MAIA Biotechnology Expands Clinical Supply Agreement with Regeneron for Phase 2 Non-Small Cell Lung Cancer Trial

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing targeted cancer immunotherapies, has announced an amendment to its 2021 clinical supply agreement with Regeneron. This amendment pertains to the expansion phase of the THIO-101 Phase 2 clinical trial, which evaluates the sequential administration of THIO with cemiplimab (Libtayo®). This expansion aims to further scrutinize the effectiveness of MAIA’s leading asset, THIO, when used in combination with the immune checkpoint inhibitor Libtayo® for patients with advanced non-small cell lung cancer (NSCLC) who are receiving third-line treatment after showing resistance to previous checkpoint inhibitors and chemotherapy.

The initial 2021 agreement between MAIA and Regeneron was established to supply the THIO-101 trial throughout its dose selection and safety evaluation stages. The THIO-101 trial has now been modified and expanded to better assess efficacy at the target dose and in the third-line patient population.

Dr. Vlad Vitoc, Chairman and CEO of MAIA, expressed optimism about the continued collaboration with Regeneron to explore THIO's anti-tumor activity when followed by PD-(L)1 inhibition. According to Dr. Vitoc, the THIO-101 trial has shown promising outcomes in disease control, progression-free survival, and overall response rates, aligning with the company’s goals for overall survival.

As per the terms of the revised clinical supply agreement, MAIA will continue to sponsor the THIO-101 trial, while Regeneron will supply Libtayo® for treating all patients involved, including those in the newly added expansion phase. MAIA holds exclusive worldwide patent rights to develop and commercialize THIO and plans to start enrolling new patients in the expanded THIO-101 trial soon.

The company is also evaluating its regulatory strategies and believes there might be a chance for accelerated approval in the U.S., contingent on the final results of the ongoing THIO-101 trial.

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-of-its-kind investigational agent targeting telomeres, presently in clinical development for its potential effectiveness in treating Non-Small Cell Lung Cancer (NSCLC). Telomeres and the enzyme telomerase play crucial roles in the survival of cancer cells and their resistance to current treatments. THIO works by inducing telomerase-dependent modifications in telomeric DNA, triggering DNA damage responses and selective cancer cell death. Additionally, THIO-damaged telomeric fragments accumulate in cytosolic micronuclei, activating both innate and adaptive immune responses. When used sequentially with PD-(L)1 inhibitors, THIO has shown significant and lasting tumor regression in advanced cancer models by inducing cancer type-specific immune memory. THIO is currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond standard checkpoint inhibitor therapies.

The THIO-101 Phase 2 clinical trial is a multicenter, open-label, dose-finding study. It is the first trial designed to evaluate THIO's anti-tumor activity when administered before PD-(L)1 inhibition. The trial aims to test the hypothesis that low doses of THIO administered before cemiplimab (Libtayo®) can enhance and prolong the immune response in advanced NSCLC patients who did not respond or developed resistance to first-line checkpoint inhibitor treatments. The trial has two primary objectives: assessing the safety and tolerability of THIO as an anticancer compound and priming immune activator, and evaluating the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary endpoint. To date, treatment with THIO followed by cemiplimab (Libtayo®) has been well tolerated in a heavily pre-treated population.

MAIA Biotechnology, Inc. is dedicated to developing and commercializing innovative cancer therapies. Their lead program, THIO, is a potential first-in-class agent targeting telomeres in telomerase-positive cancer cells, currently in clinical development for NSCLC.