MAIA Biotechnology Reports Favorable Phase 2 Results for NSCLC Agent with 2024 Milestones

MAIA Biotechnology, a biopharmaceutical firm, has reported promising interim results from its Phase 2 clinical trial of THIO-101 for non-small cell lung cancer (NSCLC). The study, which combines THIO with Libtayo®, has shown sustained disease control in 60 patients dosed, with 42 having completed at least one post-baseline assessment. Vlad Vitoc, MAIA’s CEO, highlighted the impressive disease control and response rates, which surpass standard treatments.

Entering 2024, MAIA is poised with a strong clinical pipeline targeting various challenging cancers. The company's immuno-oncology therapy portfolio has received a third orphan drug designation for THIO, targeting glioblastoma, an aggressive brain cancer with limited treatment options. Additionally, the U.S. FDA has granted clearance for THIO's evaluation in the THIO-101 trial, which has seen robust enrollment.

A pivotal achievement was the selection of a 180mg/cycle dose of THIO for the THIO-101 trial, which demonstrated superior efficacy and disease control compared to other dosages. Furthermore, MAIA is advancing its second-generation telomere-targeting agents, aiming to enhance specificity to cancer cells and boost anticancer activity.

THIO is distinguished as the sole direct telomere-targeting agent in clinical development for cancer. It operates by inducing telomerase-dependent telomeric DNA alterations, triggering DNA damage responses and selective cancer cell death. The compound also activates innate and adaptive immune responses, leading to significant tumor regression when followed by PD-(L)1 inhibitors in advanced cancer models.

The THIO-101 trial is a significant Phase 2 study, testing the hypothesis that low doses of THIO can enhance and prolong the immune response in NSCLC patients who have not responded to or have become resistant to first-line checkpoint inhibitors. The trial's primary objectives are to evaluate THIO's safety, tolerability, and clinical efficacy, with an emphasis on the Overall Response Rate as the main clinical endpoint.

MAIA is dedicated to developing and commercializing innovative drugs that could significantly improve the lives of cancer patients. The company's lead program, THIO, is a potential first-in-class cancer telomere-targeting agent undergoing clinical development for NSCLC patients with telomerase-positive cancer cells.