEO, Orchard, said: “Acquiring this portfolio further advances Orchard’s vision to be a global, fully integrated company leading the field of gene therapy for rare diseases. The acquisition immediately expands our primary immune deficiency and inherited metabolic disorder franchises and adds the potential for other franchises in the future. At Orchard, we are committed to transforming the lives of patients with rare diseases through innovative gene therapies. We look forward to building upon the great achievements of GSK and its collaborators. This acquisition and the planned transfer of the agreement with MolMed secure the continued development of GSK’s programmes and leverages Orchard’s deep expertise and capabilities. In the two late stage programmes MLD and WAS for example, the clinical data* are very encouraging and we look forward to continuing to progress development.”

Francesca Pasinelli, General Manager of Fondazione Telethon, said: “We are confident that the agreement between GSK and Orchard Therapeutics represents a good opportunity for the future prospects of the gene therapy programmes developed at the San Raffaele-Telethon Institute for Gene Therapy. Orchard Therapeutics’ commitment to rare diseases will secure continuity of efforts for all diseases in the pipeline. As a charity born out of patients' need, this will enable us to fulfil our vision, which is to bring viable therapies to people struggling with rare genetic disease.”

Orchard Therapeutics will assume all obligations arising from GSK’s 2010 collaboration agreement with the Ospedale San Raffaele and Fondazione Telethon and from GSK’s collaboration agreement with MolMed. 

In order to support a smooth transition of these programmes with minimal disruption to the projects, both companies have agreed to a transition period during which GSK will continue to conduct certain activities through to the end of 2018.

 
About autologous ex vivo gene therapy
Autologous ex vivo gene therapy is a novel personalised treatment approach that can be used to address rare genetic disorders using the patient's own stem cells. Haematopoietic stem cells are taken from the patient and genetically corrected outside of the body (ex vivo) with a viral vector carrying a functioning copy of the missing or faulty gene. The genetically corrected cells are then transplanted back into the patient. The use of the patient's own cells provides a perfect biological match. This eliminates the requirement for a donor search and the risk of failed engraftment or graft-versus-host disease which are major complications of transplants from a third-party donor. Orchard Therapeutics is committed to maintaining access to Strimvelis for patients in Europe.

About GSK
a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

About Orchard Therapeutics
Orchard Therapeutics is a privately held clinical-stage biotechnology company dedicated to transforming the lives of patients with rare and life-threatening diseases by developing innovative gene therapies. Orchard, based in the UK and US, with a presence in London, San Francisco and Boston, has partnered with world leaders in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles and Boston Children’s Hospital. Orchard’s growing pipeline of autologous ex vivo lentiviral gene therapy programmes for rare immune deficiencies and metabolic disorders includes late clinical stage programmes that have already provided transformative treatment for patients with rare genetic diseases. In 2016 the company was named a Fierce 15 Company by Fierce Biotech and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM) to advance their autologous ex vivo lentiviral gene therapy in ADA-SCID. In 2017, Orchard raised $110 million in a Series B round of funding to further develop its pipeline in parallel with enhancing manufacturing capabilities.

Contacts

GSK UK media enquiries
Simon Steel, +44 (0) 20 8047 5502 (London)
David Daley, +44 (0) 20 8047 5502 (London)

GSK US media enquiries
Sarah Spencer, +1 215 751 3335 (Philadelphia)
Mary Anne Rhyne, +1 919 483 0492 (North Carolina)

GSK analyst/investor enquiries
Sarah Elton-Farr, +44 (0) 208 047 5194 (London)
Tom Curry, + 1 215 751 5419 (Philadelphia)
James Dodwell, +44 (0) 20 8047 2406 (London)
Jeff McLaughlin, +1 215 751 7002 (Philadelphia)

Orchard corporate enquiries
Mary D. Wallace, +1 781 608 3666 (Boston)

Orchard media enquiries
Allison Blum, +1 516 655 0842 (New York)

 
GSK cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2017.

