MAIA Biotechnology's THIO Shows Promising Interim Results in Phase 2 NSCLC Study

MAIA Biotechnology Inc. (NYSE: MAIA), a clinical-stage biopharmaceutical company, has announced positive interim survival benefits from its Phase 2 study of THIO for advanced non-small cell lung cancer (NSCLC). This form of lung cancer is the most prevalent in the U.S., making up 81% of lung cancer diagnoses with a five-year survival rate of only 28%.

In the THIO-101 Phase 2 clinical trial, MAIA is evaluating THIO in combination with Regeneron Pharmaceuticals Inc.'s (NASDAQ: REGN) immune checkpoint inhibitor cemiplimab (Libtayo®) in patients who have not responded to two or more standard-of-care treatments. As of August, 16 patients had exceeded 12 months of survival follow-up, with nine of these patients in their third line of treatment. The interim median survival follow-up for third-line patients was 10.6 months, with some early enrollees nearing 17 months of survival benefits.

“THIO is showing a survival benefit for patients with advanced NSCLC. We’re on track to achieve our survival goals in third-line therapy,” said Vlad Vitoc, M.D., Chairman and CEO of MAIA. “THIO’s outperformance to date supports our thesis that our telomere targeting agent could become a treatment option for people suffering from advanced NSCLC.”

THIO targets and attacks telomeres, which play a crucial role in the survival and proliferation of cancer cells. Telomerase, which protects chromosome ends, is usually active during early human development but is present in nearly all cancers, allowing cells to divide and spread. Over 80% of NSCLC tumors show telomerase expression, making this a significant target for THIO.

The 12-month survival data aligns with earlier findings from the THIO-101 study, demonstrating favorable disease control and overall response rates. In June, MAIA presented new efficacy data showing an overall response rate (ORR) of 38%, a disease control rate (DCR) of 85%, and a median progression-free survival (PFS) of 5.5 months in third-line treatment. These data were shared at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” noted Vitoc. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”

If THIO proves effective, MAIA plans to expand its use to other forms of cancer, including hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and malignant gliomas. These indications have already received Orphan Drug Designation from the U.S. FDA. With the cancer treatment market expected to reach $521 billion by 2033, MAIA's developments could have significant implications for future cancer therapies.

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