On December 26, 2018 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 and fibrotic diseases, reported positive top-line clinical results from a Phase 1 study of TRC105 and Opdivo (nivolumab) for the treatment of non-small cell lung cancer (Press release, Tracon Pharmaceuticals, DEC 26, 2018, View Source [SID1234532276]).

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In this Phase 1b trial, patients with refractory metastatic non-small cell lung cancer were enrolled regardless of baseline PD-L1 tumor expression. Patients were treated with 8 mg/kg or 10 mg/kg of TRC105 weekly for four doses and then 15 mg/kg every two weeks, in combination with the approved dose of Opdivo of 240 mg every two weeks. Best response was assessed by immune RECIST 1.1.

The combination of TRC105 and Opdivo was well-tolerated without the development of dose limiting toxicity in six patients who were treated as part of dose escalation. One of these six patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 10 months. Two of the other five patients, one of whom who progressed following prior Opdivo treatment, remain on trial with stable disease. Patients are currently enrolling into two parallel 12 patient expansion cohorts, one that includes patients who have relapsed following prior PD-1/PD-L1 checkpoint inhibition treatment and one that consists of patients who have not received prior PD-1/PD-L1 checkpoint inhibition treatment.

"We initiated this Phase 1 trial based on the potentiation of PD-1 checkpoint inhibition observed with TRC105 in pre-clinical models. We are pleased that TRC105 was well-tolerated with Opdivo, and with the early evidence of activity seen in the study," said Charles Theuer, M.D. Ph.D., President and CEO of TRACON. "We expect to present data from the expansion cohorts in mid-2019."

Further details of the dose escalation portion of the study will be presented at the International Association for the Study of Lung Cancer (IASLC) annual meeting in February 2019 in Santa Monica, CA, by Dr. Francisco Robert of the University of Alabama, Birmingham.

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 a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. 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.