* References:

1. Sessa et al. Lentiviral haemopoietic stem-cell gene therapy in early-onset metachromatic leukodystrophy: an ad-hoc analysis of a non-randomised, open-label, phase 1/2 trial. The Lancet 2016, DOI:
   http://dx.doi.org/10.1016/S0140-6736(16)30374-9
2. Aiuti A et al. Lentiviral hematopoietic stem cell gene therapy in patients with Wiskott-Aldrich syndrome; Science 2013; Aug 23;341(6148)

• Icosabutate, a structurally engineered fatty acid, displays optimised phamacokinetics for targeting both metabolic and inflammatory pathways in the liver, both with key relevance for NASH
• Pre-clinical data show broad and powerful pharmacodynamic effects on plasma lipids, glucose metabolism, hepatic inflammation and fibrosis
• Clinical phase 2 data study demonstrated normalisation of elevated baseline liver enzymes in dyslipidemic patients treated with icosabutate 600mg once daily for 12 weeks
• The combined data provide a strong impetus for phase 2b NASH trial initiation in late 2018

Naarden, The Netherlands, April 12, 2018 / B3C newswire / --NorthSea Therapeutics B.V., (‘NST’) a newly established Dutch biotech company aiming to develop novel and innovative strategies for the treatment of NASH and other metabolic, inflammatory and fibrotic diseases, announces the publication of a late-breaker abstract and poster to be presented at The EASL International Liver Congress™ 2018 in Paris on 12-14 April. 

NorthSea Therapeutics’ lead product, icosabutate is a structurally designed fatty acid that regulates pivotal lipid pathways involved in hepatic inflammation and fibrosis.

Commenting on the late-breaker category, Dr. David A. Fraser, CSO, said:“The late-breaker category is devoted to novel and outstanding scientific discoveries, therefore, we are delighted to be accepted to present our data in this class. The International Liver Congress™ 2018 provides us with the ideal platform to demonstrate the unique therapeutic potential of structurally engineered fatty acids, as exemplified here by icosabutate, for pleiotropic targeting of metabolic and inflammatory liver disorders. With this data, we are on track to take this programme into Phase 2b later this year.”

The presented data indicate that icosabutate has favourable pharmacokinetics, and significant therapeutic benefit in animal models of NASH and overall diet-induced inflammation and fibrosis. In particular, icosabutate is shown to improve glucose tolerance in insulin resistant rodent models.

In a 12-week phase 2 clinical study in dyslipidemic patients, icosabutate markedly decreased elevated liver enzymes at a well-tolerated 600mg once daily oral dose (CTN 4016 13201), whereas enzyme levels were unchanged in patients taking placebo. Decreases in liver enzymes are known to correlate with positive histological responses to therapeutic interventions in clinical trials in NASH, and hence these data strongly support the pre-clinical observations demonstrating the robust hepatoprotective and antifibrotic effect of icosabutate in NASH models.

Professor Detlef Schuppan, Scientific Advisory Board member and world-renowned expert in liver fibrosis and NASH, said, “Icosabutate is an exciting potential drug as it exhibits highly potent effects on hepatic inflammation, in addition to improvements in insulin resistance and antifibrotic potency. We are looking forward to continuing our research on both its antifibrotic and overall mechanisms of action.”

Two previously phase 2 clinical studies on icosabutate have been published already, demonstrating significant triglyceride and cholesterol-lowering effects, significant improvements in glucose metabolism and excellent safety. With this new clinical study, the combined data presented supports the continuing development of icosabutate as an effective and safe therapeutic approach to treating both NASH and its associated comorbidities. Icosabutate is on course to be phase 2b-ready by the end of 2018.

Commenting on the combined preclinical and clinical results, Professor John J. Kastelein, Scientific and Advisory Board member, added:“Next to the robust preclinical data in NASH models, the clinical observations in phase 2 with icosabutate show excellent results. These include a good safety profile, suggest a decrease in liver fat and demonstrate a very attractive reduction of cardiovascular risk through modulation of lipid and glucose metabolism, which other classes of drugs seldom show.”

