The University of Oxford and Moderna Inc. have announced authorization by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome.
Researchers have identified a 14-protein blood signature that can predict lung cancer risk as much as five years before diagnosis, and the findings could help identify people who could benefit from preventive drugs. Published in Cell, the study was a collaboration between the Francis Crick Institute and University College London. It was co-led by Walter and Eliza Hall Institute laboratory head Clare Weeden, who conducted the research while at the Crick.
Tango Therapeutics Inc. will be sitting down with the U.S. FDA soon to discuss pivotal work ahead based on what Cantor analyst Eric Schmidt called “amazing” data from the phase I/II study of vopimetostat, a PRMT5 inhibitor, paired with Revolution Medicines Inc.’s RAS(ON) inhibitors in patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC) as well as non-small cell lung cancer.
Building on its partnerships with Gilead Sciences Inc., Sanofi SA and Pfizer Inc., Nurix Therapeutics Inc. brought on Roche Holding AG to help develop bexobrutideg, an oral degrader of Bruton’s tyrosine kinase (BTK). “I really can’t think of a better partner to maximize the opportunity for bexobrutideg to a wide range of patients,” Jason Kantor, Nurix’s chief business officer, told investors on a conference call, later pointing out that Roche has multiple drugs targeting B cells.
Empire Discovery Institute and the University of Rochester have discovered new interleukin-1 receptor-associated kinase 1 (IRAK-1) and/or IRAK-4 inhibitors potentially useful for the treatment of cancer, pain, fibrosis and inflammatory disorders.
Onkure Therapeutics Inc. has disclosed new benzopyridinones acting as phosphatidylinositol 3-kinase α (PI3Kα) mutant inhibitors potentially useful for the treatment of cancer, congenital lipomatous overgrowth, vascular malformations, epidermal naevi and skeletal abnormalities, scoliosis and PIK3CA-related overgrowth spectrum (PROS).
Hansoh Pharmaceutical Group Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for HS-10541 tablets.
Amphista Therapeutics Ltd. has obtained IND clearance from the FDA for AMX-883, an orally bioavailable degrader of BRD9, for the treatment of acute myeloid leukemia (AML). A phase I trial in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome is expected to begin in the second half of this year.
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