NEW YORK – Genprex this week advanced its Phase I/II Acclaim-1 trial into a second cohort of patients at a higher dose after an evaluation of cohort one by a safety review committee. The trial is evaluating Genprex's Reqorsa (quaratusugene ozeplasmid) plus AstraZeneca's Tagrisso (osimertinib) in late-stage non-small cell lung cancer patients with activating EGFR mutations who have progressed on Tagrisso. The trial will include three dose cohorts to identify the recommended Phase II dose. The company's Chief Medical Officer Mark Berger said in a statement that enrollment in the trial was on track to complete the Phase I portion of the study by year-end.
Strata Oncology this week added eight sites affiliated with the Sarah Cannon Research Institute to its Strata PATH clinical trial. Patients can now be enrolled through Florida Cancer Specialists; Genesis Cancer and Blood Institute in Hot Springs, Arkansas; Hematology Oncology Clinic in Baton Rouge, Louisiana; Tennessee Oncology in Chattanooga, Tennessee; and Zangmeister Cancer Center in Columbus, Ohio. The Strata PATH trial is evaluating several US Food and Drug Administration-approved drugs in biomarker-guided patient populations. In May, the trial began enrolling patients with advanced solid tumors or early-stage cancer patients who have evidence of micro-metastatic disease.
Bristol Myers Squibb this week completed its acquisition of Turning Point Therapeutics. The deal, announced in June, was valued at $4.1 billion. BMS now has rights to Turning Point's lead candidate repotrectinib, which is being studied in a Phase I/II trial in ROS1-positive advanced non-small cell lung cancer and in NTRK-positive advanced solid tumors. Turning Point is also developing TPX-0046, a RET/SRC inhibitor; TPX-0022, a MET/CSF1R/SRC inhibitor; and TPX-0131, an ALK inhibitor. BMS expects repotrectinib to be approved in ROS1-positive NSCLC in the US in the second half of 2023.
AUM Biosciences this week said that the US Food and Drug Administration granted orphan drug designation to its tyrosine kinase inhibitor AUM601. AUM is planning a Phase II trial to study safety and efficacy in patients with tumors bearing NTRK fusions and mutations.
Menarini Group this week said that the European Medicines Agency has accepted its marketing authorization application for elacestrant as a treatment for estrogen receptor-positive, HER2-negative advanced breast cancer patients. The company submitted data from the Phase III EMERALD trial, which showed patients on elacestrant had better outcomes than those on standard-of-care treatments. The oral selective estrogen receptor degrader demonstrated efficacy both in the overall population and in patients with ESR1-mutated tumors. Menarini earlier this month said the US Food and Drug Administration has also accepted a new drug application for elacestrant in this setting.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.