The poster is available to view on the NorthSea Therapeutics website: www.northseatherapeutics.com/easl-latebreaker

For more information please visit the NorthSea team in the poster area of the conference:

Poster title: A structurally engineered fatty acid, icosabutate, displays optimised absorption, distribution and metabolism properties for targeting hepatic inflammation and normalises elevated liver enzymes in dyslipidemic patients
Authors: Fraser DA, Wang X, Skjaeret T, Kastelein JP, Schuppan D
Date: 09:00 – 17:00 Thursday 12th to Saturday 14th April
Location: Hall 7.2, poster area 2, LBP-026

About NASH
NASH is liver inflammation and damage caused by a build-up of fat in the liver. It is the advanced stage non-alcoholic fatty liver disease (NAFLD), which start with fatty liver and insulin resistance. Although a similar condition can occur in people who abuse alcohol, NASH occurs in those who drink little to no alcohol. It is frequently associated with certain disorders such as diabetes, obesity, and insulin resistance which are major contributors to the highly prevalent metabolic syndrome. An estimated 15 – 30% of most populations suffers from NAFLD, 10 – 15% of whom may advance to NASH representing at least ~15 – 30 million patients in the 6 major markets. Further disease progression in 15-20% of NASH patients leads to advanced liver fibrosis and cirrhosis with a high risk of liver failure, hepatocellular cancer and need for liver transplantation.

About NorthSea Therapeutics
NorthSea Therapeutics B.V.(NST) is a biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic and liver diseases. NST licensed the rights to its lead compound icosabutate and a library of discovery- and pre-clinical-stage SEFAs from Pronova BioPharma Norge AS, who developed Omacor^Ò, a blockbuster cardiovascular drug.  Icosabutate has been found safe and effective in two prior phase 2 clinical studies for treatment of hypertriglyceridemia and is currently in clinical development for NASH, aiming to be phase 2b ready by end 2018. NST is a Dutch company, with employees based also in the UK and Norway.

Contacts

NorthSea Therapeutics B.V.
Rob de Ree (CEO)
rob.deree@northseatherapeutics.com
+31 356993000

Media Contact

Instinctif Partners
Dr Christelle Kerouedan / Melanie Toyne-Sewell
NorthSea@instinctif.com
+44 20 7457 2020

London, UK and Carlsbad, CA, USA, April 13, 2018 / B3C newswire / --DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections that can lead to sepsis, announces that new data will be presented on its LiDia® Bloodstream Infection (BSI) test(1)(2) at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018.

A demonstration of the blood-to-result workflow for LiDia® BSI will be previewed at DNAe’s booth at ECCMID.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “ECCMID comes at a pivotal time in our journey to bring this vital rapid diagnostic test to market. We are pleased to present key data and look forward to reaching more of the infectious disease community at the event this year. The congress gives us an excellent opportunity to showcase the LiDia® BSI closed cartridge-based test for the first time to a wide clinical audience at our stand, and to demonstrate its potential to support faster and more informed treatment of sepsis.”

Details of the poster presentation are as follows:

Poster Presentation – #P1960

Title: Rapid Detection of Clinically-Confirmed Bloodstream Pathogens in Culture-Negative Specimens'
Time and Date: 12:30 pm - 1:30 pm CEST, Tuesday, 24th April
Session: Diagnostic Approaches in Bacterial Bloodstream Infection
Location: Paper Poster Arena

The abstract is available online, here.

DNAe’s Dr Steve Allen, Nick McCooke, Dr Nour Shublaq, Dr Nicola Casali and Alexandra Barr will be available to discuss the data. To arrange a meeting, email contact@dnae.com.

