FDA Approval Validates MAIA Biotechnology’s Telomere-Targeting Therapy Using a Telomerase Inhibitor

MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage enterprise dedicated to developing telomere-targeting immunotherapies for cancer, has celebrated the validation of clinical and regulatory pathways for effective therapies leveraging the cell’s telomeric functions. This validation was underscored by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment targeting low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation.

“We are one of the early innovators in telomere targeting as a therapeutic strategy, and we’re thrilled about the FDA’s approval of imetelstat for rare blood cancers originating in bone marrow,” stated Vlad Vitoc, M.D., Chairman, and Chief Executive Officer of MAIA. “Telomere targeting shows promise in treating certain cancers, as demonstrated by our Phase 2 trial of THIO in high-risk non-small cell lung cancer (NSCLC). Recent clinical data indicates THIO’s remarkable efficacy in checkpoint inhibitor and chemo-resistant patients in NSCLC. We commend Geron for validating this pathway.”

Telomerase, found in over 85% of human cancers, significantly contributes to cancer cell proliferation and reproductive immortality. MAIA’s leading candidate, THIO, a telomere-targeting agent in clinical development (Phase 2 THIO-101), aims to assess its efficacy in NSCLC. THIO, recognized by telomerase, integrates into telomeres in cancer cells, compromising their structure and function, consequently leading to chromosome end ‘uncapping’ and rapid tumor cell death.

About THIO: THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) represents a pioneering investigational telomere-targeting agent currently undergoing clinical development for evaluation in Non-Small Cell Lung Cancer (NSCLC). Telomeres, in conjunction with telomerase, play a critical role in cancer cell survival and resistance to current treatments. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei, activating both innate (cGAS/STING) and adaptive (T-cell) immune responses. Sequential treatment with THIO followed by PD-(L)1 inhibitors has demonstrated profound and persistent tumor regression in advanced in vivo cancer models by inducing cancer type–specific immune memory. THIO is currently being developed as a second or later line of treatment for NSCLC in patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial: THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial. It represents the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial aims to test the hypothesis that low doses of THIO administered before cemiplimab (Libtayo®) will enhance and prolong the immune response in patients with advanced NSCLC who did not respond previously or developed resistance and progressed after a first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to assess the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to evaluate the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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