Strategic Licensing Collaboration with Janssen Expanded TRACON’s Oncology Portfolio and Validated Company’s Unique Clinical Development Capabilities
Key Elements of Initial Phase 3 Trial of TRC105 Confirmed Through Discussions with U.S. FDA and
European Regulatory Agencies
SAN DIEGO, Nov. 08, 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 financial results for the third quarter ended September 30, 2016, and provided an update on recent corporate events.
Third Quarter 2016 and Recent Corporate Highlights
- Entered into a strategic licensing collaboration with Janssen Pharmaceutica N.V. (Janssen) for two novel oncology assets from Janssen’s early development portfolio. TRC253, intended for the treatment of men with prostate cancer, is a Phase 1/2 ready novel small molecule high affinity competitive inhibitor of wild type androgen receptor (AR) and multiple AR mutant receptors that may display drug resistance to Xtandi® (enzalutamide). TRC694, intended for the treatment of patients with hematologic malignancies, including myeloma, is a pre-clinical asset that is a potent, oral inhibitor of NF-kB inducing kinase (NIK).
- Concurrent with the strategic licensing collaboration, Johnson & Johnson Innovation – JJDC, Inc. (JJDC) completed a $5.0 million equity investment in TRACON through the purchase of 840,022 shares of common stock at $5.95 per share determined by the average of the daily volume weighted average closing prices of the common stock as reported on NASDAQ for the five days prior to the date of the purchase.
- Announced the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) and a Protocol Assistance Meeting with the European Medicines Agency (EMA). TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate the Phase 3 study by year-end, following an expected special protocol assessment (SPA) agreement with the FDA.