Freiburg, Germany, June 21, 2018 / B3C newswire / --CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion as more customers approach late-stage clinical development and commercialization.

In a first step, the company added additional space to its headquarters in Freiburg, Germany. Quality control, research and development laboratories as well as logistics and warehouse space have already been put into operation.

As the next step, a state-of-the-art, automated filling and freeze-drying line will be implemented in the existing GMP facility increasing finished product capacity for recombinant proteins by more than tenfold. This second phase of expansion is expected to be completed in the spring of 2019.

Positive clinical data, a supportive financing climate and clearer regulatory requirements have led to a strong growth in the cell and gene therapy space. This is predicted to persist. The building extension allows CellGenix to continue meeting the increasing demands for GMP-grade raw materials as more and more promising cell and gene therapies approach market authorization and commercialization.

“We are really excited about our new facility and the additional flexibility it provides. It supports our goal to become a key provider in the fight against disease, the preferred supplier of raw materials and tools and trusted partner for large scale manufacturing in the cell, gene therapy and regenerative medicine space. The expansion of our facility is a result of the robust, sustainable and profitable growth we achieved over the last years,” says Prof. Dr. Felicia Rosenthal, CEO of CellGenix.

Frank Hecht, Vice President Marketing & Sales at CellGenix, adds:“With this expansion we strengthen our position as a leading partner for all companies active in the manufacturing of cell and gene therapies. It enables us to meet increasing demands for high quality raw materials and, ultimately, help more patients.”

About CellGenix
CellGenix is a leading manufacturer and developer of premium-grade reagents for clinical cell culture needs. The company has more than two decades of in-house expertise in GMP manufacturing and development of products in the field of cell therapy, gene therapy and regenerative medicine. The superior quality GMP reagents are used by leading experts and are proven in clinical trials and commercial manufacturing throughout the world. CellGenix is headquartered in Freiburg, Germany and operates a subsidiary in Portsmouth, New Hampshire, USA, serving the North American market.

 
Contact

CellGenix GmbH
Prof. Dr. Felicia M. Rosenthal
Chief Executive Officer
+49 761 88889100
publicrelations@cellgenix.com
www.cellgenix.com

Wädenswil, Switzerland, June 26, 2018 / B3C newswire / --Inthera Bioscience AG, a pre-clinical stage oncology company targeting the inhibition of protein-protein interactions with innovative small molecule chemistry, today announced that three senior Pharma and Biotech Industry members joined its management team.
Bernd Hentsch joins the company as Chief Development Officer, Ralph Lindemann as Chief Scientific Officer and Monique Schiersing as Chief Operating Officer.
The company is also pleased to announce that it secured the second tranche of its Series A financing, bringing the total amount to €9.6 million.

“I am very pleased to see such an experienced group of executives joining Inthera Bioscience. I am convinced that this high caliber team under the leadership of founder and CEO Uli Kessler combined with our unique technology platform and projects make Inthera one of the most exciting and promising Biotech companies in the oncology space in Europe”, said Klaus Schollmeier, Chairman of the Board of Directors.

“Securing the milestone driven second tranche of our Series A financing represents the validation that our platform can deliver drug leads targeting specific intracellular protein-protein interactions. These lead candidates have shown broad anticancer effects in preclinical studies with complete tumor eradication in animal models of solid tumors.
It also shows the confidence of our investors M Ventures, Aglaia BioMedical Ventures and Novo Seeds in the highly innovative approach we are taking to address unmet needs in the field of oncology” says CEO Uli Kessler.“We are in a strong position to select a first orally available small molecule drug candidate soon and move it efficiently towards the clinic”.

Bernd Hentsch, Ph.D. has held various senior positions in the European Biotech industry. Prior to joining Inthera Bioscience he was Chief Development Officer at 4SC AG, a German clinical stage oncology company and TopoTarget A/S, a Danish clinical stage oncology company. Prior to TopoTarget A/S, Bernd has held other R&D related positions, e.g. in Germany at Merck KGaA, Darmstadt, the German Cancer Research Center, Heidelberg, and at the Walter and Eliza Hall Institute in Melbourne, Australia.

Ralph Lindemann, Ph.D. joins Inthera Bioscience from Merck KGaA, Darmstadt, Translational Innovation Platform Oncology. He has 15 years of experience in translational research and drug discovery and an academic track record in chromatin-based therapeutics.

Monique Schiersing, M.Sc., MBA served previously as Investment Director at the Roche Venture Fund, F. Hoffmann–La Roche AG’s corporate venture fund. In this role Monique served as Director on the board of various Biotech companies in the US as well as in Europe, amongst others Macrolide Pharmaceuticals, Inc., Minoryx Therapeutics S.L., or mySugr GmbH. Prior to this role, Monique held positions as Principal at BankInvest in Copenhagen and Global Alliance Director at Roche Pharma Partnering in Basel.

 
About Inthera Bioscience AG
Inthera Bioscience is a private biopharmaceutical company located in Wädenswil, Switzerland and focused on developing inhibitors of intracellular protein-protein interactions employing a proprietary technology platform. Rationally designed, these orally bioavailable molecules display hot spot residues on a non-peptidic backbone merging the versatility of small molecules with the specificity of biologics. The broad applicability of the approach has been illustrated against several targets in oncology. The most advanced of these first-in-class therapeutics, an oral modulator of dysregulated transcription, is currently entering the preclinical development stage.

About M Ventures
M Ventures is the strategic, corporate venture capital arm of Merck. Its mandate is to invest in innovative technologies and products with the potential to significantly impact Merck‘s core business areas. From our headquarters in Amsterdam and offices in the US and Israel we invest globally in transformational ideas driven by great entrepreneurs. M Ventures takes an active role in its portfolio companies and teams up with entrepreneurs and co-investors to translate innovation towards commercial success. M Ventures has a significant focus on early-stage investing and company creation including the creation of spin-offs to leverage Merck‘s science and technology base.

About Aglaia BioMedical Ventures
Dutch venture capital firm Aglaia – through its Oncology Funds I and II – 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 and works closely with scientists and management teams in the early stages of development. By translating high-potential research into commercially and clinically successful products Aglaia gives meaning to the concept of impact investing combining financial and social returns.

About Novo Holdings and Novo Seeds
Novo Seeds is the early-stage investment arm of Novo Holdings. Novo Holdings is a private limited liability company wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group, comprising Novo Nordisk A/S, Novozymes A/S and NNIT A/S, and is responsible for managing the Foundation’s assets. In addition to being the major shareholder in the Novo Group companies, Novo Holdings provides seed and venture capital to development-stage companies, takes significant ownership positions in well established companies within the life sciences and manages a broad portfolio of financial assets.

Contact

Inthera Bioscience AG
Dr. Ulrich Kessler
Chief Executive Officer
ulrich.kessler@intherabio.com
+41 43 477 94 66

Proprietary Duck Cell Line Serves as Large-Scale Production-Suitable Cell Substrate

Berlin, Germany, and Basel, Switzerland, June 26, 2018 / B3C newswire / --ProBioGen AG, a premier German service & technology provider for complex therapeutic glycoproteins, virus production and viral vector technologies and Nouscom AG, an oncology company dedicated to development of immunotherapies, today jointly announced signing a license agreement. Under the terms of the agreement, Nouscom will gain access to ProBioGen’s proprietary production platform based on the AGE1.CR® duck retina cell line for production of its viral vectored vaccines.

ProBioGen’s CSO, Dr Volker Sandig said:“We have developed the AGE1.CR® designer cell line, the chemically defined media and the process over many years, aiming to overcome challenges in the production of highly attenuated poxvirus vectors. We are very pleased to see a strong industry demand for our platform and are convinced that Nouscom´s highly innovative vaccine approach will greatly benefit from it.”

Nouscom’s CTO, Dr Stefano Colloca added:“We are very pleased with this new partnership with ProBioGen which allows us to utilize a scalable GMP manufacturing process for production of our viral vectored vaccines. This is an important milestone in our journey towards becoming a clinical stage company.”

About ProBioGen AG
ProBioGen is a premier, Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins viral vectors and vaccine technologies. Combining both state-of-the-art protein and virus platforms, based on ProBioGen’s CHO.RiGHT® and AGE1.CR® expression and manufacturing platforms, respectively, together with intelligent product-specific technologies, yield 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.

About Nouscom AG
Nouscom is a private oncology company developing next generation immunotherapies. Nouscom’s proprietary technology platform, Exovax, harnesses the full power of the immune response by combining viral vectored genetic vaccines based on neoantigens with other immunomodulators.
Nouscom is led by an experienced management team that has worked together for many years in previous successful enterprises, including IRBM/Merck and Okairos (acquired by GSK), and are veterans in the field of genetic vaccines.
Nouscom, which was founded in 2015 and is headquartered in Basel, Switzerland with operations in Rome, Italy, is backed by international life sciences investors: 5AM, Abingworth, LSP (Life Sciences Partners) and Versant Ventures.

