TRACON Pharmaceuticals Initiates Phase 1b Study of TRC105 in Patients with Lung Cancer

SAN DIEGO, March 14, 2016 -- 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 it has initiated dosing in a Phase 1b clinical trial evaluating TRC105 in combination with Avastin® (bevacizumab), a vascular endothelial growth factor (VEGF) inhibitor, and carboplatin and paclitaxel chemotherapy in patients with non-small cell lung cancer.          

"Angiogenesis is a major contributing factor to lung cancer and despite recent advances, lung cancer remains a disease with limited treatment options," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Previous clinical studies have demonstrated that TRC105 is well tolerated in combination with Avastin, and based on the positive safety profile and strong scientific rationale, we are moving forward with this TRACON-sponsored clinical trial to assess the safety and efficacy of the combination with standard chemotherapy agents recommended to treat this disease.”

TRACON is developing TRC105 using a tiered strategy and expects multiple milestones in 2016: initiation of pivotal studies in the ultra-orphan indications of angiosarcoma and gestational trophoblastic neoplasia (GTN); top-line Phase 2 data from mid-size market indications of soft tissue sarcoma, renal cell cancer, hepatocellular cancer and glioblastoma; and the commencement of additional Phase 1 clinical trials in large market indications.

The Phase 1b lung cancer study is an open-label, nonrandomized clinical trial of TRC105 in combination with Avastin and carboplatin and paclitaxel chemotherapy in patients with non-squamous non-small cell lung cancer who have not received prior Avastin or systemic chemotherapy. Approximately 18 patients are expected to enroll in the study and top-line data are expected in 2017.

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 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 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

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop TRC105, the expected size and timing of the Phase 1b clinical trial of TRC105 in lung cancer, expectations regarding the initiation and timing of future clinical trials by TRACON, and expected development milestones. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact:
Casey Logan
Chief Business Officer
(858) 550‐0780 ext. 236
[email protected]

Investor Contact:
Andrew McDonald
LifeSci Advisors LLC
646-597-6987
[email protected]