TRACON Pharmaceuticals Expands License Agreement and Signs Research Agreement With Case Western Reserve University

Agreement Strengthens Intellectual Property Estate Around TRC102 and Provides Opportunity for Development of Additional Predictive Biomarkers


SAN DIEGO, April 8, 2015 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, announced today that it entered into an amended license agreement and a new sponsored research collaboration with Case Western Reserve University (CWRU).

The amended agreement strengthens the intellectual property estate around TRC102 by including additional issued patents and patent applications covering combinations of TRC102 with certain approved chemotherapeutic agents as well as patents covering the use of biomarkers that may be used to predict which patients are most likely to respond to TRC102 treatment. In addition, TRACON and CWRU have entered into a sponsored research agreement whereby CWRU will further assess biomarkers that may predict the activity of regimens combining TRC102 with chemotherapeutics, including Alimta® (pemetrexed).

"We are happy to expand our productive partnership with Case Western Reserve University and look forward to their continued support of our TRC102 clinical development program," noted Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We believe that this partnership, along with our collaboration with the National Cancer Institute, will help maximize TRC102's potential to reverse resistance to chemotherapy, a characteristic that could improve outcomes of patients with lung cancer, brain cancer as well as other malignancies."

About TRC102

TRC102 is a novel, clinical stage small molecule inhibitor of the DNA base excision repair pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in clinical trials sponsored by both the National Cancer Institute and Case Comprehensive Cancer Center.  For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.

TRC102 was discovered by Stanton L. Gerson, M.D., the Asa and Patricia Shiverick-Jane Shiverick (Tripp) Professor of Hematological Oncology and Associate Dean of Oncology at Case Western Reserve University School of Medicine.  Gerson is also director of the NCI-designated Case Comprehensive Cancer Center, the National Center for Regenerative Medicine and the Seidman Cancer Center at University Hospitals Case Medical Center. 

About TRACON

TRACON develops targeted therapies for cancer, age-related macular degeneration and fibrotic diseases. TRACON's current pipeline includes two clinical stage product candidates: TRC105, an anti-endoglin antibody that is being developed for the treatment of renal cell carcinoma, soft tissue sarcoma, hepatocellular carcinoma, glioblastoma and choriocarcinoma, and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. Both TRC105 and TRC102 are being developed for treatment in combination with currently available therapies. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.

About Case Comprehensive Cancer Center

Case Comprehensive Cancer Center is an NCI-designated Comprehensive Cancer Center located at Case Western Reserve University.  The center, which has been continuously funded since 1987, integrates the cancer research activities of the largest biomedical research and health care institutions in Ohio – Case Western Reserve, University Hospitals (UH) Case Medical Center and the Cleveland Clinic. NCI-designated cancer centers are characterized by scientific excellence and the capability to integrate a diversity of research approaches to focus on the problem of cancer (http://cancer.case.edu).

About Case Western Reserve University School of Medicine

Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health.  The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching.  The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century.  Nine Nobel Laureates have been affiliated with the School of Medicine. 

Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report's "Guide to Graduate Education."

The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002 (http://casemed.case.edu).

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 and Case Western's plans to further develop TRC102 and evaluate potential biomarkers, and the potential benefits of TRC102.  Risks that could cause actual results to differ from those expressed in these forward-looking statements include: risks associated with clinical development and biomarker discovery; whether TRACON will be able to complete or initiate clinical trials on its expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful; whether expected research under the sponsored research agreement with Case Western will proceed on the parties' expected timelines or at all, potential changes in regulatory requirements in the United States and foreign countries; TRACON's reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture 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.



            

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