MAIA Biotechnology Doses First U.S. Patient in Phase 2 NSCLC Trial

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, has achieved a significant milestone in its ongoing Phase 2 clinical trial. The first U.S. patient has been dosed in the trial, which is evaluating the company’s lead candidate, ateganosine, in third-line non-small cell lung cancer (NSCLC) patients.

The U.S. expansion of the trial is funded by a $2.3 million grant from the National Institutes of Health (NIH) to support the evaluation of third-line treatment. MAIA has activated three sites in the U.S. to participate in the trial, which is part of the THIO-101 program. This program aims to assess the safety and efficacy of ateganosine when used in combination with cemiplimab (Libtayo®), a programmed death-ligand 1 (PD-L1) inhibitor.

Ateganosine, a dual mechanism therapy, is designed to break down telomere structure and function in cancer cells while inducing immune activation. The modified nucleotide 6-thio-2’-deoxyguanosine, which is ateganosine, induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. This process results in the accumulation of telomeric fragments in cytosolic micronuclei, which activates both innate and adaptive immune responses.

Prior data from THIO-101 Parts A and B show promising results, with overall survival (OS) beyond 24 months in eight patients who received ateganosine sequenced with a checkpoint inhibitor. The current Phase 2 trial is the first to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is designed to test the hypothesis that low doses of ateganosine, administered prior to cemiplimab, will enhance and prolong the immune response in patients with advanced NSCLC who have progressed beyond the standard-of-care regimen.

The trial, known as THIO-101, is a multicenter, open-label, dose-finding Phase 2 clinical trial. It aims to evaluate the safety and tolerability of ateganosine and assess its clinical efficacy using overall response rate (ORR) as the primary clinical endpoint. The expansion of the study will specifically assess ORR in advanced NSCLC patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy.

Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, expressed excitement about the milestone. "Our collaborations with some of the nation’s top institutions and foremost oncologists further strengthen the trial as we evaluate ateganosine for patients in advanced stages of this exceedingly hard-to-treat disease. We believe the data generated through the THIO-101 program may also support a potential pathway toward FDA accelerated approval."

The company holds FDA Fast Track designation for ateganosine, which is currently in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. The THIO-101 Phase 2 trial is part of a global effort to address a critical unmet need in cancer care, with patients now enrolled across four continents.

The THIO-101 Phase 2 clinical trial is registered on ClinicalTrials.gov with the identifier NCT05208944. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab will enhance and prolong the immune response in patients with advanced NSCLC who have progressed beyond the standard-of-care regimen.

With the dosing of the first U.S. patient, MAIA Biotechnology, Inc. is taking a significant step toward advancing its innovative cancer therapy and potentially improving the lives of patients with advanced NSCLC.