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By Meg Flippin, Benzinga

MAIA Biotechnology Inc. (NYSE: MAIA), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted immunotherapies for cancer, reported positive interim survival benefits in a phase 2 study of THIO, its lead therapy to fight advanced non-small cell lung cancer (NSCLC). NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%.

In the phase 2 clinical trial dubbed THIO-101, MAIA is evaluating THIO sequenced with Regeneron Pharmaceuticals Inc.’s (NASDAQ: REGN) immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced NSCLC who failed two or more standard-of-care therapy regimens. As of August, 16 patients had survival follow-ups surpassing 12 months, including 9 patients in their third line of treatment. Interim median survival follow-up in third-line patients was 10.6 months. Three of the trials' earliest patients enrolled are nearing 17-month 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 Chief Executive Officer 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.”

Attacking Cancer Spreading Telomeres

THIO targets and attacks telomeres which play a key role in helping cancer cells live and spread. Telomerase is made from DNA sequences and proteins and sits at the end of chromosomes, capping and protecting them. Telomerase expression most often occurs in the early stages of growth and development in humans and in a few cells of adults. But in nearly all cancers, telomerase is present, allowing cancer cells to divide and spread. More than 80% of NSCLC tumors have telomerase expression. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death.

All The Data Coming Together

The 12-month survival data corresponds to MAIA’s most recent data from THIO-101 demonstrating favorable disease control and overall response rates. In June, the company presented new efficacy data that showed a favorable 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. The data was presented 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 examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer and to examine the clinical efficacy of THIO in the form of ORR.

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vitoc when the data was released. “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 seems to be showing promise in fighting one of the most common forms of lung cancer, but that’s not all. If this treatment proves effective, as the company believes, MAIA plans to use THIO in treating other forms of cancer, such as hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and malignant gliomas – indications to which THIO has been granted Orphan Drug Designation by the U.S. FDA. With the size of the cancer treatment market poised to hit $521 billion by 2033, growing at a CAGR of 8.9% over 2023-2033, MAIA may be one company to pay attention to.

Featured photo by motorolka on Shutterstock.

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