Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology. Sanofi will be responsible for later-stage research and all clinical, product development and marketing activities.
After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Reports of two patient deaths prompted Celyad Oncology SA to voluntarily pause a phase Ib trial testing its allogeneic CAR T-cell therapy, CYAD-101, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with refractory metastatic colorectal cancer (mCRC), the latest safety hitch among efforts to advance the promise of CAR T beyond the first approvals in hematological malignancies.
LONDON – Antibody-drug conjugate specialist Heidelberg Pharma AG has secured a route into Asia and a fresh injection of much-needed capital, in a licensing and equity deal with Huadong Medicine Co. Ltd. worth up to €930 million (US$1.1 billion).
Odeon Therapeutics Inc. has acquired rights to two cancer candidates from Obi Pharma Inc. in a deal worth up to $200 million. The transaction gives Shanghai-based Odeon rights to develop, register, and commercialize the antibody-drug conjugate OBI-999 and a therapeutic cancer vaccine OBI-833 in mainland China, Hong Kong, and Macau.
Jubilant Therapeutics Inc. started 2022 with an IND clearance for JBI-802, its oral, selective dual inhibitor of lysine-specific demethylase 1 (LSD1) and HDAC6, setting up a year that could be important for LSD1 in the hands of others as well.
Biontech SE and Medigene AG have signed a three-year research collaboration to develop T-cell receptor (TCR) based immunotherapies against cancer. Medigene will receive €26 million ($29.5 million) up front and could receive hundreds of millions of euros per drug in milestone payments from the deal, which will also covers research funding for the period of the collaboration.
After a landmark clinical trial of the first POLQ inhibitor in cancer last year, a recently formed U.K. biotech is gearing up to bring a potential rival to the clinic in the coming months. Varsity Pharmaceuticals Ltd., of Cambridge, is planning to begin a phase I trial of novobiocin, a drug previously used as an antibiotic, which has also been found to inhibit the polymerase theta inhibitor (POLQ) pathway.
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand.
Marker Therapeutics Inc.’s update from the safety lead-in stage of its phase II study of MT-401 in treating post-transplant acute myeloid leukemia saw response in one of the six participants. The results from the study of the multitumor-associated antigen-specific T-cell product also known as zelenoleucel saw firms such as Oppenheimer cut its target price for Marker to $5 from $8 and Piper Sandler to cut its target price from $5.50 to $4.
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