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, 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


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

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

Source:TRACON Pharmaceuticals, Inc.