MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, has announced that a late-breaking abstract from its Phase 2 THIO-101 clinical trial has been selected for presentation at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The conference will take place from November 6-10, 2024, in Houston, Texas. The abstract will provide new data on the efficacy and safety of THIO, an investigational telomere-targeting agent, when used in combination with Regeneron’s immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who have previously failed two or more standard-of-care treatments.
Vlad Vitoc, M.D., Chairman and CEO of MAIA, expressed the significance of being recognized by SITC in such an esteemed category, highlighting that their latest data supports THIO’s potential to generate cancer cell-specific immune memory and maintain activity against cancer cells over prolonged periods. This is particularly relevant for advanced-stage patients resistant to current CPI and chemotherapy treatments, underlining the promise of THIO in combination with a CPI as a durable and effective treatment for NSCLC.
The presentation, titled "Telomere-Targeting Agent THIO in Sequential Combination with Cemiplimab Demonstrates Long-Term Therapeutic Benefits Beyond Treatment Cessation — A Phase 2 Trial in Advanced Immune Checkpoint Inhibitor Resistant Non-Small Cell Lung Cancer Patients," will be delivered by Victor Zaporojan, M.D., Senior Medical Director at MAIA. This session is scheduled for November 8, 2024, from 11:45 a.m. to 12:15 p.m. CST.
As of August 1, 2024, the THIO-101 trial had 16 patients with survival follow-up surpassing 12 months, nine of whom were in the third line of treatment. The interim median survival follow-up in the third line was reported at 10.6 months, a significant improvement over the current standard-of-care overall survival of 5.8 months for similar patient groups.
THIO (6-thio-dG) is a first-in-class investigational agent targeting telomeres, which are critical for cancer cell survival and resistance to existing treatments. THIO induces telomerase-dependent modifications in telomeric DNA, leading to DNA damage responses and selective cancer cell death. It also activates both innate and adaptive immune responses, which contribute to its anti-cancer effects. Preclinical models have shown that sequential treatment with THIO followed by PD-(L)1 inhibitors can result in significant and long-lasting tumor regression, creating a cancer type-specific immune memory. Currently, THIO is being investigated as a second or later line of treatment for NSCLC patients who have progressed beyond standard-of-care therapies.
The THIO-101 Phase 2 clinical trial is designed as a multicenter, open-label, dose-finding study to evaluate the anti-tumor activity of THIO followed by PD-(L)1 inhibition. The primary objectives are to assess the safety and tolerability of THIO and its clinical efficacy using the Overall Response Rate (ORR) as the primary endpoint. Early results suggest that the combination of THIO and cemiplimab is generally well-tolerated among heavily pre-treated patients.
MAIA Biotechnology, Inc. specializes in developing and commercializing novel therapeutic agents with unique mechanisms of action aimed at improving and extending the lives of cancer patients. Their leading program, THIO, is currently in clinical development for treating NSCLC with telomerase-positive cancer cells.
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