 
Contacts

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

NousCom
Marina Udier, PhD
Chief Operating Officer
+41 61 201 1835
info@nouscom.com
www.nouscom.com

• Application of Reapplix’s LeucoPatch® results in significantly higher incidence of healing
• Business update:
  • Established Reapplix Inc in the US and appointed James G Wetrich as President, Reapplix Inc
  • Appointment of Morten Have-Rasmussen as Chief Financial Officer

Birkerød, Denmark, June 26, 2018 / B3C newswire / --Reapplix ApS, the regenerative medicine company, initially focussed on chronic wounds, announces that positive outcome data of an independent Randomized Controlled Trial (RCT) of its LeucoPatch® wound healing platform was presented at the American Diabetes Association 78th Scientific Sessions meeting in Orlando, Florida. The Company has also provided an update on the Company’s progress.

Positive outcome data

LeucoPatch®, marketed in the US as 3CPatch®, is a novel platform technology which provides cells and growth factors concentrated from a small sample of the patients’ own blood to produce a small ‘patch’ at the point of care, with no reagents or additives. This is applied topically for the management of exuding cutaneous wounds.

The multicentre, multinational, observer-blinded RCT, (ClinicalTrials.gov NCT02224742) was undertaken at 32 specialist diabetic foot clinics in the UK, Denmark and Sweden. The aim of the trial was to determine whether the application of LeucoPatch® when used in addition to usual care in a multidisciplinary diabetes foot clinic setting, is superior to usual care alone with regard to complete healing of hard-to-heal diabetic foot ulcers.

269 people were randomized to either usual care or care supplemented by weekly application of LeucoPatch®. The primary outcome measure for the trial was healing within 20 weeks of randomization and the trial found a significantly higher incidence (p=0.0235) of healing (Odds Ratio 1:58, a 58% increased chance of healing) in those receiving LeucoPatch®.

This investigator driven trial was run independently by the sponsors, Nottingham University Hospitals NHS Trust. Reapplix involvement was limited to funding the study.

Niels Erik Holm, Chief Operating Officer and Rasmus Lundquist, Chief Scientific Officer at Reapplix, jointly commented: “This data is an important validation of LeucoPatch® and the positive outcomes it can bring to patients. We are grateful to the investigators, wound care professionals and patients who have taken part in this trial and look forward to bringing our treatment to market enabling those in need to benefit.”

Under the current standard of care, up to 40% of diabetic foot ulcer wounds remain unhealed after one year, meaning that there is a is a clear need for an efficacious and cost-effective treatment option.

Business update

Based on this strong clinical evidence, Reapplix has moved forward with key corporate activities and formed Reapplix Inc, based in Texas to bring the 3CPatch® System to the market in the US.

James G Wetrich has been appointed as President of Reapplix Inc, responsible for building sales in the US market. He brings a wealth of experience in wound care and corporate strategy, having been President and GM USA & LATAM for Mölnlycke Health Care from 2006 to 2014, where he oversaw the creation of its large and successful wound care business. He also ran his own consulting business having had previous roles in corporate and strategic planning at Abbott and VP roles in various US hospital groups.

Additionally, Morten Have-Rasmussen has been appointed as Chief Financial Officer. Morten previously held Finance Director roles at Qiagen and at Exiqon in Denmark.

Graeme Brookes, Chief Executive Officer at Reapplix, commented on the news: “Diabetic foot ulcers are associated with high morbidity and substantial health care costs. Following the positive results of the LeucoPatch® trial, we are moving forward with our plans to build and strengthen Reapplix.
“With the key appointments of Jim Wetrich as President of Reapplix US and Morten Have-Rasmussen as CFO, we are investing for the future. Non-healing wounds are life threatening and we are excited at the potential for our LeucoPatch® technology to help more patients.”

About Reapplix ApS
Reapplix has developed a novel platform technology for regenerative medicine which provides cells and growth factors concentrated from a small sample of the patient’s own blood and addresses unmet needs in tissue healing.
Reapplix’s unique technology, including the automated 3CP® centrifuge, received US FDA 510(k) clearance in 2017 to be put on the market in the US as the 3C Patch System®. The indication for use is topical application, under the supervision of a healthcare professional, for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers, and mechanically or surgically-debrided wounds. In Europe, this technology has so far been made available under the name, LeucoPatch®.
Using a disposable procedure pack and the proprietary simple to use 3CP® process, a small ‘patch’ is produced at the point of care from the patient’s blood with no reagents or additives. The technology is currently being used at selected centres across Europe and has been evaluated for the treatment of non-healing diabetic foot ulcers in large a randomized controlled clinical study, that has now reported and confirmed significantly improved healing versus usual care.
Diabetic foot ulcers are associated with high morbidity and substantial health care costs as up to 40% of diabetic foot ulcer wounds remain unhealed after one year using current standards of care. Given these market dynamics, there is a clear need for an efficacious and cost-effective treatment option.
Reapplix ApS is a privately-held wound care company backed by three leading Danish investors, Seed Capital, Novo SEEDS and Vækstfonden (The Danish Growth Fund).

Contact

Reapplix ApS
Graeme Brookes, Chief Executive Officer
+45 53777447
gnb@reapplix.com

Instinctif Partners
Melanie Toyne Sewell / Rozi Morris
+44 20 7457 2020
Melanie.Toyne-Sewell@instinctif.com
Rozi.Morris@instinctif.com

Multiple SelectMDx Clinical Study Abstracts presented at 2018 Global Prostate Congress in Frankfurt, Germany

Herstal, Belgium and Irvine, CA, USA, June 27, 2018 / B3C newswire / --MDxHealth SA (Euronext Brussels: MDXH.BR), today announced the publication of positive data demonstrating the value of the SelectMDx liquid biopsy test for Prostate Cancer in guiding  patient management for men being considered for multiparametric MRI and the clinical utility in guiding biopsy decisions in real-world clinical practice. Data will be presented at the sixth Global Congress on Prostate Cancer (PROSCA) in Frankfurt, Germany, June 28-30, 2018.  

The data will be presented by researchers from Belgium and The Netherlands and are the first demonstration of SelectMDx for Prostate Cancer for guiding multiparametric MRI inclusion.

Assessment of a urinary TRUS/biomarker-based risk score as inclusion criteria for multiparametric MRI to detect clinically significant prostate cancer
Non-invasive techniques like SelectMDx and Magnetic Resonance Imaging (MRI) show great promise for the detection of prostate cancers that are clinically significant, avoiding over-diagnosis and over-treatment of cancers with low malignant potential. Although several studies support the promise of MRI in this arena, there remains a lack of consensus of its diagnostic accuracy, and its adoption faces further challenges due to the high cost of setting up, staffing and maintaining an MRI unit. Upfront risk stratification could significantly lower the cost of multiparametric MRI (mpMRI) by excluding patients who are at very low risk for high grade prostate cancer.

The study demonstrated that use of the SelectMDx liquid biopsy test for Prostate Cancer significantly reduces over-diagnosis and over-treatment, helping to identify patients who may forgo unnecessary MRI procedures.

The abstract can be found here.

Dr. Jan Groen, Chief Executive Officer of MDxHealth,commented: “These new studies show the clinical utility of SelectMDx for biopsy decision-making in real-world clinical practice. Significant results from multiple prior and ongoing studies on thousands of patients continue to support the value of SelectMDx as a tool to prevent unnecessary biopsy procedures in men demonstrating prostate cancer symptoms, benefiting patients and reducing the cost of public healthcare.”  

Professor Christopher Eden, Professor of Urology at The Royal Surrey County Hospital and Director of the Santis prostate cancer clinic in London, commented: “The use of genomic classifiers such as SelectMDx is set to revolutionise the way that we manage patients with prostate cancer, predicting with extreme accurately the likely biopsy findings and allowing us to tailor our advice and investigations appropriately.”

In addition to the above study the following abstracts will also be presented at PROSCA:

SelectMDx Impacts Prostate Biopsy Decision Making in Routine Clinical Practice
The study was conducted at five U.S. community urology practices, which sequentially enrolled 418 patients who received a SelectMDx test while undergoing consideration for an initial prostate biopsy. SelectMDx tests were ordered by the treating urologist for patient management (i.e., not as part of a planned or ongoing study), therefore reflecting real-world utility.

The study showed that SelectMDx had a significant impact on initial prostate biopsy decision-making in a U.S. community urology setting. Biopsy rates in men testing positive with SelectMDx were 5-fold higher than in men testing negative with SelectMDx. In the subset of patients biopsied within 3 months of receiving test results, 19/27 biopsies performed on SelectMDx positive men were cancer positive, including 10 with high grade disease. In SelectMDx negative men, cancers were identified in 4/9 men biopsied, and all were low-grade disease.

