World News – AU – TRACON Announces Release of Clinical Data in Cancer Cells, Providing Molecular Insights into the Mechanism of Action of TRC102 and Patient Populations Most Likely to Respond to Treatment

SAN DIEGO, Nov. . Sep. 23, 2020 (GLOBE NEWSWIRE) – TRACON Pharmaceuticals (NASDAQ: TCON), a clinical-stage biopharmaceutical company focused on developing and commercializing novel targeted cancer therapeutics, leveraging a cost-effective, CRO-independent product development platform to engage with Ex-U. . S.. . Company for the development and marketing of innovative products in the USA. S.. . today announced the publication of clinical data that provides molecular insight into the mechanism of action of TRC102 and the patient populations most likely to respond to treatment. The article, entitled « Molecular Characteristics of Cancers Showing Exceptional Responses to Treatment, » sheds light on the clinical features and tumor biology of a patient with an exceptional responder treated with TRC102 at the National Cancer Institute (NCI): https: // www. Traconpharma. com / wp-content / uploads / 2020/11 / Can_Cell_2020_Nov_Mol_Analysis_ER. pdf

The patient was diagnosed with metastatic and highly refractory colon cancer and was on temozolomide (Temodar®) and TRC102. After treatment, the patient was considered an exceptional responder as the final follow-up had a nearly competitive response of 45 months. Detailed molecular analyzes of the patient’s tumor revealed a silencing of the DNA repair pathways, which may have led to a sensitivity to the inhibition of the DNA base excision repair pathway by TRC102. In particular, MGMT expression was silenced by promoter methylation and RAD50, a mediator of DNA double-strand break repair, was silenced by genetic mutation and loss of heterozygosity. The authors of the paper hypothesized that the combination of Temodar and TRC102 was effective because any necessary DNA repair pathways were compromised genetically or by the activity of TRC102. MGMT expression was also examined in biopsies from 11 colorectal patients who were subsequently enrolled in an expansion cohort, one of whom showed partial remission. The tumor associated with the partial response did not express MGMT, whereas each of the 10 tumors that did not respond to therapy robustly expressed this enzyme.

TRC102 is being investigated in several phase 1 and 2 clinical studies funded by the NCI as part of a research and development cooperation agreement. TRC102 was also evaluated in a Phase 2 study in combination with Temodar chemotherapy in 19 patients with progressive or recurrent glioblastoma who made progress after Temodar and external radiation therapy. Longer survival was observed in two patients over two years who both showed activation of the DNA base excision repair pathway and hyperactivation of DNA damage response genes prior to treatment with TRC102.

« Cancer Cell’s publication supports our belief that patients whose cancer depends on the DNA base excision repair pathway to repair DNA damage from chemotherapy may be particularly sensitive to the pharmacological effects of TRC102, » said James Freddo , M. . D.. . , Chief Medical Officer of TRACON. “The NCI data are also consistent with the results of the Phase 2 trial of Temodar and TRC102 in refractory glioblastoma. We remain committed to developing TRC102 in collaboration with the NCI and believe that the data generated so far provides a strong rationale for studying TRC102 in combination with Temodar and radiation therapy in newly diagnosed patients with malignant glioma. ”

TRC102 (methoxyamine) is a novel low molecular weight inhibitor in the clinical stage of the DNA base excisional repair pathway that causes resistance to alkylation and antimetabolite chemotherapeutic agents. TRC102 is currently being investigated in multiple Phase 1 and 2 clinical trials funded by the National Cancer Institute under a Research and Development Collaboration Agreement (CRADA). . TRC102 was designated an orphan drug by the US FDA for the treatment of malignant glioma in 2020. Further information on the clinical studies can be found on the TRACON website at www. Traconpharma. com / clinical trials.

GBM (also called glioblastoma) is a rapidly growing malignant glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of nerve cells in the brain. GBM is the most invasive type of glial tumor that grows rapidly and often spreads to nearby brain tissue. The National Cancer Institute estimates that around 22. 850 adults (12. 630 men and 10. 280 women) are diagnosed with brain and other cancers of the nervous system annually in the United States. S.. . and about 15. 320 of these diagnoses lead to death. GBM has an incidence of two to three in 100. 000 adults per year in the U. . S.. . and accounts for 52 percent of all primary brain tumors.

TRACON develops targeted cancer therapies using a capital-efficient, CRO-independent product development platform. The company’s clinical pipeline includes: Envafolimab, a subcutaneous PD-L1 single domain antibody being developed in a US registration study for the treatment of sarcomas. S.. . ;; TRC253, a phase 3 small molecule drug candidate for the treatment of prostate cancer; TRC102, a phase 2 small molecule drug candidate in development for the treatment of lung cancer and glioblastoma; and TJ004309, a phase 1 CD73 antibody in development for the treatment of advanced solid tumors. TRACON is actively looking for additional corporate partnerships through which U will lead. S.. . regulatory and clinical development and shares in the costs and risks of clinical development and leads U. . S.. . marketing. In these partnerships, TRACON believes it can serve as a solution for companies with no clinical and commercial skills in the United States. S.. . To find out more about TRACON and its product pipeline, visit the TRACON website at www. Traconpharma. com.

Statements 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 could differ materially from those expressed or implied in such forward-looking statements. These statements include, but are not limited to, statements regarding TRACON and the National Cancer Institute’s plans to further develop product candidates, clinical trial expectations, development and regulatory plans, the potential benefits of TRC102, and TRACON’s business development strategy and goals. 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 anticipated schedules, if at all, including due to risks associated with the COVID-19 pandemic or other pandemics; the fact that future preclinical and clinical studies may not be successful or otherwise agree with results from previous studies; the fact that TRACON has limited control over whether or when third-party employees complete ongoing studies, initiate additional studies, or obtain regulatory approval for TRACON product candidates; the fact that TRACON’s cooperation agreements must be terminated prematurely; whether TRACON will be able to conclude additional cooperation agreements on favorable terms or at all; possible changes in regulatory requirements in the US and abroad; TRACON’s trust in third parties in the development of its product candidates, including the conduct of its clinical studies and the manufacture of its product candidates; whether TRACON can obtain additional funding; and other risks described in the Risks filed by TRACON 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 are made and are based on the assumptions and estimates of management at that time. TRACON assumes no obligation to update such statements to reflect events or circumstances that occur after the date on which they were made.

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