TRACON Announces FDA Orphan Drug Designation for TRC102 in Malignant Glioma, Including Glioblastoma
TRC102 is being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the
“Orphan drug designation for TRC102 underscores the high level of unmet medical need in patients with malignant glioma and supports its potential in this indication based on the previously reported data demonstrating prolonged survival in patients retreated with Temodar combined with TRC102,” said James Freddo, M.D, Chief Medical Officer of TRACON. “We remain committed to developing TRC102 in collaboration with the
The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the
About TRC102
TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the
About Malignant Glioma and GBM
GBM (also called glioblastoma) is a fast-growing malignant glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. The
About TRACON
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma in a registrational trial in the
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 the National Cancer Institute’s plans to further develop product candidates, the potential benefits of orphan drug designation for TRC102, expectations regarding clinical trials, 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 expected timelines, if at all, including due to risks associated with the COVID-19 pandemic or other pandemics; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; whether the expected benefits of orphan drug designation will ultimately be realized, including due to potential loss of orphan drug designation or the development of competing products; potential changes in regulatory requirements in
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Source: TRACON Pharmaceuticals, Inc.