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

SAN DIEGO, May 04, 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 European Medicines Agency (EMA) has granted TRC105 orphan drug designation for the treatment of patients with soft tissue sarcoma.

“Orphan drug designation by the EMA for TRC105 for the treatment of soft tissue sarcoma represents an important regulatory milestone and indicates concurrence that TRC105 may offer significant benefit versus approved drugs for this rare disease,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We look forward to presenting complete results from our Phase 2 sarcoma trial and initiating a pivotal Phase 3 trial in patients with angiosarcoma later this year.”

Orphan Drug Designation by the EMA Committee for Orphan Medicinal Products (COMP) provides regulatory and financial incentives under Regulation (EC) No. 141/2000 for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and for which no satisfactory treatment is available or for which the therapy offers significant benefit over available therapy. In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized marketing authorization procedure.

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 Soft Tissue Sarcoma

Sarcomas are rare tumors that originate from mesenchymal tissues (e.g., bone, cartilage, fat and muscle) that are capable of differentiation into different subtypes occurring in almost any anatomic site of the body. In Europe, the incidence of soft tissue sarcomas is approximately 4-5 per 100,000 per year. Sarcomas account for nearly 4-8% of all pediatric malignant tumors and less than 1% of all adult malignant tumors. According to the World Health Organization (WHO) classification of 2002, over 70 different types of sarcoma have been described. Localized tumors are curable but patients with metastatic disease have a median survival of approximately 12 months. 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: 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

This press release contains forward-looking statements, including statements regarding the potential benefits of Orphan Drug Designation by the EMA, an expected pivotal Phase 3 trial of TRC105 in patients with angiosarcoma, future presentations of clinical data 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, whether TRC105 will be shown to be safe and effective in on-going or future studies, the fact that results from subsequent clinical trials may not be consistent with those observed in earlier clinical trials or preclinical studies, and risks that TRACON may not be able to maintain Orphan Drug Designation or to realize all of the potential benefits of the designation. 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.