On April 11, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported positive topline data from the completed Part A safety lead-in of the Company’s THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and has commenced recruitment in Part B randomized efficacy/dose selection (Press release, MAIA Biotechnology, APR 11, 2023, View Source [SID1234629981]).
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Topline data from Part A demonstrated that MAIA’s telomere-targeting agent, THIO, administered in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), were generally well-tolerated. No dose-limiting toxicities (DLTs) or significant treatment-related adverse events were observed.
Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients. Mild toxicities, such as grade 1 fatigue, and muscle pain, were reported, as well as only one occurrence of grade 3 nausea, but no grade 4 adverse events, reported.
"Part A’s safety profile is in sharp contrast with the typical safety profile of chemotherapy treatment where 70-80% of NSCLC patients experience grade 3 and 4 toxicities," said MAIA’s Chief Medical Officer Mihail Obrocea, M.D. "The next dose levels of THIO in Part B are lower compared to Part A. Based on the initial safety profile seen at the highest dose in Part A, we are optimistic about the safety profile of THIO."
"We are pleased with the completion of the safety lead-in portion, which is a very important milestone and catalyst that marks the continued progression of our Phase 2 THIO-101 trial. Recruitment has commenced in the Part B efficacy/dose selection portion of our go-to-market trial, and we anticipate reporting preliminary efficacy data later this year," said MAIA’s Chairman and Chief Executive Officer Vlad Vitoc, M.D.
Part B of the study will allow randomization of patients to three THIO dose levels, including 60 mg, 180 mg and 360 mg, followed by cemiplimab treatment every 3 weeks. Safety and tolerability will continue to be monitored across all THIO doses. The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.
THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial designed to evaluate THIO’s potential direct anticancer and immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), thus 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 anti-cancer and priming immune system agent followed by cemiplimab administration, as well as preliminary clinical efficacy of THIO in patients with advanced NSCLC, who either progressed or relapsed through the initial treatments 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. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About Toxicity Grading in Cancer Treatments
Toxicity is graded 0-5. Toxicity of grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death.
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-PD-1 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.