A collection of recently published news items.
In a deal worth up to $5.2 billion, Sanofi announced it will collaborate with Ex-scientia to develop up to 15 novel small-molecule candidates to treat cancer and immune-mediated diseases, taking advantage of Exscientia's artificial intelligence (AI) expertise. By applying AI and machine learning to tissue samples, researchers will shorten drug discovery and development times—and design higher-quality and more-effective targeted therapies, the companies said.
Daiichi Sankyo announced that it will shutter Plexxikon at the end of March. The Japanese company said that it wanted to maximize its investments in three antibody–drug conjugates for cancer, including, in partnership with AstraZeneca, trastuzumab deruxtecan (Enhertu). Plexxikon's portfolio includes the BRAF inhibitor vemurafenib (Zelboraf).
Gilead announced that it will withdraw two indications for idelalisib (Zydelig): relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukemia. The drug's 2014 accelerated approval to treat these conditions was contingent upon additional evidence of clinical benefit, but enrollment in a confirmatory study proved challenging, prompting the withdrawal of these indications in the United States.
The FDA gave Allogene the OK to resume testing its allogeneic chimeric antigen receptor (CAR) T-cell therapies. The agency had placed a clinical hold on five of the company's trials of “off-the-shelf” CAR therapies in October after a chromosomal abnormality was detected in a patient who received ALLO-501a. However, an investigation determined that the anomaly wasn't related to the company's gene editing and manufac-turing processes and had no clinical significance.
The European Commission approved Amgen's sotorasib (Lumakras) for patients with KRASG12C-mutated advanced non–small cell lung cancer (NSCLC). The decision was based on results from the phase II CodeBreaK 100 clinical trial in which 126 patients with KRASG12C-mutant NSCLC demonstrated an objective response rate of 37.1% and a median duration of response of 11.1 months.