BioSpace Global Roundup, Nov. 28
Teva – Israel-based Teva Pharmaceutical Industries and Tel Aviv University expanded their scientific collaboration on cancer and brain studies. Teams from the company and university are collaborating on the efficacy of immunotherapy in unique models, by incorporating advanced analyses of the immune system. In addition, they explore ways to improve antibody production by utilizing advanced bioinformatics tools and promote projects aimed at finding new mechanisms to understand nervous system disorders. Over the past year, Teva has engaged in an extensive search to locate over 400 laboratories at Israeli academic institutions and has initiated strategic collaborations with leading research groups at Israeli universities. These joint ventures will create substantial added value for both academia and for Teva.
HALIX – Halix, located in the Netherlands, opened its new 72,000 square-foot facility at Leiden Bio Science Park. The new facility supports the basis for HALIX growth and expansion strategy. The site will enable HALIX to support its clients’ manufacturing of protein-based products. The new building houses GMP production areas for viral and protein products and client-specific technologies, as well as associated laboratory and administration areas. HALIX produces vaccines to prevent spreading those infectious and other viral diseases. HALIX is also focusing on therapeutic vaccines, specific oncolytic therapeutic vaccines such as to cure dedicated types of cancer.
Abivax – France-based Abivax announced that the French National Regulatory Authority approved the ABX464-103 Phase IIb study of its lead product candidate ABX464, an oral treatment of patients with moderate to severe active ulcerative colitis. Proof-of-concept studies showed that 75% of all evaluable patients were in clinical remission and free of symptoms after two months induction and 12 months maintenance. The company hopes to confirm the outcomes in a statistically relevant number of patients in the IIb trial.
Chi-Med -- Hutchison China MediTech Limited, better known as Chi-Med, received Orphan Drug designation from the U.S. Food and Drug Administration for surufatinib, a treatment of pancreatic neuroendocrine tumors. Surufatinib is under investigation in multiple solid tumors in China and the U.S., both as a monotherapy and in combination with immunotherapies. If approved by the FDA as an orphan treatment, surufatinib will be entitled to seven years of market exclusivity for the approved indication. Surufatinib is the second novel oncology drug discovered by Chi-Med to successfully complete a Phase III trial in China. A New Drug Application for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration earlier this month.
Vaccitech – London-based Vaccitech Ltd., a T-cell immunotherapy-focused company, reported successful recruitment and vaccination for its Universal influenza A vaccine MVA-NP+M1 (VTP-100), across two Phase II clinical studies, FLU009 and FLU010. The Phase II studies are part of a dual development pathway for VTP-100 that will address both pandemic and seasonal influenza vaccine markets. Data from FLU010 is expected in early 2020.
EOS Imaging -- 2D/3D orthopedic medical imaging company EOS Imaging, based in Paris, announced the launch of its new generation imaging system, EOSedge, in Europe, Canada and Australia. The new system will debut at the upcoming Radiological Society of North America (RSNA) 2019 Annual Meeting on Dec. 1. EOSedge combines technological innovations in X-ray detection, low-dose radiation and high image resolution, to deliver musculoskeletal imaging exams. The system incorporates new Flex Dose technology to modulate radiation dose along the patient’s body as well as high-resolution photon-counting detection to provide optimal image quality for musculoskeletal radiography, the company noted. EOSedge has been approved in Europe, Canada and Australia and is awaiting a pending 510(k) review from the U.S. Food and Drug Administration.
Merck – Pharma giant Merck’s vaunted checkpoint inhibitor Keytruda won approval in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. This approval marks Keytruda as the first anti-PD-1 therapy approved in China in combination with chemotherapy for the first-line treatment of squamous and nonsquamous NSCLC, as well as in the monotherapy setting for appropriate patients with NSCLC, the company said. The approval is also the third first-line approval in NSCLC in China for Ketruda in less than one year.
Inceptua Group – Germany-based Inceptua and Bendalis GmbH, a German manufacturer of generic oncology drugs, signed an exclusive clinical trial supply agreement for oncology generics. Through this agreement, Inceptua becomes the exclusive distributor of Bendalis’ products for their use in clinical trials worldwide, “offering clinical trial sponsors quick access to Brexit-safe oncology standard of care medicines produced within the European Union.” As a part of the agreement, Bendalis will maintain stock of specific products on a consignment basis, offering Inceptua’s clients "on-demand" access.