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.The Up-and-Coming Company of the Year Award recognizes Michigan companies across all stages of growth that are producing groundbreaking solutions in their industry. Menarini earlier this month said the US Food and Drug Administration has also accepted a new drug application for elacestrant in this setting. The oral selective estrogen receptor degrader demonstrated efficacy both in the overall population and in patients with ESR1-mutated tumors. 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. 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.
#Strata oncology trial
AUM is planning a Phase II trial to study safety and efficacy in patients with tumors bearing NTRK fusions and mutations. BMS expects repotrectinib to be approved in ROS1-positive NSCLC in the US in the second half of 2023.ĪUM Biosciences this week said that the US Food and Drug Administration granted orphan drug designation to its tyrosine kinase inhibitor AUM601. 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 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. The deal, announced in June, was valued at $4.1 billion. In May, the trial began enrolling patients with advanced solid tumors or early-stage cancer patients who have evidence of micro-metastatic disease.īristol Myers Squibb this week completed its acquisition of Turning Point Therapeutics.
The Strata PATH trial is evaluating several US Food and Drug Administration-approved drugs in biomarker-guided patient populations. 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. Strata Oncology this week added eight sites affiliated with the Sarah Cannon Research Institute to its Strata PATH clinical trial. 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. The trial will include three dose cohorts to identify the recommended Phase II dose.
#Strata oncology plus
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. 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.
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