Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy.
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Akeso, Ascentage, Astrazeneca, Chimeric, CSPC, Daiichi Sankyo, Elevation Oncology, Iaso, Immutep, Immvira, Innovent, Nkgen, Transcenta.
Despite the title of the Sunday, June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development.
In a deal potentially worth $392 million, C4 Therapeutics Inc. signed with Betta Pharmaceuticals Co. Ltd. to develop and market an orally bioavailable BiDAC degrader for non-small-cell lung cancer (NSCLC).
Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer.
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
Coherent Biopharma Co. Ltd. raised $100 million in series B and B+ financing rounds to step up its efforts to develop its bi-targeting ligand-drug conjugate (Bi-XDC) drugs and get them to market. Suzhou, China-based Coherent plans to use its newly expanded war chest to support the clinical trials of three candidates, CBP-1008, CBP-1018 and CBP-1019, as well as an IND application for CBP-8008 in China and the U.S., the company told BioWorld.
In a deal worth as much as $600 million, Lanova Medicines Ltd. licensed exclusive global rights to Astrazeneca plc for LM-305, an antibody-drug conjugate (ADC) targeting GPRC5D, for multiple myeloma (MM). Lanova will receive up-front and near-term payments of up to $55 million and development and commercial milestone payments of up to $545 million, as well as tiered royalties on net sales worldwide.