The abstract of the full study, SelectMDx Impacts Prostate Biopsy Decision Making in Routine Clinical Practice, can be found here.

Robust performance of a Urinary Molecular Biomarker–Based Risk Score to detect High-grade Prostate Cancer using optimised cascading models
The SelectMDx test results incorporate certain identified key clinical variables to improve the identification of patients at increased risk for high-grade PCa on prostate biopsy. The study demonstrates that, even in circumstances where not all clinical factors are available, the performance of SelectMDx remains robust, maintaining a >95% sensitivity.

The abstract can be found here.

 
About MDxHealth
MDxHealth is a multinational healthcare company, listed at the Brussels, Belgium, stock exchange (Euronext Brussels: MDXH.BR), that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy.

The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

Contacts

MDxHealth
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com

Consilium Strategic Communications (IR & PR)
Amber Fennell, Chris Welsh & Hendrik Thys
+44 20 3709 5701
mdxhealth@consilium-comms.com  
www.consilium-comms.com

LifeSpring Life Sciences Communication
Leon Melens
+31 6 538 16 427
lmelens@lifespring.nl

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.  This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx, InformMDx, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.

Basel, Switzerland, June 28, 2018 / B3C newswire / --NBE Therapeutics AG, a biopharmaceutical company developing next-generation antibody-drug conjugates (ADCs) for improved cancer therapy, today announces a CHF 20 million extension of the Series B round. Together with an earlier CHF 20 million series B financing, led by PPF Capital Partners Fund (PPF) with the participation of the Boehringer Ingelheim Venture Fund (BIVF) and private investors, the total series B financing round of NBE-Therapeutics has reached CHF 40 million. Novo Holdings becomes a major shareholder of NBE Therapeutics, alongside BIVF and PPF. The additional financing will allow NBE to advance the lead program NBE-002 targeting ROR-1 primarily for the treatment of solid tumors into clinical development and additional ADC pipeline programs through early development.

NBE develops next-generation ADCs based on its proprietary site-specific SMAC-conjugation™ technology and a novel ultra-potent anthracycline-based toxin platform with the objective to develop first- and best-in-class ADC product candidates against tumor targets in cancer indications of high, unmet medical need.   

Dr. Ulf Grawunder, CEO of NBE Therapeutics commented:“The additional investment by Novo into NBE-Therapeutics, represents another strong endorsement of our ADC platform, our team and our strategy for developing promising ADC product candidates for the benefit of cancer patients.” He continues: “We are particularly excited that Novo Holdings, with its outstanding track record and reputation in the field of life-science investments, has become a major shareholder of NBE-Therapeutics.”

As part of the transaction, Dr. Nanna Lüneborg, partner in the Novo Ventures team of Novo Holdings, has joined the Board of Directors of NBE-Therapeutics.

Theo Walthie, Chairman of NBE-Therapeutics welcomes Nanna Lüneborg and Novo Holdings as new partners of NBE Therapeutics and adds: “This is another important milestone in the development of NBE Therapeutics toward a clinical-stage ADC company. With the strong backing of three institutional investors, Novo, BIVF and PPF, and dedicated private investors, we are looking forward to advancing NBE-Therapeutics’ lead ADC program, NBE-002, into the clinic.”

Dr. Nanna Lüneborg comments:“We are excited to become shareholders of NBE-Therapeutics, and we look forward to working with the team and the Board to develop novel ADCs for the benefit of cancer patients in need of better targeted therapies.”

 
About NBE Therapeutics AG
NBE-Therapeutics is a privately owned Swiss, Basel-based biotech company, founded in 2012 with the vision to develop next-generation ADC products. The products will be advanced to clinical proof of concept with the goal of improving treatment options for cancer patients. The company leverages proprietary platforms covering all aspects of ADC development: its patented Transpo-mAb Display^TM technology for antibody discovery, patent pending SMAC-Technology^TM for site-specific payload conjugation of toxins to antibodies and a novel ultra-potent anthracycline-based toxin platform. The company is financially backed by Novo Holdings, the Boehringer Ingelheim Venture Fund, the PPF Capital Partners Fund and additional private investors.

About Novo Holdings A/S
Novo Holdings is a Danish private limited liability company wholly owned by the Novo Nordisk Foundation. Established in 1999, Novo Holdings is the holding company of the Novo Group and manages the Foundation's investment assets.

In addition to being the major shareholder in the Novo Group companies, Novo Holdings invests the wealth of the Foundation in two key categories: 1. Life Science Investments, which includes investing in life science companies at all stages of development; and 2. Financial Investments, which manages a diversified portfolio of equity and fixed income securities. Working out of Copenhagen, San Francisco and Boston, Novo Holdings is a world-leading life science investor with a focus on creating long-term value.

The purpose of the investments of Novo Holdings is both to grow the assets of the Foundation and to deliver a return that the Foundation can distribute for scientific, social and humanitarian purposes to improve the health and welfare of people.

About Boehringer Ingelheim Venture Fund GmbH 
The Boehringer Ingelheim Venture Fund (BIVF) was formed in March 2010 to invest in biotechnology and start-up companies to help drive innovation in medical science. The investment focus includes - but is not limited to immunomodulation, esp. immuno-oncology, tissue regeneration, new therapeutic modalities, e.g. gene therapy, cell-based therapeutics, ADC, and microbiome. These reflect BIVF’s interest in platform technologies and the extension of the current therapeutic area focus of Boehringer Ingelheim (BI) and demonstrate BIVF’s commitment to investigate new treatment modalities and technologies, beyond BI’s existing landscape, for the potential future benefit of patients. BIVF takes an active role with its portfolio companies – delivering significant added value through its own extensive drug discovery, scientific and managerial expertise. The BIVF has €250 million under management and supervises currently a portfolio of 23 active companies.”

About PPF
PPF Capital Partner Fund belongs to the PPF Group, which invests into multiple market segments such as banking and financial services, telecommunications, biotechnology, real estate, retail, insurance and agriculture. PPF’s reach spans from Europe to Russia, the USA and across Asia. PPF Group owns assets exceeding EUR 38 billion (as at 31 December 2017). 

 
Contact

Ulf Grawunder
CEO, NBE Therapeutics AG
+41 61 633 2230
ulf.grawunder@nbe-therapeutics.com

Singapore, June 28, 2018 / B3C newswire / --Prestige BioPharma and Alvogen today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar (HD201; Hervelous™) in Central and Eastern Europe.

Hervelous™ is a mAb biosimilar to Roche’s Herceptin® (trastuzumab), which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Hervelous™ is in Phase-3 clinical development for filing with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2019.

The partnership arrangement includes the exclusive rights for Alvogen to commercialize Hervelous™ (trastuzumab) in all of its CEE markets, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for full development, product registration with EMA, and commercial supply of Hervelous™, out of its manufacturing facilities in Osong, Korea.

Lisa S. Park, CEO of Prestige BioPharma, commented: “We are pleased to partner with Alvogen to commercialize our lead biosimilar program in Central and Eastern Europe. It is an important step towards our mission to become a leading global biosimilars and biopharmaceuticals development company.“

Hacho Hatchikian, Executive Vice President of Alvogen CEE, commented: "I am pleased to partner with Prestige BioPharma to further expand our biosimilar portfolio in the region. Alvogen is poised to capitalize on the biosimilar opportunities, with a 450-people-strong sales & marketing network covering over 20 CEE markets. We have managed to secure a leading position in biosimilars in the region, with a robust portfolio of leading molecules for the treatment of oncology, rheumatoid arthritis and anemia and the expected addition of Trastuzumab biosimilar (HD201; Hervelous™) will be a great addition to our biosimilar assets.“

 
About Prestige BioPharma
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on development of biosimilars and new antibody therapeutics. Its lead program, Hervelous™, is under Phase 3 clinical development. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase 1, and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages.

Manufacturing facilities for global commercial supply are located in Osong, Korea.

About Alvogen
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world.  The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan.

North America is Alvogen’s single largest market and other key markets include: South Korea, Russia, Romania, Hungary, Ukraine, Taiwan, Japan and China.

Contact

Ms. Felicia Ang
Global Communication Team
Prestige BioPharma
www.prestigebiopharma.com
+65-6924-6535
info@pbpsg.com

Boston, Mass, USA and London, UK, June 29, 2018 / B3C newswire / --Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the appointment of Jim Geraghty as chairman of its board of directors. Ben Auspitz, a partner at F-Prime Capital, who served as Orchard’s chairman since 2016, will transition from his current role on the board.

“Orchard is privileged to have Jim join its board of directors at this crucial phase in the company’s lifecycle, given his unique experience and insights in building a global organization over the long-term,” said Ben Auspitz.“At Genzyme, Jim played an important role in the company’s transformation from a start-up with a strong technology base in the 1980s to a leading global rare disease company. Orchard has the potential to undergo a similar transformation as a leader of the gene therapy revolution and will greatly benefit from Jim’s experience.”

