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TRACON Pharmaceuticals Announces Initiation of Dosing in a Phase 1/2 Neoadjuvant Study of TRC105 in Patients with Breast Cancer

SAN DIEGO, May 09, 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 that dosing has been initiated in a Phase 1/2 clinical trial evaluating TRC105 in combination with Afinitor® (everolimus), a mammalian target of rapamycin (mTOR) inhibitor, and Femara® (letrozole), an aromatase inhibitor, to treat patients with breast cancer prior to surgery.

"Our collaborators at the University of Alabama-Birmingham have demonstrated in previous studies that the addition of anti-angiogenic therapy to hormonal therapy in the neoadjuvant setting resulted in the down-staging of a significant proportion of breast cancer patients and could produce pathologic complete responses,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “The achievement of a pathologic complete response with neoadjuvant therapy in early-stage breast cancer is known to have a favorable impact on patient outcomes. As such, we look forward to assessing the ability of TRC105 to potentiate neoadjuvant treatment.”

The Phase 1/2 study is an open-label, non-randomized clinical trial of TRC105 in combination with Afinitor and Femara in post-menopausal women with newly diagnosed local or locally advanced, potentially resectable, hormone-receptor positive and Her2-negative non-metastatic breast cancer. Approximately 35 patients are expected to enroll in the trial at the University of Alabama-Birmingham and top-line data are expected in 2017. Additional information on the trial can be found at https://clinicaltrials.gov/, trial identifier NCT02520063.

About 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 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.

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.