On November 29, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that the first patient has been dosed in its Phase 1b clinical trial of TRC105 in combination with Opdivo (nivolumab) in patients with non-small cell lung cancer (Press release, Tracon Pharmaceuticals, NOV 29, 2017, View Source;p=RssLanding&cat=news&id=2319234 [SID1234522312]).
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"Endoglin is expressed on activated myeloid derived suppressor cells, a cell type implicated in tumor resistance to immunotherapy. To date, we have observed promising signs of activity with our endoglin antibodies in combination with PD-1 inhibitors in a number of preclinical syngeneic mouse tumor models," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are excited to advance a combination of TRC105 with an immune oncology agent into the clinic to further assess our antibody’s immunomodulatory activity."
About the Phase 1b Clinical Trial of TRC105 and Opdivo in Lung Cancer
The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when given with Opdivo, determine its recommended Phase 2 dose with Opdivo and evaluate the response rate. The trial incorporates tumor biopsy testing to correlate tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy of lung cancer patients.
Further details of the study are available on www.clinicaltrials.gov, identifier NCT03181308.
About Carotuximab (TRC105)
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.