Zelluna ASA has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1 (ZIMA-101), the company’s lead candidate. ZI-MA4-1 is a novel MAGE-A4-targeting T-cell receptor-natural killer (TCR-NK) therapy.
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).
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).
Immutep Ltd.’s stock surged 31% on Tuesday morning following the news that it out-licensed rights to Dr. Reddy’s Laboratories Ltd. to develop and commercialize eftilagimod (IMP-321, efti) in selected territories in a deal worth AU$528.4 million (US$349.5 million).
Crescent Biopharma Inc. has announced a new partnership with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. and reported progress across its pipeline, with three distinct programs set to enter the clinic next year.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
METTL3, the enzyme that adds the m6A RNA modification, is a key regulator of RNA processing and protein synthesis. In cancer, METTL3 is often overexpressed, driving tumor growth, invasion and therapy resistance across multiple malignancies, including lung, pancreatic, ovarian, colorectal cancers and acute myeloid leukemia.
