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FDA Approval Confirms the Effectiveness of MAIA Biotechnology's Telomere Targeting Therapy with a Telomerase Inhibitor

Saturday, June 08, 2024

MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage firm focused on creating telomere-targeting immunotherapies for cancer, has affirmed the clinical and regulatory pathways for treatments that exploit the cell's telomeric functions. This development follows the FDA's approval of imetelstat by Geron Corporation for treating low- to intermediate-risk hematologic malignancies, such as myelodysplastic syndromes.

Vlad Vitoc, M.D., Chairman and CEO of MAIA, commented, “MAIA is at the forefront of telomere-targeting therapy, and we are thrilled with the FDA's approval of imetelstat for rare blood cancers originating in the bone marrow. Our Phase 2 trial of THIO in high-risk non-small cell lung cancer (NSCLC) has demonstrated significant efficacy in patients who are resistant to checkpoint inhibitors and chemotherapy. We applaud Geron for their pioneering efforts.”

Telomerase is present in over 85% of human cancers, playing a critical role in the proliferation and immortality of cancer cells. MAIA's primary investigational candidate, THIO, is a telomere-targeting agent currently undergoing clinical trials (Phase 2 THIO-101) to evaluate its effectiveness in NSCLC. THIO interacts with telomerase and becomes integrated into the telomeres of cancer cells, disrupting their structure and function, which leads to the 'uncapping' of chromosome ends and the rapid death of tumor cells.

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a groundbreaking investigational telomere-targeting agent being evaluated in clinical studies for its potential to treat Non-Small Cell Lung Cancer (NSCLC). Telomeres and the enzyme telomerase are essential for the survival and resistance of cancer cells. THIO induces modifications to telomeric DNA through a telomerase-dependent mechanism, triggering DNA damage responses and selectively inducing the death of cancer cells. This process results in the accumulation of damaged telomeric fragments in cytosolic micronuclei, activating both innate (cGAS/STING) and adaptive (T-cell) immune responses. When administered sequentially with PD-(L)1 inhibitors, THIO has shown substantial and sustained tumor regression in advanced in vivo cancer models by fostering cancer-specific immune memory. THIO is being developed as a treatment option for NSCLC patients who have advanced beyond initial treatments with existing checkpoint inhibitors.

THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial designed to evaluate THIO’s anti-tumor activity when used in conjunction with PD-(L)1 inhibition. The study investigates whether low doses of THIO administered before cemiplimab (Libtayo®) can enhance and extend the immune response in advanced NSCLC patients who have not responded to or have developed resistance after a first-line treatment regimen with another checkpoint inhibitor. The trial has two primary objectives: (1) to evaluate the safety and tolerability of THIO as both an anticancer compound and a priming immune activator, and (2) to assess the clinical efficacy of THIO, with Overall Response Rate (ORR) as the primary endpoint. Initial treatments with cemiplimab followed by THIO have been generally well-tolerated in this heavily pre-treated patient population. For more information about this Phase II trial, please visit and use the identifier NCT05208944.



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