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TRACON Doses First Patient in Phase 1b Study of TRC105 with Opdivo® in Patients with Lung Cancer

SAN DIEGO, Nov. 29, 2017 (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 (AMD) and fibrotic diseases, announced today that the first patient has been dosed in its Phase 1b clinical trial of TRC105 in combination with Opdivo® (nivolumab) in patients with non-small cell lung cancer.

“Endoglin is expressed on activated myeloid derived suppressor cells, a cell type implicated in tumor resistance to immunotherapy. To date, we have observed promising signs of activity with our endoglin antibodies in combination with PD-1 inhibitors in a number of preclinical syngeneic mouse tumor models,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are excited to advance a combination of TRC105 with an immune oncology agent into the clinic to further assess our antibody’s immunomodulatory activity.”

About the Phase 1b Clinical Trial of TRC105 and Opdivo in Lung Cancer

The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when given with Opdivo, determine its recommended Phase 2 dose with Opdivo and evaluate the response rate. The trial incorporates tumor biopsy testing to correlate tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy of lung cancer patients.

Further details of the study are available on www.clinicaltrials.gov, identifier NCT03181308.

About Carotuximab (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 the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at 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: 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.; TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule that is being developed for the treatment of prostate cancer. 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 TRACON’s plans with respect to the Phase 1b clinical trial of TRC105 and Opdivo and potential benefits of a combination of TRC105 with Opdivo. 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, the fact that results of clinical trials may not be consistent with results of prior studies, TRACON’s ability to identify and enroll patients in clinical trials, potential delays in completing clinical trials, whether TRACON’s product candidates will be shown to be safe and effective in subsequent studies, and TRACON’s ability to fund additional clinical development of TRACON’s product candidates. 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 

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TRACON Pharmaceuticals, Inc.