South Korean pharmaceuticals Celltrion Inc. and Cyron Therapeutics Co. Ltd. are teaming up to discover and develop bispecific and trispecific antibodies, collectively called polyspecific antibodies, under the ₩1.158 trillion (US$882.38 million) joint research agreement inked on Dec. 6. Under the terms, privately held Daegu-based Cyron will discover and develop at least three polyspecific antibodies for blood and solid cancers pre-selected by Incheon-based Celltrion via Cryon’s CD-3 targeting T-cell engager platform that helps engage T cells to attack cancer cells.
The oral drug inavolisib, when added to two other therapies, significantly improved progression-free survival in the first-line phase III treatment of advanced hormone receptor-positive, HER2-negative breast cancer in which patients have a PIK3CA mutation.
Replimune Group Inc.’s lead candidate, RP-1 (vusolimogene oderparepvec), took a solid hit as it missed both primary endpoints in the Cerpass phase II study of skin cancer. Despite some better results from the study and good news from other studies along with a plan to drop some programs, the company’s stock still suffered.
Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
Simcere Pharmaceutical Group Ltd.’s subsidiary Simcere Zaiming Pharmaceutical Co. Ltd. has received FDA clearance of an IND application for SIM-0501, an oral small-molecule inhibitor of ubiquitin-specific peptidase 1 (USP1), for advanced solid tumors.
Voronoi and Voronoi Bio Inc. have patented heteroaryl derivative compounds acting as serine/threonine-protein kinase B-raf (BRAF) inhibitors and reported to be useful for the treatment of cancer.
Phosphatidylinositol 3-kinase α (PI3Kα) (H1047R mutant) inhibitors are described in a Relay Therapeutics Inc. patent as potentially useful for the treatment of cancer, particularly, breast and ovarian cancer.
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