Jim Geraghty is an industry leader with over 30 years of strategic experience including more than 20 years as a senior executive at biotechnology companies developing and commercializing innovative therapies. Over his career, Jim served as senior vice president, North America strategy and business development at Sanofi, and previously as senior vice president international development at Genzyme, president of Genzyme Europe, and founding president and CEO of Genzyme Transgenics. Mr. Geraghty is chairman for the boards of Idera, Pieris and Juniper Pharmaceuticals, and is a member of the board of Voyager Therapeutics. He was most recently an entrepreneur in residence at Third Rock Ventures. Mr. Geraghty started his career in healthcare strategy consulting at Bain. A graduate of Yale Law School, Mr. Geraghty also holds a Master of Science degree from the University of Pennsylvania and a Bachelor of Arts degree from Georgetown University.

Jim Geraghty commented,“I am excited to be joining Orchard Therapeutics, an emerging leader in gene therapy for rare diseases. The company’s autologous ex vivo gene therapy technology is poised to change the practice of medicine across many indications, and I look forward to working with the executive team and other board members to help Orchard build a leadership position in the research, development and commercialization of gene therapies.”

Mark Rothera, Orchard’s president and CEO stated,“We are delighted to welcome Jim as chair of our board of directors. Jim’s advice and leadership will be invaluable as we continue to make progress towards being a global, fully integrated company transforming the lives of patients with rare diseases through gene therapy. I would also like to thank Ben for his commitment and guidance since the company’s formation. His insights have been a key ingredient of our success during our formative years and through our previous financing rounds.”

 
About Orchard
Orchard Therapeutics is a leading global fully integrated commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Evolved from over 20 years of academic research, Orchard has developed a unique expertise in the manufacturing, preclinical and clinical development of gene therapies for rare diseases. To date, more than 130 patients have been treated with autologous ex vivo gene therapy across five different disease areas, with evidence of sustained clinical effects up to 17 years post treatment in some patients. The company’s most advanced clinical program, OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency), is expected to progress to a BLA (biological license application) with the FDA in 2018.

Orchard’s portfolio of autologous ex vivo gene therapy programs include Strimvelis, the first autologous ex vivo gene therapy approved by the EMA in 2016, three programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott–Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

The company is 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, Boston Children’s Hospital, and Telethon Institute for Gene Therapy/Ospedale San Raffaele.

Orchard is privately held with offices in the UK and the US, including London, San Francisco and Boston. The company raised $110 million in a Series B in December 2017, was named a Fierce 15 Company by FierceBiotech in 2016 and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM).

 
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

York, UK, June 29, 2018 / B3C newswire / -- Rapidly growing biotech business, Aptamer Group Ltd, has closed its Series A investment round after attracting international interest, securing $2.2m of funding from overseas investors to support its pioneering aptamer development programme.

The funding will enable the expansion of the York Science Park-based business, creating ten new positions in technical, sales and administration roles which will support its continuous growth.

The Company is a key player in the global aptamer market, specialising in identification, development and characterisation of nucleic acid aptamers - a synthetic alternative to antibodies - which are fast becoming alternatives to traditional antibody approaches – replacing or filling the current gap in the antibody market.

Aptamer Group was founded in 2008 by Chief Executive Officer, Dr Arron Tolley and Chief Technical Officer, Dr David Bunka, who lead the now 16-strong team serving a global customer base of more than 50 organisations and has several of the top ten global Pharma companies as its customer base. The business operates four separate companies under the Aptamer Group ‘umbrella’ and has recently added an office in Boston (United States) where the aptamer market is growing rapidly.

Chief Executive Officer, Dr Arron Tolley says: “Aptamer technology is rapidly evolving and will have a significant effect on the life sciences market in the coming years due to our ability to rapidly discover aptamers - combined with advantages in the manufacturing process such as the stability of aptamers, the cost of manufacturing and the reproducibility of results when compared to antibodies. The investment will allow us to drive forward our pre-clinical discovery programmes involving the development of aptamer drug conjugates (ApDCs) which are set to become a revolutionary approach to targeted drug delivery.”

The funding round was supported by Netherlands-based biopharmaceutical investment company, Meneldor - founded by Dutch entrepreneurs Frans van Dalen and Paul Lelieveld. Frans is a founding partner of Synthon Holdings and has 30 years' experience in the development of New Biological Entities (NBEs) and Biosimilars. Paul is a serial investor and has invested in numerous early-stage life-science companies including Ablynx, which recently sold to Sanofi for $4.8bn.

Says Meneldor: “We believe that aptamer technology represents a paradigm shift in drug delivery methodology. We have invested in Aptamer Group Ltd due to their progressive approach and unique technology platform, which can select aptamers significantly better and faster with the superior binding properties.

We believe that this will lead to the development of new medicines and represents an exciting investment opportunity. We believe this company and its management team has the potential of becoming the next Ablynx”.

 
Contact

Hannah Trinder
The Partners Group
+44 (0)1904 610077
hannah@partners-group.co.uk

Clone 73-10 now available to the global research community

Cambridge, UK, July 02, 2018 / B3C newswire / --Abcam, a global innovator in life science reagents and tools today announced the commercial launch of the new anti-PD-L1 antibody clone MKP1A07310 (clone 73-10) developed in collaboration with Merck KGaA, Darmstadt, Germany.

Developed by Abcam for use by Merck as an analytical antibody to support Merck’s therapeutic programme several years ago, this new clone has been created by Abcam’s in-house antibody engineers, who specialise in the discovery and development of challenging antibodies. The antibody is important in assessing the expression of PD-L1 in tumors from patients who might be able to benefit from PD-1/PD-L1 checkpoint immunotherapy.

John Baker, SVP Portfolio and Business Development, Abcam said:“Collaborations with industry partners are an important part of Abcam’s strategy to provide the best tools to all researchers world-wide. By working with Merck we are able to make available this important antibody at scale to help scientists accelerate their research, and expand understanding of the role of immune checkpoint inhibitors as cancer therapeutics.”

Clone 73-10 is an important addition to Abcam’s range of PD-1/PD-L1 immune checkpoint antibodies and is available via the Abcam website. To find out more please visit www.abcam.com/pdl1-ab-73-10.

About Abcam
As an innovator in reagents and tools, Abcam’s purpose is to serve life science researchers globally to achieve their mission, faster. Providing the research and clinical communities with tools and scientific support, the Company offers highly validated biological binders and assays to address important targets in critical biological pathways.

Already a pioneer in data sharing and ecommerce in the life sciences, Abcam’s ambition is to be the most influential company in life sciences by helping advance global understanding of biology and causes of disease, which, in turn, will drive new treatments and improved health.

Two-thirds of the world’s 750,000 life science researchers use Abcam’s affinity binders, reagents, biomarkers and assays and the Company’s products are mentioned in over 20,000 of the 56,000 peer-reviewed papers published each year in the life sciences.

By actively listening to and collaborating with researchers, the Company continuously advances its portfolio to address their needs. A transparent programme of customer reviews and datasheets, combined with an industry-leading validation initiative, gives researchers increased confidence in their results.

Abcam’s eleven locations are in the world’s leading life science research hubs, enabling local services and multi-language support. Founded in 1998 and headquartered in Cambridge, UK, the Company sells to more than 100 countries. Abcam was admitted to AIM in 2005 (AIM: ABC).

Contacts

Abcam
Francesca Axe
+44 1223 696000

Media enquiries
Dr. Lynne Trowbridge / Tim Watson, Instinctif Partners
+44 20 7866 7861
abcam@instinctif.com

Funding enables clinical stage trials of lead compound PseudoXa

• € 7.5 million Series A financing from lead investor BioGeneration Ventures (BGV) and Dutch regional development companyInnovationQuarter
• Financing supplemented by € 5.0 million innovation credit from the Netherlands Enterprise Agency (RVO.nl)
• Leading compound addresses high unmet need for effective prevention and treatment of severe bleeding in the growing number of patients taking anti-coagulants
• Funding enables VarmX to significantly speed up the development of the lead compound and progress to clinical trials.

Leiden, The Netherlands, July 02, 2018 / B3C newswire / --VarmX, Leiden based biotech company focusing on the development of therapies in the field of hemostasis and thrombosis, today announced the closing of a Series A financing round of € 7.5 million. The round was led by the existing shareholder BioGeneration Ventures (BGV) and regional economic development company InnovationQuarter also invested. Uniiq and Leiden University are also shareholders through conversion of their start-up loan to the company. The equity financing is supplemented by the Netherlands Enterprise Agency (RVO.nl) with an Innovation Credit of € 5.0 million to a total of € 12.5 million. The series A round is a follow up to the initial seed financing in June 2017 by BGV and Innovation Quarter. This news was announced this weekend at HollandBIO’s Dutch Biotech Event.

