MAIA Biotechnology Unveils New Data on THIO’s Efficacy in Non-Small Cell Lung Cancer

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical enterprise, has unveiled new efficacy data from its Phase 2 clinical trial, THIO-101, focusing on the investigational anti-cancer drug THIO coupled with the immune checkpoint inhibitor cemiplimab (Libtayo®). The trial targets patients with advanced non-small cell lung cancer (NSCLC) who have not responded to at least two prior standard-of-care treatments. The updated results were shared at the American Society of Clinical Oncology's (ASCO) 2024 Annual Meeting, revealing promising outcomes.

The latest data from the THIO-101 trial indicate an overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% in third-line treatment for patients administered THIO and cemiplimab. This is particularly significant given the historical DCR range of 25-35% and ORR of 6-10% in similar patient populations undergoing chemotherapy.

Key findings from the trial include:
- An 85% DCR for THIO in contrast to the standard chemotherapy range of 25-35%.
- 65% of participants exceeded the 5.8-month overall survival (OS) benchmark.
- 85% surpassed the 2.5-month progression-free survival (PFS) threshold.
- The median survival follow-up currently stands at 9.1 months, based on data from 20 patients.

In third-line treatments utilizing a THIO dosage of 180mg, the optimal dose determined in the study, additional outcomes were noted:
- A median PFS of 5.5 months.
- A 78% OS rate at the six-month mark.
- 75% of patients surpassed the 5.8-month OS threshold.
- 88% of patients exceeded the 2.5-month PFS benchmark.
- The median survival follow-up is also 9.1 months for this cohort of 8 patients.

Dr. Vlad Vitoc, Chairman and CEO of MAIA Biotechnology, expressed enthusiasm about the trial results. He highlighted that the efficacy measures exceeded expectations and outperformed existing standard-of-care treatments. The company anticipates receiving comprehensive efficacy data from the THIO-101 trial in the latter half of the year.

The THIO-101 trial completed full enrollment earlier than planned on February 19, 2024. The results to date indicate that the combination of THIO and cemiplimab is generally well-tolerated among heavily pre-treated patients. THIO is a first-in-class telomere-targeting agent that modifies telomeric DNA, triggers DNA damage responses, and leads to selective cancer cell death. Sequential treatment with THIO followed by PD-(L)1 inhibitors like cemiplimab has shown significant and sustained tumor regression in advanced cancer models.

MAIA Biotechnology is committed to the development and commercialization of novel cancer therapies with a focus on improving patient outcomes. THIO, their leading program, targets telomerase-positive cancer cells and is under clinical development for NSCLC, particularly for those who have exhausted other treatment options. The ongoing THIO-101 Phase 2 trial aims to validate THIO's efficacy and its potential to enhance immune response when used in conjunction with checkpoint inhibitors.

The trial is designed to assess two primary objectives: evaluating the safety and tolerability of THIO as an anticancer agent and immune system primer, and determining its clinical efficacy by measuring the ORR. The promising interim results underscore THIO's potential as a viable treatment option for advanced NSCLC patients who have not benefited from existing therapies.