TRACON Pharmaceuticals Announces Positive Data from Ongoing Phase 1b/2 Trial of TRC105

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, today announced that positive clinical data from its ongoing Phase 1b/2 study of TRC105 and Nexavar (sorafenib) in patients with advanced hepatocellular carcinoma (HCC) were presented in a poster presentation at the ASCO 2019 Gastrointestinal Cancers Symposium in San Francisco on January 18, 2019.

As quoted in the press release:

Data from the ongoing open-label, non-randomized study were presented by Dr. Kanwal Raghav from the University of Texas MD Anderson Cancer Center. Key results included:

Confirmed partial response by RECIST 1.1 occurred in 3 of 15 (20%) evaluable patients and a reduction of 50% or greater in alpha fetoprotein (AFP) concentration occurred in 8 of 16 (50%) evaluable patients. Reduction in AFP, a tumor marker expressed in patients with HCC, in early treatment may help predict a favorable response to treatment.

Adverse events expected of each drug did not increase in frequency or severity when TRC105 and sorafenib were administered concurrently.

TRC105 trough concentrations were lower in HCC patients compared with prior TRC105 studies in other tumor types, and weekly dosing at the recommended Phase 2 dose of TRC105 of 10 mg/kg, rather than every other week dosing, was required to exceed target concentrations consistently. This may reflect increased target mediated clearance in HCC patients via fibrotic/cirrhotic liver disease.

Anti-drug antibody (ADA) was observed more frequently in patients with HCC (76%) compared with prior studies of TRC105 in other tumor types (e.g., in RCC, sarcoma, and lung cancer patients where ADA has been ~5%) and may have influenced pharmacokinetics in individual patients.

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