Acelyrin Inc., of Los Angeles, has launched with a series A funding from Westlake Village Biopartners to identify, acquire, develop and commercialize drug candidates in immunology. Company founders are Horizon Therapeutics plc alums: Shao-Lee Lin, who was chief scientific officer and head of R&D at Horizon, and Robert Carey, formerly Horizon’s executive vice president and chief business officer.
Allysta Pharmaceuticals Inc., of Bellevue, Wash., posted positive preclinical data in a study of its adiponectin analogue peptide, ALY-688, in a mouse model of nonalcoholic steatohepatitis conducted in collaboration with the University of Hong Kong. Results showed ALY-688 and adiponectin, a hormone produced by adipose tissue and helps regulate a range of cellular process in many organs, reduced inflammation and fibrosis while improving metabolic parameters. Allysta said it plans to initiate a phase I study of ALY-688 in the second quarter of 2021.
Anabios Corp., of San Diego, said the U.S. NIH awarded the company a phase I Small Business Innovation Research grant to further advance its human dorsal root ganglia platform for preclinical drug discovery. The grant is designed to allow Anabios to develop a battery of assays for a translational drug screening platform that will generate human-relevant data to assess the potential of a drug candidate's activity in specific pain states. Anabios focuses on pain, itch and cardiac disease.
Aprinoia Therapeutics Inc., of Taipei, said it executed a worldwide nonexclusive licensing agreement for Cambridge, Mass.-based Biogen Inc. to access Aprinoia's positron emission tomography (PET) imaging tracer, 18F-APN-1607, for neurodegenerative diseases. This is an extension of a collaboration between the two companies to discover novel PET imaging tracers for visualization and quantification of abnormal tau protein accumulation in the brain.
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, and Lonza Ltd., of Basel, Switzerland, said they expanded their exclusive manufacturing relationship to build a dedicated manufacturing capacity within Lonza’s existing small-molecule API facility in Visp, Switzerland, by 2023. The dedicated facility will provide cost and production efficiency to manufacture voclosporin while expanding existing capacity and providing supply security to meet future commercial demand. The agreement is conditional upon U.S. regulatory approval of voclosporin, a therapy in development for patients with lupus nephritis, an inflammation of the kidney. Voclosporin has a Jan. 22 PDUFA date.
Biontech SA, of Mainz, Germany, and Fosun Pharmaceutical Co. Ltd., of Shanghai, have agreed to supply mainland China with an initial 100 million doses of their BNT-162 mRNA-based vaccine candidate against COVID-19 in 2021, subject to regulatory approval. Initial supply will be delivered from Biontech’s production facilities in Germany. On Nov. 24, the companies initiated a phase II study of vaccine candidate BNT-162b2 in Jiangsu Province, China. The trial has 960 healthy participants between the ages of 18 to 85 to assess the safety and immunogenicity of the vaccine candidate and to support a BLA in China.
Genosity Inc., of Iselin, N.J., and Gemini Therapeutics Inc., of Cambridge, Mass., said they agreed to conduct molecular profiling to support clinical trial patient selection and stratification for Gemini’s GEM-103 program in age-related macular degeneration (AMD). Gemini will provide samples from prospective patients for their clinical trial for a customized next-generation sequencing panel, and Genosity will develop, CLIA validate and implement the molecular assay in its CLIA/GCP/GLP laboratory. Genosity will perform testing to support Gemini’s phase IIa trial in AMD to identify patients with defined molecular profiles suitable for enrollment in the study.
After meeting with the FDA to discuss a complete response letter tied to an NDA for filgotinib to treat rheumatoid arthritis (RA), Gilead Sciences Inc., of Foster City, Calif., and Galapagos NV, of Mechelen, Belgium, agreed not to pursue approval. Galapagos now assumes sole responsibility in Europe for filgotinib in RA, where 200-mg and 100-mg doses are approved for treating moderate to severe RA, and also in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe, and Gilead will receive royalties from filgotinib’s European sales.
Havn Life Sciences Inc., of Vancouver, British Columbia, is partnering with Complex Biotech Discovery Ventures Ltd., of Vancouver, British Columbia, to test the various extraction methods of psilocybin, which Havn plans to use to develop a library of compounds for researchers.
Heat Biologics Inc., of Durham, N.C., has completed development of ZVX-60, a gp96-based COVID-19 vaccine cell line that expresses gp96, OX40L and spike protein from SARS-CoV-2. The company is preparing to start manufacturing of the vaccine for a phase I trial.
Integra Lifesciences Holdings Corp., of Princeton, N.J., is acquiring Acell Inc., of Columbia, Md., for $300 million up front with the potential for another $100 million after achievement of certain revenue growth milestones. Through the deal, Integra gains access to Acell's Matristem UBM, a porcine urinary bladder matrix platform that includes products designed to restore tissue and minimize scarring. The deal with Acell, which is scheduled to close in the first quarter of 2021, is expected to have a neutral effect on Integra's adjusted earnings in the first year after closing and be accretive in year two.
Neubase Therapeutics Inc., of Pittsburgh, reported preclinical data for its compound A to treat myotonic dystrophy type 1 (DM1). In DM1 patient-derived fibroblasts, treatment with compound A rescued mis-splicing of MBNL1 and MBNL2 within two days, which continued through day nine, the latest timepoint analyzed. In a HSA-LR transgenic mouse model of DM1, a single intravenous injection of compound A induced broad correction of global exon inclusion levels of mis-spliced transcripts in skeletal muscle at day 13.
Oncoceutics Inc., of Philadelphia, licensed the rights to its oncology drug, ONC-201, in greater China to China Resources Sanjiu Medical & Pharmaceutical Co. Ltd. (CR Sanjiu), of Shenzhen, China. Oncoceutics will receive an undisclosed up-front payment and is eligible for milestone payments and royalties. CR Sanjiu will be responsible for running clinical trials required to obtain approval to market ONC-201 in China.
Relaxera Pharmazeutische Gesellschaft mbH h& Co. KG, of Bensheim, Germany, signed a contract with CBL Patras, of Patras, Greece, for the manufacturing of relaxin-2. Relaxera will sell the product, which is being studied as a treatment for heart failure with preserved ejection fraction.
Titan Pharmaceuticals Inc., of South San Francisco, regained compliance with Nasdaq's minimum bid price requirement. The scheduled hearing before the Nasdaq Hearings Panel has been canceled.
Takeda Pharmaceutical Co. Ltd., of Tokyo, reached an agreement with Prime Therapeutics LLC, of Eagan, Minn., for its hemophilia A treatment, Advate (antihemophilic factor). The payments for the drug take into account the total cost of care, including emergency department visits, for each patient.