LiDia® BSI Demonstrations

Demonstrations will take place at DNAe’s booth between the following times:

12:00 noon – 6 pm CEST, Saturday, 21st April
9.30 am – 5 pm CEST, Sunday, 22nd April
9.30 am – 5 pm CEST, Monday, 23rd April
9.30 am – 2 pm CEST, Tuesday, 24th April                        

Location: Booth #104

If you would like to reserve a demonstration timeslot please RSVP in advance online, here.

Operating as a closed cartridge-based test, LiDia® BSI utilizes highly sensitive sample preparation and semiconductor-based PCR analysis to rapidly identify pathogens and key antibiotic resistance markers. Aiming to deliver clinically actionable results straight from raw blood specimens in under 3 hours, LiDia® BSI will aid patient management by offering a significant reduction in time-to-result compared to the current standard of culture-based diagnosis, which generally requires several days to produce a result.

 
About DNAe
DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Contact

DNAe
Dr Steve Allen, Chief Executive Officer, DNAe Group
+44 (0)20 7036 2100

Instinctif Partners (media relations)
Sue Charles / Ashley Tapp / Alex Bannister
+44 (0)20 7457 2020
DNAe@instinctif.com

(1) Test in development. For Research Use Only. Not for use in diagnostic procedures
(2) This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

The Aryl Hydrocarbon Receptor (AHR) as a Driver of Cancer Immunosuppression

Leiden, The Netherlands, April 13, 2018 / B3C newswire / -- Hercules Pharmaceuticals, a Dutch biopharmaceutical company developing innovative anti-cancer drugs will present a poster,  Poster LB-128, at the AACR meeting in Chicago on Monday April 16, 2018, from 8:00am-12:00pm, Poster section 45. The poster will be presented by, amongst others, Prof. David Sherr, co-founder of Hercules and international key opinion leader in the field of cancer immunology at Boston University.

The results presented show that the Aryl Hydrocarbon Receptor (AhR) is an important driver of cancer and cancer immuno suppression and that AhR inhibition could have powerful anti-cancer effects. Acting downstream of IDO inhibitors, Hercules’ AhR inhibitor HP163 promise to be more effective in blocking the tryptophan>IDO/TDO>kynurenine>AhR pathway.

The crucial role of AhR in cancer was demonstrated in a syngeneic murine cancer model, where animals received cancer cells from which the AhR was removed by Crispr Cas. Absence of AhR in tumor cells completely blocked tumor growth.

Where AhR knock-down shows the maximum achievable effect of AhR inhibition, Hercules’ AhR inhibitor HP163 already demonstrates better tumor growth reduction than IDO inhibitor epacadostat in a syngeneic murine colon cancer model.

It is Hercules’ aim to develop AhR inhibitors that have single agent efficacy in cancer patients. Furthermore, there is good scientific rationale for combining AhR inhibitors with other anticancer approaches, like anti PD-1/L1 antibodies and IDO inhibitors.

  
About Hercules
Hercules is a private biopharmaceutical company, based in The Netherlands. The company was founded in 2013 to develop and commercialize the inventions of Professor David Sherr, an international key opinion leader in the field of cancer immunology at Boston University. Professor Sherr demonstrated that the Aryl Hydrocarbon Receptor plays an important role in the occurrence and progression of cancer. He also discovered that blocking the Aryl Hydrocarbon Receptor with  small molecule drugs is a promising and novel way to treat solid tumors, including Triple Negative Breast Cancer, Glioblastoma and Head and Neck cancer. Hercules lead compound HP163 is in pre-clinical development.

