MAIA Biotechnology Inc. (NYSE: MAIA), a clinical-stage biopharmaceutical company focused on targeted immunotherapies for cancer, has announced promising interim survival benefits from its Phase 2 study of THIO, its leading therapy for advanced non-small cell lung cancer (NSCLC). NSCLC is the predominant form of lung cancer in the U.S., accounting for 81% of diagnoses, with a five-year survival rate of only 28%.
The Phase 2 clinical trial, named THIO-101, evaluates the combination of THIO with Regeneron Pharmaceuticals Inc.’s (NASDAQ: REGN) immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced NSCLC who have not responded to at least two standard therapies. As of August, 16 patients showed survival follow-ups exceeding 12 months, including nine patients in their third line of treatment. The interim median survival for third-line patients was 10.6 months, with three of the earliest patients approaching 17 months of survival benefits.
Vlad Vitoc, M.D., Chairman and CEO of MAIA, stated, “THIO is showing a survival benefit for patients with advanced NSCLC. We’re on track to achieve our survival goals in third-line therapy. 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 telomeres, essential components in cancer cell division and spread. Telomerase, an enzyme composed of DNA sequences and proteins, caps and protects chromosomes. While telomerase is typically active during early human development and in a few adult cells, it is present in almost all cancers, facilitating cancer cell division and spread. Over 80% of NSCLC tumors exhibit telomerase expression. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death.
The 12-month survival data aligns with MAIA’s recent THIO-101 data, showing favorable disease control and overall response rates. In June, the company presented new efficacy data, revealing 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 from THIO + CPI in third-line treatment. These findings were shared in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024. The primary objectives of the THIO-101 Phase 2 trial are to assess THIO’s safety and tolerability as an anticancer drug and immune system primer, and to evaluate its clinical efficacy through ORR.
Vitoc commented, “All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments. 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.”
THIO shows promise not only for NSCLC but also for other cancers. If effective, MAIA plans to expand THIO’s use to hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and malignant gliomas, which have already been granted Orphan Drug Designation by the U.S. FDA. With the cancer treatment market projected to reach $521 billion by 2033, growing at a CAGR of 8.9% over 2023-2033, MAIA Biotechnology is a company to watch.
