On December 20, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company") reported that it completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the planned U.S. expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, DEC 20, 2022, View Source [SID1234625467]). MAIA received positive feedback from the FDA regarding its manufacturing, preclinical and clinical development plan. MAIA also obtained guidance from the FDA on the assessment of its safety and efficacy in the THIO-101 Phase 2 trial that will be incorporated in the U.S. IND application. MAIA plans to file its U.S. IND in the first half of 2023 and commence enrolling patients in the U.S. in the second half of 2023.
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A pre-IND meeting provides an opportunity for open communication between a drug development company and the FDA to discuss the IND proposed filing and plan to obtain the agency’s guidance for the initial clinical studies of a novel drug candidate. The FDA reviewed the pre-IND package submitted by MAIA containing preclinical data, manufacturing and the Phase 2 clinical study protocol synopsis for THIO-101, provided guidance and recommendations, and addressed MAIA‘s questions on the initial development plan of THIO in the advanced NSCLC indication.
"We appreciate the FDA’s guidance as we prepare to file the IND application for our Phase 2 trial and open enrollment of patients in the U.S.," said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. "The successful completion of this engagement with the FDA is an important milestone that has helped provide regulatory direction with our planned THIO clinical development program."
THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab), allowing for immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as preliminary clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through the initial treatment with an immune-check point inhibitor alone or in combination with chemotherapy. The clinical trial is currently enrolling patients in Australia and the European Union as regulatory approvals have been received.
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), in sequential administration with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab). Telomeres 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.