Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
Atara Biotherapeutics Inc. is keeping the faith and figuring out next steps with its next-generation, mesothelin-directed CAR T-cell therapies after Bayer AG ended their exclusive worldwide licensing agreement, signed in late 2020. The setup included funding and development of ATA-3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA-2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.
Inceptor Bio LLC, a company developing cell therapies for difficult-to-treat cancers, has closed a $37 million series A financing led by Kineticos Ventures, the second fund founded by Inceptor CEO Shailesh Maingi. Altogether, about 40 investors have supported the company's efforts, he told BioWorld. Proceeds from the round, which follows a $26 million seed financing in 2021, will support moving Inceptor's lead CAR T program into phase I testing, a move targeted for the second half of 2023, and continued development of rare CAR-macrophage and CAR-natural killer cell programs.
Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea.
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
Off-the-shelf cancer vaccine specialist Nouscom AG has taken the wraps off a multiproject agreement with Janssen Research and Development LLC, after the lead candidate received FDA approval to enter clinical trials.
Astrazeneca plc has signed up for more of the heavy-duty structure-based drug discovery services Proteros Biostructures GmbH specializes in, inking an extension to their existing collaboration agreement.
Kriya Therapeutics Inc. has raised a $270 million series C financing to further develop its pipeline of gene therapies for treating cancer, ophthalmological problems, and rare and chronic diseases. The Redwood City, Calif.-based company has greatly expanded its employee roster, from about seven people to around 160 people, since its $80 million series A in May 2020 and scaled its learning-enabled tech and cloud computing abilities. It also further solidified its technology, manufacturing, R&D, and therapeutics units, something it plans to continue with the series C money.
A move by Chimerix Inc. to strengthen its balance sheet by $225 million through the sale of smallpox drug Tembexa (brincidofovir) to biodefense specialist Emergent Biosolutions Inc. and extend its cash runway into 2026, should have proved a big win. Instead, shares (NASDAQ:CMRX) plunged nearly 61% May 16 on worry that Chimerix might be handing off a likely profitable program to fund a riskier oncology pipeline, a concern heightened by recent U.S. FDA feedback indicating lead oncology program ONC-201 might not be eligible for accelerated approval as previously expected.
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