 
Contacts

Hercules Pharmaceuticals
Bart Wuurman, CEO
bart.wuurman@hercules-pharma.nl
Galileiweg 8, 3222BD Leiden, The Netherlands
+31 64 66 23 735
www.hercules-pharma.nl

LifeSpring Life Sciences Communication
Léon Melens
+31 (0)6 – 538 16 427
lmelens@lifelspring.nl

University Park, Pennsylvania, USA, Goettingen, Germany, April 16, 2018 / B3C newswire / --Sartorius Stedim Biotech and Penn State University have entered into a collaborative partnership to advance multidisciplinary teaching and research in biotechnology. This long-term relationship will support the education and preparation of the next generation of biotechnology leaders. Part of Sartorius’ investment will be to enhance the Fermentation Facility that will play a significant role in Penn State’s Center of Excellence in Industrial Biotechnology (CoEIB). Sartorius will provide state-of-the-art fermentation technologies, and a central laboratory within the Fermentation Facility will be named the Sartorius Fermentation Gallery.

“We are grateful to Sartorius for their commitment to and investment in biotechnology at Penn State,” said O. Richard Bundy III, Penn State’s vice president for development and alumni relations.“Sartorius is a global leader in research and manufacturing technologies in the field of biotechnology. Their support will enable Penn State to provide an environment that closely matches what is available in today’s premier research and manufacturing facilities, further elevating the University’s leadership position in this rapidly growing field.”

Sartorius views this partnership as an opportunity to create a hub that will promote innovation in biotechnology. “We look forward to bringing together future thought leaders within the new Sartorius Fermentation Gallery,” said Reinhard Vogt, member of Executive Committee of Sartorius Stedim Biotech.“The innovative bioanalytical and bioprocess technologies of Sartorius will enable these scientists to accelerate progress in biotechnology.”

Sartorius, together with additional industry partners, has been supporting Penn State for more than a year in designing the new lab space and in equipping it based on the latest technologies.

The Fermentation Facility is one of ten core facilities in the Huck Institutes of the Life Sciences and the cornerstone of Penn State’s comprehensive biotechnology effort. This effort includes the CoEIB, recently launched with a landmark gift from CSL Behring. The CoEIB provides a focal point for Penn State’s programs in the area of industrial biotechnology, including the development of research and educational initiatives focused, among other areas, on biopharmaceutical manufacturing, i.e., the manufacture of medical drugs from biological sources.

“Biotechnology has implications for the medicines we take, the food we eat, the fuel we fill our cars with, and more, but researchers working and students training in this area require world-class facilities and equipment in order to move this field forward,” said Peter Hudson, director of the Huck Institutes of the Life Sciences and Willaman Professor of Biology.“I am grateful to Sartorius for providing state-of-the-art equipment that will drive innovation for years to come.”

Underpinning the growth and sustainability of the CoEIB’s vision, as well as its contribution to the future of industrial biotechnology, is the active participation of alumni, friends, and corporate and foundation partners. To discuss how you or your organization can collaborate with the CoEIB, please contact Wendy Oakes at wendyoakes@psu.edu or +1 814-865-7085.

 
About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2017, the company employed approx. 5,100 people and earned sales revenue of 1,081.0 million euros.

About “A Greater Penn State”
Gifts from Penn State's alumni, friends and corporate and foundation partners have been essential to the success of the University's historic land-grant mission to serve the public good. To fulfill that mission for a new era of rapid change and global connections, the University has begun “A Greater Penn State for 21st Century Excellence,” a fast-paced campaign focused on the three key imperatives of a public university: Private support will keep the doors to higher education open to hardworking students regardless of financial well-being; create transformative experiences that go beyond the classroom; and impact the world by fueling discovery, innovation and entrepreneurship.

 
Contacts

Sartorius Stedim Biotech
Timo Lindemann
Corporate Communications
+49 (0)551.308.4724
timo.lindemann@sartorius.com
www.sartorius-stedim.com

Penn State
Wendy Oakes
Associate Director Corporate and Foundation Relations
+1 814.865.7085
wendyoakes@psu.edu
www.greaterpennstate.psu.edu

• Wacker takes over SynCo Bio Partners of Amsterdam
• Capacity of acquired fermentation plant for pharmaceutical actives totals some 2,000 liters – Wacker Biotech’s overall capacity doubles as a result
• SynCo’s expertise in manufacturing live microbial products and in filling finished pharmaceuticals expands Wacker’s portfolio
• Plant acquisition is a key step for Wacker, supporting ongoing expansion in the high-growth biopharmaceuti­cals market and securing sufficient GMP production capacities for existing and new customers