VarmX is developing lead compound PseudoXa to stop or prevent bleeding in patients taking anti-coagulants in the form of synthetic factor Xa inhibitors.  The product is based on the innovative research into the properties of a snake venom and of human factor X performed at the Leiden University Medical Center (LUMC). The new financing will enable VarmX to advance its lead compound PseudoXa as a safe and effective factor Xa anti-coagulant reversal agent into human clinical studies.

To avoid stroke or deep vein thrombosis, millions of patients worldwide daily take synthetic factor Xa inhibitors, such as apixaban, edoxaban or rivaroxaban, and the use of these drugs is increasing rapidly. As a side-effect, each year 2-3 % of patients taking these anti-coagulant drugs experience severe (internal) bleeding which is difficult to treat or to prevent in the setting of emergency surgery. PseudoXa offers a safe and effective solution to this bleeding problem by its capacity to immediately restore blood coagulation in the presence of factor Xa anti-coagulants.

Investors

With their Series A investment, following last year’s seed investment, BGV and InnovationQuarter together with RVO.nl enable the company expand its team and develop the production process, focusing on purification and formulation as well as on the pharmacodynamics and kinetics of the active compound. Moreover, safety in preclinical models and in human volunteers will be demonstrated. Work will also continue on the development of new compounds, to build VarmX into a biotechnology company with a broader pipeline of hemostasis and thrombosis related therapies.

Paul Bilars, CEO of VarmX and Professor Pieter Reitsma, emeritus of Molecular and Experimental Medicine at LUMC and CSO of VarmX, are excited about the prospect of bringing this drug to the market: “We are delighted with the trust of our shareholders, and also with the support that RVO.nl provides for our groundbreaking innovation. This meaningful funding allows VarmX to accelerate the development of PseudoXa and thus achieve our ultimate goal: to get our leading therapy treating severe bleeding in patients using anti-coagulants to the patient as quickly as possible. Our innovation is an important solution for another unmet medical need with which we try to make a difference for patients and their quality of life.”

Francis Quint, Head of InnovationQuarter Capital, states: “We are very satisfied with the good results VarmX reached during the last year and are pleased to again support this LUMC spin off to bring the development of PseudoXa to the next phase, the first clinical trials. Together with BGV and RVO we can give VarmX the opportunity to fully focus on the development of their promising compound, that address the significant unmet needs in the field of anti-coagulants.”

Oskar Slotboom, partner at BGV and chairman of VarmX comments:“We are pleased to lead this investment round to enable VarmX to demonstrate the safety and effectiveness of PseudoXa in clinical trials. Addressing such an unmet need for patients by applying differentiating innovative approaches is at the center of BGV’s investment strategy.”

Caption: VarmX's CEO Paul Bilars (middle left) and CSO Prof. Pieter Reitsma (middle right) show the tumbstone for their new €12.5 mln financing at the HollandBIO Dutch Biotech Event this weekend. On their left side from left to right presenter Hans Schikan, René Brama and Gerty Holla (InnvovationQuarter) and to the right, Francis Quint (InnovationQuarter), Elisabeth Schless of Rvo and Colja Laane on behalf of InnovationQuarter. 
Photo: Nils van Houts

For high resolution please click the image.

 
About VarmX
VarmX is a pharmaceutical spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. CEO is Paul Bilars, former managing director of one of LUMC’s divisions. In this capacity, he was also responsible for valorization of IP and strategic sourcing.
Product development is based on R&D performed by one of the world’s leading groups in hemostasis and thrombosis at the Leiden University Medical Center (LUMC), led by professor Reitsma.

The company’s leading product in development, PseudoXa, is a new therapeutic protein, based on the innovative research into the properties of a snake venom, to prevent or stop severe bleeding in patients taking factor Xa inhibitors, such as the commonly used apixaban.

About BioGeneration Ventures (BGV)
BioGeneration Ventures (BGV) is a specialist life sciences venture capital firm, with a focus on early stage European biotech, medtech, and diagnostics companies. BGV has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class teams. BGV manages funds investing in areas where the science, the unmet medical need, and the potential to promptly demonstrate a significant proof of concept all come together.
Successful investments include divestment of Dezima Pharma to Amgen for up to USD 1.55 billion in total deal value and in Acerta Pharma for up to USD 7 billion with a guaranteed payment of USD 4 billion. In both companies BGV was founding investor. The Acerta Pharma sale was the largest exit ever of a privately held European biotech company. Over the last decade BGV has made over 20 investments.
BGV is based in Naarden, The Netherlands, and closely collaborates with Forbion.

About InnovationQuarter
InnovationQuarter is the regional 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.

InnovationQuarter Capital - which currently consists of € 135 million committed capital - offers venture capital to young technology companies and SMEs with growth plans in the region to bring new innovations to market. Through the fund, InnovationQuarter can raise the regional economy to a higher level.

InnovationQuarter is an initiative of the Ministry of Economic Affairs, the Province of South Holland, the Cities of Rotterdam, The Hague, Leiden, Delft, Drechtsteden, Westland and Zoetermeer, Delft University of Technology (TU Delft), Leiden University, the Leiden University Medical Center and Erasmus Medical Centre and Foundation HEID (Holding Fund for Economic Investment The Hague).

About UNIIQ
UNIIQ is a € 22 million investment fund investing in the proof-of-concept phase in innovative (bio)technology companies which are located in the South-Holland province. UNIIQ offers seed capital to entrepreneurs, offering them the capital for technology- and market validation and fund the initial high-risk proof-of-concept phase.

The fund is founded by Erasmus University Medical Center, Delft University of Technology, Leiden University and regional development agency InnovationQuarter. UNIIQ is supported by the European Union, the province of South-Holland and the municipalities of Rotterdam, The Hague and Leiden. InnovationQuarter performs the Fund management for UNIIQ.

 
Contacts

VarmX
Paul Bilars, CEO VarmX B.V.
T: +31715156127
M: +31610202593
p.bilars@varmx.com
www.varmx.com

Pieter Reitsma, CSO VarmX B.V.
T: +31715156127
M: +31651028841
p.h.reitsma@varmx.com

For media inquiries
LifeSpring Life Sciences & Health Communications, Amsterdam
Leon Melens
+31 6 538 16427
lmelens@lifespring.nl

Boston, USA and London, UK, July 09, 2018 / B3C newswire / --Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today announced the appointment of Joanne Beck, Ph.D., to its board of directors. Dr. Beck is currently the executive vice president of pharmaceutical development and operations and a member of the executive committee at Celgene.

Mark Rothera, president and CEO of Orchard said,“We are thrilled to have Joanne join our board. Her extensive experience in pharmaceutical development, global manufacturing operations and quality will serve our company very well as we accelerate our plans to implement a global supply chain of transformative gene therapies.”

Prior to Celgene, Dr. Beck was senior vice president of pharmaceutical development at Shire from 2012 to 2016. Before Shire, she held various leadership positions in Abbott’s global pharmaceutical operations and was the site head of Abbott Vascular Instruments GmbH. Earlier in her career, Dr. Beck held positions in process development at Genentech and Amgen. She holds a Bachelor of Arts degree from Lewis and Clark College and a Ph.D. from the University of Oregon Medical School.                                                                                                   

Dr. Beck commented,“I am pleased to be joining Orchard’s board of directors at such a pivotal time in the company’s development. I look forward to working with the board and leadership team as Orchard implements a global supply chain that delivers personalized gene therapies to patients.”

 
About Orchard
Orchard Therapeutics is a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Evolved from over 20 years of academic research, Orchard has developed a unique expertise in the manufacturing, preclinical and clinical development of gene therapies for rare diseases. To date, more than 130 patients have been treated with autologous ex vivo gene therapy across five different disease areas, with evidence of sustained clinical effects up to 17 years post treatment in some patients. The company’s most advanced clinical program, OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency), is expected to progress to a BLA (biological license application) with the FDA in 2018.

Orchard’s portfolio of autologous ex vivo gene therapy programs include Strimvelis, the first autologous ex vivo gene therapy approved by the EMA in 2016, three programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott–Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

The company is 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, Boston Children’s Hospital, and Telethon Institute for Gene Therapy/Ospedale San Raffaele.

Orchard is privately held with offices in the UK and the US, including London, San Francisco and Boston. The company raised $110 million in a Series B in December 2017, was named a Fierce 15 Company by FierceBiotech in 2016 and was awarded a $19 million grant from the California Institute of Regenerative Medicine (CIRM).

