Novel Telomere-Targeting Therapy for Advanced Non-Small Cell Lung Cancer

Summary: With non-small cell lung cancer (NSCLC) persisting as a leading cause of cancer mortality worldwide and resistant to many standard treatments, MAIA Biotechnology, Inc. is focused on developing THIO, a novel therapeutic agent aimed at improving treatment outcomes in patients with advanced-stage NSCLC. THIO, a direct telomere targeting agent, is designed to exploit the vulnerability of cancer cells’ telomerase-dependency, offering a new avenue for therapeutic intervention in cases where existing options fail. To address the limited efficacy and resistance issues associated with current NSCLC treatments, our objective is to evaluate the safety and efficacy of THIO in combination with the immune checkpoint inhibitor cemiplimab in a multicenter, open- label, single-arm Phase 2 clinical study. The study will enroll subjects with stage 3 or 4 NSCLC who have shown resistance to prior checkpoint inhibitors, utilizing THIO's mechanism of causing tumor cell death by incorporation into telomeres and inducing instability. This Phase 2 clinical trial follows promising preclinical and early clinical results where THIO showed high selectivity in killing telomerase-active cancer cells and significant synergy with immune checkpoint inhibitors. Given the high incidence of NSCLC and the significant portion of patients lacking effective treatment options, the successful development of THIO could dramatically enhance quality of life and survival rates by providing a new, effective treatment modality. This project not only addresses an urgent public health need but also advances our understanding of cancer biology and treatment, potentially offering broader implications for other telomerase-positive cancers. Project Number: 1R44CA309843-01 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Victor Zaporojan | Institution: MAIA BIOTECHNOLOGY, INC., CHICAGO, IL | Award Amount: $770,168 | Activity Code: R44 | Study Section: Special Emphasis Panel[ZRG1 CTH-V (10)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11311784