Companies from across the globe provide updates on their businesses and pipelines.
Abivax – France-based Abivax received approval from the U.S. Food and Drug Administration to begin clinical testing for its lead drug candidate ABX464, a potential treatment for moderate-to-severe ulcerative colitis. The Investigational New Drug Application will allow the company to initiate clinical trials in the U.S. and the first patients expected to be enrolled in the ongoing Phase 2b clinical trial ABX464-103 in the second quarter of this year. A Phase IIa trial in Europe showed that 75% of the patients with moderate-to-severe active UC, who had failed on immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids, were in clinical remission, meaning they were essentially symptom-free. In all clinical trials, ABX464 was safe and well-tolerated. There were no serious adverse drug reactions reported. Adverse events were typically of mild to moderate intensity.
Chi-Med -- Hutchison China MediTech Limited, better known as England’s Chi-Med, announced that the independent Data Monitoring Committee (IDMC) of the Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic (“SANET-p”) has completed a pre-planned interim analysis. The IDMC recommended that the study stops early as the pre-defined primary endpoint of progression-free survival had already been met. Chi-Med now plans to arrange a pre-New Drug Application meeting with the China National Medical Products Administration to discuss the preparation of the NDA for surufatinib for this indication. Chi-Med intends to submit the results of the SANET-p study for presentation at an upcoming scientific conference. In November, the FDA granted Orphan Drug designation to surufatinib for the treatment of pancreatic neuroendocrine tumors. The China NDA for surufatinib for the treatment of advanced non-pancreatic neuroendocrine tumors was accepted for review by the NMPA, and was subsequently granted Priority Review status in December. Currently, Chi-Med is building an oncology-focused sales and marketing team to launch surufatinib if approved in China.
Osteolabs –Germany’s osteolabs GmbH announced the successful closing of its first commercial agreements for Germany and Turkey. For Germany, the company has signed up with Eurofins LifeCodexx GmbH as exclusive partner in the field of gynecology for the commercialization of its novel diagnostic test for early detection of osteoporosis. In Turkey, a similar agreement was signed with BioGen Medical, a leading distributor for laboratory developed tests. The osteolabs test will be used in a comprehensive contract research collaboration with the Health Department of a European Army over the course of three years. During that time, over 1,000 tests will be performed to determine the correlation of calcium depletion with intense physical activities and bone fractures in female military staff. The application of the osteoporosis test should allow to further validate the potential of the test for early detection of calcium depletion from the skeleton which could be further used for therapeutic monitoring of osteoporosis medications, the company said.
Jazz Pharmaceuticals – The European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA. The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.
BioCat – Spain’s Biocat opened the call for applications to the second edition of CRAASH Barcelona, a 12-week acceleration program that helps research teams from European countries successfully launch innovation to market in the healthtech arena. The deadline for applications is March 16. Participants will be guided by expert mentors from CIMIT, a healthcare accelerator based in Boston. This is the third edition of CRAASH Barcelona, a program started in 2018 that has emerged 18 projects since then. One of them is ABLE Human Motion, a lightweight exoskeleton for people with lower-limb paralysis that restores their ability to walk.
HepaRegniX – HepaRegniX GmbH, based in Germany, closed an €11 million Series B financing round supported by companies such as Boehringer Ingelheim and Novo Nordisk. The proceeds will be used to advance the first MKK4 inhibitor for the treatment of acute and chronic liver diseases to the clinics later in 2020. MKK4 (Mitogen-Activated Protein (MAP) Kinase 4) is a key regulator of liver regeneration and suppression of MKK4 unlocks the regenerative capacity of hepatocytes even in severely diseased livers. Over the last 2.5 years, HepaRegeniX focused on the discovery of new and proprietary MKK4 inhibitors which led to the identification of several preclinical drug candidates.
Cambridge Healthtech Institute – The Bioprocessing Summit Europe will return, CHI announced. The summit will include approximately 30 new sessions on Analytical and Formulation topics. The conference will be held March 24-26 in Barcelona. The sessions at the summit will provide solutions to the challenges of producing complex biologics while maximizing quality, risk management and cost-efficiency. Experts from such organizations as Novartis, Pfizer, National Institute for Bioprocessing Research and Training, Roche, Merck, Sanofi-Aventis and Bristol-Myers Squibb will share scientific data, insights and case studies on technologies and processes.
Horizon Discovery Group -- The U.K.’s Horizon Discover Group plc licensed its gene-edited Glutamine Synthetase (GS) knockout Chinese Hamster Ovary (CHO) K1 cell line to NGM Biopharmaceuticals, Inc. NGM is focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. Horizon’s GS knockout CHO K1 cell line facilitates the development of stable cell lines for the expression of antibodies and other recombinant proteins.
TISSIUM – Privately-owned Tissium, which is based in Paris, was named a French Tech 120 company. French Tech 120 is a growth-stage program by La French Tech, built to provide government-backed support for the 120 fastest growing companies in France. The objective of this French government-backed program is intended to stimulate growth and create opportunities in France. Tissium is being recognized by La French Tech, for having a high potential of becoming a global technology leader. They are being recognized as one of the most promising young companies in the country and will receive a year of unprecedented government support, with all state services being mobilized in a way specifically designed to speed growth and benefit the company.
Elypta – Sweden-based Elypta, a molecular diagnostics company, raised €6.1 million in a late seed funding round. The company will use the funds to complete the development of its laboratory kits and software for measurement and analyses of a panel of metabolites deemed most promising for cancer diagnostics. Elypta’s technology is being developed to ultimately be validated across multiple cancers and address a global market. The initial application will be a urine test for early detection of recurring kidney cancer, a condition where there are no suitable tests currently available. The application is currently being explored through the pivotal AURORAX-87A study.
Cartana -- The European Union’s Horizon 2020 funding program confirmed support for six pilot European Human Cell Atlas projects designed to contribute to the international Human Cell Atlas initiative (HCA) with studies of the brain, uterus, lung, pancreas and human gonad development. In parallel, Swedish biotechnology company Cartana today announced that it is to become a full partner three out of the six funded HCA projects, whereby its In Situ Sequencing technology will be applied to spatially map cell types in the different tissue samples. ISS enables single-cell gene expression analysis directly inside the tissue samples, while preserving spatial information, thus enabling the creation for the first time of spatial human cell atlases. The Horizon 2020 HCA projects aim to deliver an important contribution to the international Human Cell Atlas initiative (HCA) which will create molecularly defined reference maps of all the cells comprising the human body.