 
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

Berlin, Germany, and San Francisco, CA, USA, July 10, 2018 / B3C newswire / --ProBioGen AG, a premier service and technology provider for complex therapeutic glycoproteins, and Pionyr Immunotherapeutics, an immuno-oncology company which develops next generation antibody-based therapeutics that target the tumor microenvironment, today announced a second service and license agreement to develop novel antibody therapeutics. Under the terms of the agreement, ProBioGen will perform process development and GMP manufacturing on a second antibody from the Pionyr pipeline using their high performance CHO.RiGHT® expression platform. Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline, enabling a rapid advance to clinical trials.

“We developed a strong collaboration with Pionyr Immunotherapeutics on their initial antibody candidate, and we are enthusiastic about advancing a second antibody candidate into development. We consider Pionyr’s Myeloid Tuning™ approach to be ideally suited to target solid tumors and look forward to contributing to multiple programs with our CHO.RiGHT® development and manufacturing platform. We have established a seamless team working across the two companies and are very pleased to expand our collaboration”, said Dr René Brecht, VP Process Science and Manufacturing.

Evan Greger, Pionyr VP of Process Development and CMC, added,“Pionyr is developing a novel class of antibody-based therapeutics that can alter the tumor microenvironment to favor immune-activating cells over immune-suppressing cells. After establishing a collaboration with ProBioGen in 2017 to advance our first Myeloid Tuning™ candidate into cell line development and clinical trials, we are enthusiastic to continue our partnership and advance a second antibody candidate. ProBioGen is an outstanding partner with well-respected development and manufacturing services. The CHO.RiGHT® expression platform, combined with their experienced, committed team, is ideally suited for the rapid and successful advancement of our antibody programs into clinical trials.”

 
About ProBioGen AG
ProBioGen is a premier, Berlin-based specialist for development and manufacturing of complex therapeutic glycoproteins. Combining both state-of-the-art development platforms, based on its 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 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 in 1994, is privately owned, and is located in Berlin, Germany.

About Pionyr Immunotherapeutics Inc.
Pionyr Immunotherapeutics (formerly Precision Immune Inc.), located in San Francisco, California, USA, is developing cancer immunotherapies that target the tumor microenvironment to enhance the body's antitumor immunity. The company is exploiting novel target discovery and antibody generation platform technologies to create a next generation of immuno-oncology therapeutics. The company's approach, Myeloid Tuning™, is designed to enhance the immune system's anti-tumor response by altering the cellular infiltrate of the tumor microenvironment with high specificity. Pionyr’s Myeloid Tuning™ technology is based on the discovery that altering the tumor microenvironment to favor immune-activating cells over immune-suppressing cells enhances the body’s ability to combat cancer.

 
Contacts

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

Pionyr Immunotherapeutics
Evan Greger
Vice President, Process Development and CMC
Pionyr Immunotherapeutics Inc.
953 Indiana Street
San Francisco, CA 94107
+1 415 226 7503
info@pionyrtx.com
www.pionyrtx.com

• Immatics and Genmab to Combine Proprietary Technologies to Create Transformative Bispecific Therapies against Novel, Proprietary Tumor Targets
• Immatics to Receive $54 Million Upfront, Milestone Payments Plus Royalties and an Option to Co-Promote the Partnership Products

Tuebingen, Germany, July 12, 2018 / B3C newswire / --Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, announced today that it has entered into a research collaboration and license agreement with Genmab A/S (Nasdaq Copenhagen: GEN) to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications.

The companies will conduct joint research, funded by Genmab, to combine Immatics’ XPRESIDENT® and Bispecific TCR technology platforms with Genmab’s proprietary antibody technologies to develop multiple bispecific immunotherapies in oncology. The companies will exclusively discover and develop immunotherapies directed against three proprietary targets, which were discovered and developed by Immatics’ XPRESIDENT® technology. Genmab has the option to exclusively license up to two additional targets to expand the partnership at predetermined economics.

Genmab will be responsible for development, manufacturing and worldwide commercialization. Immatics will have an option to contribute certain promotion efforts at predetermined levels in selected countries in the EU.

Under the terms of the agreement, Immatics will receive an upfront fee of $54 million and is eligible to receive up to $550 million in development, regulatory and commercial milestone payments for each product and tiered royalties up to a double-digit percentage of net sales.

Carsten Reinhardt, M.D., Ph.D., Chief Medical Officer and Managing Director of Immatics, commented:“We are very pleased to join forces with one of the world-leading biotechnology companies to develop and advance novel and highly active cancer therapeutics. This collaboration underpins Immatics’ leadership in intracellular tumor target identification and T-cell receptor engineering.” Dr. Reinhardt further said: “Our bispecific TCR technology exhibits exceptional potency and favourable pharmacokinetic properties by combining Immatics’ proprietary T-cell engaging format with our high-affinity and highly specific T-cell receptors as reported at AACR 2018.(1)”

“This collaboration with Immatics gives us the opportunity to combine our unique technologies and expertise to create differentiated novel next-generation therapies. We very much look forward to this exciting partnership in the field of cancer immunotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Immatics’ Bispecific TCR Technology
Bispecific T-cell receptor (TCR) molecules are biologics that leverage the body’s immune system by redirecting and activating the T-cell response towards cancer cells expressing specific tumor targets. Immatics’ best-in-class bispecific TCR molecules are soluble fusion proteins that have two binding domains: an affinity-maturated and highly selective TCR domain that recognizes and binds to a tumor-specific peptide target presented in the context of HLA class I receptor, and a T-cell recruiting antibody domain directed against CD3 or other immuno-modulating T-cell surface proteins. The design of these novel biologics allows T cells to become activated and attack the tumor, regardless of the T cells’ intrinsic specificity.

About Immatics
Immatics is a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer. The Companies’ transformative product candidates are ‒ best in class ‒ Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics’ proprietary and world-leading XPRESIDENT® technology. XPRESIDENT® is the most sensitive, unbiased and high-throughput technology capable of identifying targets in virtually any type of cancer and any HLA type. Together with Immatics’ powerful TCR discovery technology, these two platforms allow a full range of cancer therapies to be developed.

Immatics’ pipeline includes T-cell therapy programs based on the proprietary ACTolog®, ACTengine® and ACTallo® approaches, which are developed in collaboration through Immatics US with University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT), and several bispecific TCR and antibody molecules.

Operating from Tuebingen, Munich and Houston, the Company has recognized that novel, better and safer targets are the key to developing future cancer immunotherapies and it is Immatics’ mission to deliver the power of T cells to cancer patients.

About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications and other blood cancers.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.

 
Contact

Immatics Biotechnologies GmbH
Dr. Nikola Wiegeler                                                                                                             
+49 7071 5397-110
media@immatics.com

(1)  Bunk S, et al. Development of highly potent T-cell receptor bispecifics with picomolar activity against tumor-specific HLA ligands [abstract]. In: Proceedings of the 109^th Annual Meeting of the American Association for Cancer Research; 2018 Apr 14–18; Chicago, IL. Abstract nr 2789.

New investors Omnes, BNP Paribas Développement and Sham Innovation Santé invest an additional €5.2M on top of the €7.3M first closing announced in October 2017

Labège, France, July 12, 2018 / B3C newswire / --Antabio SAS, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs, announced today it has extended its Series A financing round with an additional €5.2 million subscribed by investment funds Omnes, BNP Paribas Développement, and Sham Innovation Santé (Turenne Capital). Existing shareholder Galia Gestion also participated in this extension. In October 2017, Antabio announced a first closing of its Series A financing round for €7.3 million subscribed by investment funds iXO Private Equity, IRDI SORIDEC Gestion, Galia Gestion and Antabio’s historical investor and former President of OM Pharma Christophe Ricard. The second closing brings the total raised in Series A to €12.5 million.

The new funding will be used to accelerate the development of Antabio’s novel inhibitor of bacterial metallo ß-lactamases (“MBLs”) which will be combined with a carbapenem to fill an important gap in the treatment of drug-resistant infections. Superbugs carrying MBLs (such as NDM-1) are spreading worldwide and cause life-threatening drug-resistant infections that are deemed a critical medical priority by the WHO. There are currently no marketed inhibitors of MBLs.

The €12.5 million series A financing complements the CARB-X grant of up to $8.9 million awarded to Antabio in July 2017 to support the company’s Pseudomonas Elastase Inhibitor program (PEI) for the treatment of chronic Pseudomonas infections in Cystic Fibrosis patients.

“We are thrilled to welcome Omnes, BNP Paribas Développement, and Sham Innovation Santé to Antabio,” said Marc Lemonnier, CEO of Antabio.“We have built a strong international team of experts to combat the most urgent unmet medical needs in the antibacterial space. This extension to our series A, coupled with the substantial non-dilutive funding received from CARB-X, provides solid financial means for Antabio to take our innovative program into the clinic and move closer to this goal”.

