On April 26, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to THIO, a telomere-targeting agent currently in development to evaluate its activity in multiple cancer indications, for the treatment of hepatocellular carcinoma (HCC) (Press release, MAIA Biotechnology, APR 26, 2022, View Source [SID1234612987]).

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"Receipt of Orphan Drug Designation for THIO is an important milestone for MAIA," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "The designation provides further momentum for the THIO program, which we are committed to advancing as quickly as possible for patients in need, like those living with HCC."

"Patients living with HCC currently have limited treatment options that are often ineffective. After completing standard-of-care therapy, patients with HCC tend to have poor outcomes with little to no improvement from treatment," said Mihail Obrocea, M.D., Chief Medical Officer of MAIA. "The FDA’s decision to grant ODD to THIO is an important recognition of MAIA’s unique scientific approach of telomere-targeting and the potential we have with THIO to deliver a first-in-class oncology drug to patients."

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA, added, "We are pleased to have received ODD from the FDA for THIO since we have been preparing for clinical studies to evaluate the ability of THIO to enhance and extend the immune system’s response to fight cancer. We look forward to continuing to advance THIO and to dosing our first patient in the upcoming Phase 2 studies."

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.