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TRACON Announces FDA Orphan Drug Designation for TRC105 in Soft Tissue Sarcoma

SAN DIEGO, Jan. 25, 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, announced today that the U.S Food and Drug Administration (FDA) has granted TRC105 orphan drug designation for the treatment of patients with soft tissue sarcoma.

“Orphan drug designation for TRC105 underscores the high level of unmet medical need in patients with soft tissue sarcomas and validates our commitment to developing TRC105 in a variety of orphan drug indications,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We are highly encouraged by the clinical data reported to date from the Phase 1b/2 trial of TRC105 in sarcoma patients, especially in patients with angiosarcoma. We look forward to the availability of complete results from the Phase 2 portion of the sarcoma trial and initiating a pivotal Phase 3 trial in patients with angiosarcoma in 2016.”

The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the U.S. With orphan designation, TRACON qualifies for various incentives with respect to TRC105 for the treatment of soft tissue sarcoma, including tax credits for qualified clinical trials and seven years of market exclusivity upon regulatory approval.

About TRC105 and TRC205

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 both TRACON and the National Cancer Institute for the treatment of multiple solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is being developed in a Phase 1 trial in 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 Soft Tissue Sarcoma

Sarcomas are rare tumors that originate from mesenchymal tissues (e.g., bone, cartilage, fat and muscle). In the U.S., the incidence of soft tissue sarcomas is approximately 13,000 new cases per year, leading to approximately 5,000 deaths annually. Sarcomas account for nearly 21% of all pediatric solid cancers and less than 1% of all adult solid cancers. According to the WHO classification of 2002, over 70 different types of sarcoma have been described. The rarity and heterogeneity of the disease render sarcoma difficult to study and to treat. Endoglin, the target of TRC105 treatment, is overexpressed on many sarcoma subtypes, including angiosarcoma.

About TRACON

TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The company’s clinical-stage pipeline includes two product candidates: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers and 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

This press release contains forward-looking statements, including statements regarding an expected pivotal Phase 3 trial of TRC105 in patients with angiosarcoma and the potential for TRC105 as a treatment for sarcoma. Forward-looking statements speak only as of the date of this press release and TRACON does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding potential delays in initiating clinical trials and whether TRC105 will be shown to be safe and effective in on-going or future studies. For a further description of these and other risks facing TRACON, please see the risk factors described in TRACON’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and TRACON undertakes no obligation to update or revise these statements, except as may be required by law.



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.