Antibiotic resistance is a growing global health problem recognized as n°1 priority by the WHO. Today, 5 to 10% of hospital patients in the USA and Europe develop a hospital-acquired (nosocomial) infection with over 100,000 deaths due to drug-resistant bacterial infections per year and annual costs to public health exceeding €30 billion. On the horizon, alarming reports claim that by 2050 antimicrobial resistance will kill more people than cancer with an estimated 10 million people dying from resistant infections each year.

"Antibiotic resistance is one of the great challenges of our time. At Omnes, we were impressed by the innovative approach taken by the company to fight drug-resistant infections and we are delighted to support their strong international team to accelerate the development of their programs to the clinic" said Claire Poulard, Associate at Omnes.

About Omnes
Omnes is a leading Paris-based European investor in private equity and infrastructure. With €3.6 billion of assets under management, Omnes provides SMEs with the capital needed to finance growth. The firm has dedicated investment teams across three key areas: Venture Capital, Buyout & Growth Capital and Infrastructure. With more than 30 trade sales and nearly 15 IPOs in 19 years (including Novaled, Biovex, arGEN-X and Direct Energie), Omnes’ venture team is a leading French player in financing innovative SMEs with dual expertise in the deep-tech and healthcare sectors. Omnes is owned by its employees. Omnes is committed to ESG issues and has set up the Omnes Foundation in aid of children’s charities. It is also a signatory to the United Nations Principles for Responsible Investment (PRI). More information on www.omnescapital.com
Press contacts
Omnes Capital : Gaëlle de Montoussé, gaelle.demontousse@omnescapital.com– +33 1 80 48 79 16
Brackendale Consulting: Fay Margo, fay@brackendaleconsulting.com - +44 7962115825

About BNP Paribas Développement
BNP Paribas Développement, a BNP Paribas Group subsidiary founded in 1988, invests its own capital directly in promising small and medium-sized enterprises and mid-cap companies.  As a minority shareholder in these target companies, BNP Paribas Développement seeks to promote their growth and ensure their longer-term prosperity by facilitating ownership transfer.

In addition to providing financial resources so as to ensure the stability of any company in which BNP Paribas Développement invests, we also see our mission in helping the company management team to achieve its medium-term strategic plans.  As a minority shareholder, our approach is to assist our partner with an appropriate level of governance, based on our experience of managing a portfolio of some 300 company shareholdings and backed by the strength of a world-class financial group, but without interfering in the day-to-day running of the partner company.  Our policy of investing our own capital allows us to provide our partner companies with long-term backing suited to the nature of the particular business and its goals, and also enables us to act as an intermediary in such deals as capital re-organisations and external growth operations. In 2016, BNP Paribas Développement set up the WAI Venture Fund, which specialises in investing in Innovation-oriented companies, from the provision of seed capital through all subsequent funding rounds, with the aim of supporting the growth of high-potential startups.
Press contact: Olivier Durbize, olivier.durbize@bnpparibas.com - +33 1 40 14 66 28. More information on www.bnpparibasdeveloppement.com

About Sham Innovation Santé
Launched in July 2014, Sham Innovation Santé is an evergreen Venture Capital Fund controlled and owned by Sham, a French mutual insurance company specializing in insurance and risk management for professionals in the health, social and social-medical sectors and a French leader in civil liability (11,000 members in Europe – France, Italy, Spain, Germany –, € 2 billion in assets under management, 952 employees, revenues of € 438.2 million in 2018).
Advised and managed by Turenne Capital, Sham Innovation Santé invests into biotech and medtech companies that are developing breakthrough technologies in the medical and biotechnology fields. The portfolio – 12 companies – is being gradually built up by new investments in the healthcare and life sciences field, with a target of € 50 million.
Press contact: Josépha Montana, jmontana@turennecapital.com - +33 6 01 21 21 49. More information on  www.sham.fr |  www.turennecapital.com

About ANTABIO
Antabio is a private biopharmaceutical company developing novel antibacterial resistance-breakers to treat drug-resistant infections in areas of highest unmet medical need. Two of Antabio’s programs have received Wellcome Trust Seeding Drug Discovery Awards to date:(i) a novel, safe and efficacious inhibitor of bacterial metallo ß-lactamases to be combined with a carbapenem for the treatment of drug-resistant nosocomial infections and (ii) a first-in-class inhibitor of Pseudomonas virulence to be co-administered with standard-of-care antibiotics for the long-term management of chronic respiratory infections. This second program has recently received up to $8.9 million funding from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The company’s lead product is expected to enter the clinic in 2019 with anticipated fast track approval. Antabio has built a best in class, international team of experts in the field to progress its pipeline. The Company is in the process of acquiring additional assets focused on Gram-negative antibiotic resistant therapies.
Press contact: Carine Bonnet-Danaire, press@antabio.com - +33 5 31 47 18 57. More information on www.antabio.com and follow us on Twitter @antabio 

Munich, Germany, July 17, 2018 / B3C newswire / --leon-nanodrugs GmbH (“leon”) is pleased to announce that its proprietary MicroJet Reactor (MJR®) nano-technology has been selected by Takeda Pharmaceutical Company Ltd. (Takeda) for a feasibility assessment that could potentially lead to the development of an innovative formulation of one of their current pipeline products.

leon-nanodrugs announced that the company has started a feasibility assessment collaboration with Takeda. Under this collaboration, leon will support Takeda`s formulation efforts to optimize solubility, bioavailability and stability for one of Takeda’s current pipeline products for drug delivery using leon’s proprietary nanotechnology platform –MicroJet Reactor (MJR®).

leon`s platform can be used from early compound screening to production of market batches. Positive results from this feasibility study could potentially result in a long-term collaboration between the companies, and additional compounds may also be considered.

It is estimated that over 60% of pharmaceutical API’s are poorly soluble in water.  leon’s MJR technology offers reformulation options that not only address this issue, but can also lead to a superior profile for the API by increasing bioavailability, reducing inter patient variability, improving onset of action, etc. The one-step, bottom up, continuous precipitation process approach of the MJR® technology is cost effective and easily scalable.

Dr. Michael Mehler, CEO of leon-nanodrugs GmbH comments:“We are very pleased and proud that Takeda selected our MJR® technology for a feasibility assessment with one of their compounds in development. It is a major milestone for our company to win Takeda, a globally leading pharmaceutical company, as a partner and we look forward to this collaboration with the goal to contributing to bring valuable new medicines to patients worldwide.”

About leon
leon-nanodrugs GmbH (Munich) is a nanotechnology-based drug development company focused on reformulations to develop novel oral and parenteral formulations and innovative drug combinations. Build on its “network of expertise”, leon-nanodrugs can provide a 360 degree service range – from concept to product approval. By using MJR®-technology leon took the technical leadership in the re-formulation market and is creating patient benefits and economical values to existing drugs. leon works with its Pharma customers through contract development agreements, as well as co-development partnerships. leon has also initiated work on its own internal development projects, concentrating on nanotechnology-based reformulations that offer enhanced clinical and safety benefits.

Contact

Dr. Michael Mehler
Chief Executive Officer
leon-nanodrugs GmbH
Kopernikusstrasse 9
D-81679 München
m.mehler@leon-nanodrugs.com

Lausanne, Switzerland and Palo Alto, USA, July 17, 2018 / B3C newswire / --Polares Medical SA, a preclinical stage medical technology company focused on the development of a unique trans-catheter mitral valve hemi-replacement system to treat patients suffering from mitral regurgitation (MR), announced today the closing of a $25 million financing led by Decheng Capital (Menlo Park and Shanghai) together with Endeavour Vision (Geneva), IDO Investments (Muscat), Earlybird Venture Capital (Berlin) and Wellington Partners (Munich).

Polares Medical’s solution to MR is based on the original concept of hemi-replacement of the mitral valve, i.e. the replacement of the posterior leaflet with a prosthetic leaflet designed to enhance coaptation with the native anterior leaflet.

“Hemi-replacement represents a new treatment paradigm for mitral regurgitation, between repair and total replacement. We believe this approach has the potential to provide an effective addition to the armamentarium for the percutaneous treatment of MR,” said Decheng Principal Nick Pliam, MD, Ph.D.

Polares Medical was created as a spin-off of Symetis SA to develop the mitral technology that Symetis obtained through its acquisition of Middle Peak Medical GmbH, prior to Boston Scientific Corporation’s acquisition of Symetis in 2017. 

“This investment allows Polares to bring our technology to clinical evaluation, and to unleash its potential as a game-changer in MR treatment.” said Jacques Essinger, Ph.D, Chairman and CEO.

Contacts

Polares Medical SA
+41 21 310 11 20
info@polaresmedical.com
www.polaresmedical.com

Decheng
+1 (650) 233-0688
nick@decheng.com
www.decheng.com

Deqing, China, July 19, 2018 / B3C newswire / -- Following a 2016 accreditation of Shuwen Biotech’s central lab, Shuwen Guanz Diagnostic Lab Co., Ltd, Shuwen is proud to announce that it has successfully passed the 2018 biannual review and was awarded a two-year extension of the CAP accreditation.