Munich, Germany and Amsterdam, the Netherlands, April 17, 2018 / B3C newswire / -- Wacker Chemie AG has acquired a Dutch site for manufacturing biopharmaceuticals, live microbial products and vaccines, plus the associated business, from SynCo Bio Luxembourg S.à.r.l.. The Munich-based chemical company announced the acquisition today. For WACKER, maintaining SynCo’s existing customer relationships is a top priority. Moreover, WACKER is keeping on SynCo’s employees. Both parties have agreed not to disclose the purchase price.

“This strategic acquisition is a key step for our ongoing expansion in the high-growth biopharmaceuticals market,” explained Auguste Willems of WACKER’s Executive Board.“The new plant will enable us to satisfy robust market demand today and in the coming years – and to strengthen our position as a leading contract manufacturer of microbial-derived biopharmaceutical proteins.”

Founded in 2000, SynCo Bio Partners has some 110 employees and operates two fermentation lines with current capacities of 1,500 and 270 liters. These lines manufacture microbial-derived biopharmaceuticals, not only for clinical testing, but also for the commercial market. There is a further line of single-use fermenters, which provides additional and flexible production capabilities. SynCo’s service offering is rounded out with a “fill and finish” facility, which enables the complete manufacture of pharma­ceuticals from the active agent to the filled product. The facilities meet “Good Manufacturing Practice” (GMP) quality standards, and they have already been inspected by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) and approved for the manufacture of specific pharmaceutical proteins.

“Expanding our production capacity strengthens our market position sustainably,” said Gerhard Schmid, president of WACKER BIOSOLUTIONS.“The additional fermentation lines double our current capacity, which increases our ability to produce key pharmaceuticals cost effectively, using advanced microbial techniques. We look forward to continuing the comprehensive support for SynCo’s existing customers, while also offering them the proprietary technologies of Wacker Biotech. The acquisition will significantly expand our portfolio of technologies and services.”

SynCo’s expertise in manufacturing live microbial biopharmaceuticals is a valuable complement to WACKER’s know-how as a full-service supplier. Live microbial products represent a promising new class of actives, offering innovative therapies for serious illnesses and new vaccines against cholera, for example.

About Wacker Biotech
Wacker Biotech GmbH is a full-service contract manufacturer of bio­pharmaceutical proteins based on microbial systems. The company’s services range from molecular biology, analytical services and process development through to the GMP-compliant manufacture of clinical test samples and pharmaceutical actives for the commercial market at its German-based Jena and Halle plants, which are GMP compliant, and FDA and EMA certified. Above all, Wacker Biotech offers proprietary technolo­gies that satisfy market needs for cost-efficient production and maximum quality. Wacker Biotech is a wholly-owned WACKER subsidiary.

 
Contact

Wacker Chemie AG
Media Relations & Information
Christof Bachmair
+49 89 6279-1830
christof.bachmair@wacker.com
www.wacker.com

The Company in Brief:
WACKER is a globally-active chemical company with some 13,800 employees and annual sales of around € 4.9 billion (2017). WACKER has a global network of 23 production sites, 21 technical competence centers and 50 sales offices.                                                                                                                            

WACKER SILICONES
Silicone fluids, emulsions, rubber grades and resins; silanes; pyrogenic silicas; thermoplastic silicone elastomers

WACKER POLYMERS
Polyvinyl acetates and vinyl acetate copolymers and terpolymers in the form of dispersible polymer powders, dispersions, solid resins and solutions

WACKER BIOSOLUTIONS
Biotech products such as cyclodextrins, cysteine and biologics, as well as fine chemicals and PVAc solid resins

WACKER POLYSILICON
Polysilicon for the semiconductor and photovoltaic industries