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TRACON Pharmaceuticals Initiates Dosing in Phase 1b/2 Study of TRC105 in Patients with Hepatocellular Carcinoma

SAN DIEGO, May 18, 2016 (GLOBE NEWSWIRE) -- 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 the initiation of dosing in a Phase 1b/2 clinical trial evaluating TRC105 in combination with Nexavar® (sorafenib), a vascular endothelial growth factor (VEGF) inhibitor, to treat patients with hepatocellular carcinoma (HCC).

"Hepatocellular carcinoma, the second leading cause of cancer deaths worldwide, is a vascular tumor with limited treatment options," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The combination of TRC105 and Nexavar demonstrated a 40% response rate at recommended TRC105 Phase 2 doses in a National Cancer Institute-sponsored trial. In order to further explore the safety and efficacy of the combination, TRACON has initiated a multi-center clinical trial in this widespread indication.”

The National Cancer Institute reported data from its Phase 1/2 trial examining the combination of TRC105 and Nexavar in HCC patients at the ASCO Annual Meeting in 2015. Four of 10 patients with measurable disease treated at recommended Phase 2 doses of TRC105 (10 mg/kg or 15 mg/kg dosed every two weeks) achieved partial responses by RECIST, a standardized radiographic response criteria. For comparison, the partial response rate of single agent Nexavar was 2% and 3% by RECIST in separate Phase 3 trials. The combination of TRC105 and Nexavar was well-tolerated in the NCI trial.

This Phase 1b/2 study is an open-label, nonrandomized clinical trial of TRC105 in combination with Nexavar in patients with HCC who have not received prior systemic therapy. TRC105 will be dosed every other week in combination with standard dose Nexavar (800 mg per day). Approximately 39 patients are expected to enroll at multiple centers in the United States and top-line data is anticipated in 2017. Additional information on the trial can be found at https://clinicaltrials.gov/, trial identifier NCT02560779.

About TRC105 and other Endoglin Antibodies

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 multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at http://www.traconpharma.com/clinical_trials.php.

About TRACON

TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.

Forward-Looking Statements

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's plans to further develop TRC105, expectations regarding the design, size and timing of TRACON’s Phase 1b/2 clinical trial of TRC105, and expected development milestones and availability of additional clinical data. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON will be able to complete clinical trials on expected timelines, if at all; the fact that clinical trials may not be successful or otherwise consistent with results from prior studies; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact: Casey Logan Chief Business Officer (858) 550‐0780 ext. 236 clogan@traconpharma.com Investor Contact: Andrew McDonald LifeSci Advisors LLC 646-597-6987 Andrew@lifesciadvisors.com

Source:TRACON Pharmaceuticals, Inc.