Certification from The College of American Pathologists (CAP) is recognized as the global standard for laboratory quality management and technology in various international medical organizations, and has become the "gold standard" in the field of international laboratory medicine. Reports issued by CAP-certified laboratories meet US FDA requirements in the regulatory processes for new drugs to be marketed in the United States.

About Shuwen Biotech
Shuwen Biotech is a China-based diagnostic company founded on the principles of innovation, patent protection, and international collaboration as its strategic platforms for growth. Since 2011, Shuwen established strategic partnerships with numerous outstanding academic and commercial institutions such as Yale University, University of Chicago, BioNTech, Sphingotec among others in the form of exclusive licensing of first-in-class diagnostic technologies and patents covering a range of novel biomarkers for companion diagnostics and other diagnostics in the fields of cancer, women’s health, critical care, and health screening and other fields. Shuwen has also developed innovative and quality companion diagnostics and provided central lab testing services to leading pharmaceutical developers. Shuwen houses an in-house development team, CAP-accredited central labs, and ISO13485-certified IVD manufacturing facilities, all in line with global standards in order to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health.

Contact

Vafa Amirkia
bd@shuwendx.cn

Santa Monica, USA and Utrecht, the Netherlands, July 19, 2018 / B3C newswire / -- Kite, a Gilead Company (Nasdaq: GILD), and Gadeta B.V., a privately-held company focused on the discovery and development of novel cancer immunotherapies based on gamma delta T cell receptors (TCRs), have entered into a strategic collaboration to develop novel gamma delta TCR therapies in various cancers. Under the financial terms, Kite will provide research and development (R&D) funding for the collaboration and Gadeta will be eligible to receive future payments upon achievement of certain regulatory milestones.  In addition, Kite will make an upfront purchase of equity in Gadeta from Gadeta’s shareholders and may acquire additional equity in Gadeta upon achievement of certain R&D milestones. Kite will have the exclusive option to acquire Gadeta.

Gadeta has developed a proprietary technology to engineer alpha beta T cells with gamma delta TCRs, called TEGs, for the potential treatment of various hematological cancers and solid tumors. This platform has the potential to combine the advantages of conventional T cells, which express alpha and beta TCR chains, with TCRs derived from gamma delta T cells that recognize novel targets in cancer cells, according to preclinical models evaluating the lead TEG candidates. Unlike alpha beta T cells, gamma delta TCRs do not require expression of cell surface proteins (major histocompatibility complex (MHC) molecules) for target recognition, and their ability to recognize novel targets under stress or metabolic conditions offer an attractive approach to develop potentially effective cell therapies in solid tumors.

Gadeta was founded in 2015 by Professor Jürgen Kuball, Mark de Boer, Utrecht Holdings and Medicxi, its founding investor.

“We continue to invest in research approaches that support the development of innovative cell therapies for people living with cancer,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy.“We are excited to work with Gadeta on its gamma delta TCR technology. This research collaboration adds an additional new platform to our current capabilities in research and cell manufacturing, and deepens our commitment to develop novel approaches to treat solid tumors.”

“Our mission is to develop novel gamma delta TCR cell therapies that have the potential to benefit patients with cancer,” said Shelley Margetson, Gadeta’s Chief Executive Officer. “We are excited to gain the support of a leader in the cell therapy field, which has seen the potential of our platform and products to redefine cancer therapy.”

 
About Gadeta
Gadeta has developed a technology platform based on combinatorial T cell receptor exchange (CTE) to create optimized gamma delta T cell receptors (TCRs) with an enhanced anti-cancer reactivity. The platform is based on research from Prof. Jürgen Kuball from University Medical Center Utrecht (UMC Utrecht) and Chief Scientific Officer at Gadeta. Gadeta’s investigational cell-based anti-cancer products called T Cells Engineered To Express A Defined Gamma Delta TCR (TEGs) have therapeutic potential for combating and eradicating both hematological and solid tumors. This approach utilizes high-affinity gamma delta TCRs expressed on alpha beta T cells with enhanced proliferation capacity.

About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.  The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead and Kite Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead and Kite may not realize the potential benefits of this collaboration with Gadeta or other investments in cell therapies.  All statements other than statements of historical fact are statements that could be deemed forward-looking statements.  These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the U.S. Securities and Exchange Commission.  All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

Contacts

Gilead/Kite
Sung Lee, Investors
+1 (650) 524-7792

Nathan Kaiser, Media
+1 (650) 522-1853

Gadeta
Shelley Margetson, CEO
+31 6 31 900 812

Hans Herklots (Media)
+41 79 598 7149

• Company to address unmet medical needs in the field of rare metabolic disorders
• Exclusive IP licensed from Leiden University and Amsterdam UMC
• Senior industry R&D leader Olivier Morand appointed as Chief Executive Officer and member of the Board of Directors
• BioGeneration Ventures founding investor

Leiden, The Netherlands, July 23, 2018 / B3C newswire / -- Azafaros, a biotech company established in Leiden in the Netherlands, focusing on the development of new therapies in the field of rare metabolic disorders, today announced the closing of a seed financing round. BioGeneration Ventures (BGV) is the founding investor.

Rare metabolic disorders such as lysosomal storage disorders (LSDs) represent a broad class of severe and sometimes life-threatening inherited diseases, presenting significant unmet medical needs, with only few approved therapies. With its proprietary small molecule compounds, Azafaros will concentrate on new treatments for patients suffering from LSDs and LSD-related diseases. These compounds interfere with the metabolism of glycolipids that is disturbed in these patients and are intended to counteract the underlying pathological effects.

Azafaros holds an exclusive license from Leiden University and Amsterdam UMC (location AMC) to a library of novel compounds and patents that were discovered by Professor Hans Aerts and his co-workers at Amsterdam UMC and Leiden University. Through a broad research collaboration Azafaros will benefit from the vast experience of the group led by Professor Hans Aerts to progress the technology.

Olivier Morand, Ph.D. and IMD alumnus, is joining Azafaros as Chief Executive Officer (CEO) and member of the Board of Directors. Olivier Morand, a senior leader in pharma strategic development for early- and late-phase products, brings many years of hand-on experience and know-how in rare metabolic disorders and orphan drugs. He has a very strong industry track record most recently at Idorsia Pharmaceuticals, and before that at Actelion Pharmaceuticals and Hoffmann-La Roche. In his early career, he held various roles in academic institutions such as INSERM Paris, the University of Wisconsin Madison, the Hadassah Medical School Jerusalem and the Mount Sinai Medical School New York. With this, Olivier Morand brings a broad scientific, clinical and regulatory experience as well as business insights to the Azafaros team.

Olivier Morand, CEO, says:“I feel very privileged to lead Azafaros. I anticipate that with our focused efforts the company will be able to develop high performing drugs out of the Leiden University and Amsterdam UMC compound library, supported by a solid patent position, and based on strong scientific rationale and sound clinical approaches.”

Edward van Wezel, managing partner at BGV and member of the Board of Directors, comments:“We are very excited to be able to support the development of new treatment modalities for LSDs with a founding team that has strong scientific and business experience in a field with clear unmet medical needs. We strongly believe that these new compounds have the potential to offer better clinical outcome for patients in the future.”

About Azafaros
Azafaros is a spin-off from Leiden University and Amsterdam UMC (location AMC). The company aims at developing therapeutic agents for the treatment of rare metabolic disorders such as lysosomal storage disorders through oral administration of aza-sugar compounds. These novel, very promising agents were discovered by Professor Hans Aerts at Leiden University and Amsterdam UMC and are exclusively licensed to Azafaros.

About BioGeneration Ventures
BioGeneration Ventures (BGV) is a specialized life sciences venture capital firm, with a focus on early stage European biotech, med-tech, and diagnostics companies. BGV has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class teams. BGV manages funds investing in areas where the science, the unmet medical need, and the potential to rapidly demonstrate a significant proof of concept all come together.

Successful investments include divestment of Dezima Pharma to Amgen for up to USD 1.55 billion in total deal value, and in Acerta Pharma for up to USD 7 billions. BGV was founding investor in both companies. The Acerta Pharma sale was the largest exit to date of a privately held European biotech company. Over the last decade BGV has made over 20 investments.

BGV is based in Naarden, The Netherlands, and closely collaborates with Forbion Capital Partners.

Contact

Azafaros B.V.
info@azafaros.com
+31 (0) 35 699 30 00
http://www.azafaros.com

Visiting address: J.H. Oortweg 21,
2333 CH Leiden, the Netherlands

Mailing address: Gooimeer 2-35,
1411 DC Naarden, The Netherlands

Posted by Sabine Duntze, B3C Group GmbH