Pilatus Biosciences Inc. has obtained IND clearance from the FDA for PLT-012, a first-in-class anti-CD36 monoclonal antibody, for the treatment of solid tumors. Pilatus plans to initiate a first-in-human phase I trial with this metabolic checkpoint antibody in the first quarter of next year.
Nectin-4 is a cell-surface protein that is highly expressed in a variety of solid tumors, including bladder, head and neck, and certain aggressive breast cancers. Its low-level expression in some normal tissues creates a challenge for therapies, which can unintentionally damage healthy cells and trigger severe side effects.
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease.
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
Apollo AP45 Ltd. has described eukaryotic translation initiation factor 2-α kinase 3 (PERK) inhibitors reported to be useful for the treatment of cancer.
Shanghai Aryl Pharmtech Co. Ltd. and Zhejiang Hisun Pharmaceutical Co. Ltd. have synthesized aza-tricyclic derivatives acting as Werner syndrome ATP-dependent helicase (WRN; RECQ3; RECQL2) inhibitors reported to be useful for the treatment of cancer.
Shenzhen Targetrx Inc. has disclosed proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase-binding moiety covalently linked to a Bcr-Abl (Bcr-Abl1) kinase and its mutant targeting moiety through a linker reported to be useful for the treatment of cancer and immunological disorders.
Pancreatic cancer is a leading cause of cancer-related deaths worldwide and presents a 5-year survival rate of under 12%. Most patients are diagnosed at an advanced stage, with over half of them presenting with metastatic disease at diagnosis.
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