Researchers from Scorpion Therapeutics Inc. presented preclinical data for the novel EGFR exon 20 mutant inhibitor STX-721, being developed for the treatment of non-small-cell lung cancer (NSCLC).
Mirati Therapeutics Inc. has described GTPase KRAS (G12C mutant) inhibitors reported to be useful for the treatment of cancer, in particular non-small-cell lung cancer (NSCLC).
Navrogen Inc. has entered into a cooperative research and development agreement (CRADA) with researchers at the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Under this CRADA, Navrogen will sponsor the clinical investigation of the experimental antibody-drug conjugate (ADC) NAV-001, under supervision of the NCI.
Lyell Immunopharma Inc. has received FDA clearance for its IND application to initiate a phase I trial for LYL-845, an investigational tumor-infiltrating lymphocyte (TIL) therapy enhanced with Lyell's Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.
Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed from a U.S. FDA advisory committee Sept. 22 for its non-small-cell lung cancer candidate, poziotinib, which it has proposed marketing as Pozenveo.
The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test.
Lift Biosciences Ltd. has shown that its first-in-class cell therapy destroyed on average over 90% of the tumoroid in a PDX (patient-derived xenograft) organoid across five solid tumor types, including bladder cancer, rectal cancer, colorectal cancer, gastric cancer and squamous cell non-small-cell lung cancer (NSCLC).
It’s another setback for Jounce Therapeutics Inc. Top-line data from the phase II Select study of vopratelimab, the company’s lead candidate, combined with pimivalimab vs. pimivalimab alone in 69 patients missed its primary endpoint of mean tumor change when averaged over nine and 18 weeks. The clinical trial participants were immunotherapy naïve, immunotherapy TISvopra biomarker-selected, second-line non-small-cell lung cancer (NSCLC) patients.
Having initiated its first two clinical trials in non-small-cell lung cancer since January, Nuvalent Inc. said it expects to unveil preliminary dose-escalation data before year-end. Ahead of the data, Nuvalent's phase I/II Arros-1 trial evaluating NVL-520, a kinase inhibitor, in patients with advanced ROS1-positive NSCLC and other solid tumors, continues to enroll participants.
