FDA Approves MAIA Biotechnology's Telomerase Inhibitor Therapy
CHICAGO-- MAIA Biotechnology, Inc. (NYSE American: MAIA), a company at the clinical stage of developing immunotherapies aimed at telomeres for cancer treatment, has spotlighted the validation of clinical and regulatory pathways for therapies utilizing cellular telomeric functions. This validation is exemplified by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a therapy for low to intermediate-risk hematologic malignancies such as myelodysplastic syndromes, developed by Geron Corporation.
Dr. Vlad Vitoc, Chairman and CEO of MAIA, expressed enthusiasm over the FDA's approval of imetelstat. He emphasized the pioneering role MAIA has played in exploring telomere targeting as a therapeutic strategy. "We have determined that telomere targeting is crucial in treating certain cancers," Vitoc stated. He also mentioned that MAIA is currently conducting a Phase 2 trial of their leading candidate, THIO, for high-risk non-small cell lung cancer (NSCLC).
Telomerase, an enzyme present in over 85% of human cancers, is instrumental in the unchecked growth and reproductive immortality of cancer cells. MAIA's THIO is designed to exploit this by incorporating into the telomeres of cancer cells. Once integrated, THIO disrupts the telomere structure and function, leading to the "uncapping" of chromosome ends, which in turn results in the rapid death of tumor cells.
About THIO
THIO, or 6-thio-2’-deoxyguanosine, is an innovative investigational agent that targets telomeres. In the context of NSCLC, THIO modifies telomeric DNA in a manner dependent on telomerase, triggering DNA damage responses and selectively inducing cancer cell death. The damaged telomeric fragments from THIO accumulate in cytosolic micronuclei, thereby activating innate (cGAS/STING) and adaptive (T-cell) immune responses. Sequential treatment involving THIO followed by PD-(L)1 inhibitors has shown significant and lasting tumor regression in advanced cancer models by inducing immune memory specific to cancer types. THIO is currently being developed as a second or later line of treatment for NSCLC patients who have not responded to standard checkpoint inhibitors.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is an open-label, multicenter, dose-finding Phase 2 clinical trial. This trial is the first designed to examine the anti-tumor activity of THIO when used in conjunction with PD-(L)1 inhibition. The trial hypothesizes that administering low doses of THIO before cemiplimab (Libtayo®) could enhance and prolong the immune response in patients with advanced NSCLC who have not responded to or have developed resistance to first-line treatments involving other checkpoint inhibitors. The primary objectives of this trial are twofold: to evaluate the safety and tolerability of THIO as an anticancer agent and immune activator, and to assess its clinical efficacy through the Overall Response Rate (ORR). Thus far, treatment with cemiplimab followed by THIO has been well-tolerated in heavily pre-treated populations. More information about this Phase II trial can be found on ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA Biotechnology, Inc. focuses on developing and commercializing targeted therapy and immuno-oncology drugs with novel mechanisms of action. Their primary program involves THIO, a potential groundbreaking cancer telomere targeting agent currently in clinical development for treating NSCLC patients with telomerase-positive cancer cells.
This breakthrough highlights the critical role of telomere targeting in cancer therapy, reinforcing the potential for innovative treatments that improve and extend the lives of cancer patients.
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