MAIA Biotechnology Inc. (NYSE: MAIA) has announced encouraging interim results from its phase 2 clinical trial of THIO, a novel therapy targeting advanced non-small cell lung cancer (NSCLC). The study, known as THIO-101, is evaluating THIO in combination with Regeneron Pharmaceuticals Inc.’s immune checkpoint inhibitor cemiplimab (Libtayo®) in patients who have failed two or more standard-of-care therapy regimens.
The interim data reveals promising survival benefits, with 16 patients having survival follow-ups exceeding 12 months, including 9 patients in their third line of treatment. The interim median survival follow-up in third-line patients was 10.6 months, with three of the earliest enrolled patients approaching 17-month survival benefits. These results are particularly significant given the typically poor prognosis for advanced NSCLC patients who have exhausted multiple treatment options.
NSCLC is the most prevalent form of lung cancer in the United States, accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is only 28%, underscoring the urgent need for more effective treatments. THIO’s mechanism of action targets telomeres, which play a crucial role in cancer cell survival and proliferation. By inducing telomerase-dependent telomeric DNA modification, THIO triggers DNA damage responses and selective cancer cell death.
The positive interim survival data aligns with previously reported efficacy results from the THIO-101 trial. In June, MAIA presented data at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, showing 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 for THIO in combination with cemiplimab in third-line treatment.
Dr. Vlad Vitoc, Chairman and Chief Executive Officer of MAIA, expressed optimism about the results, stating, ‘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.’
The potential impact of THIO extends beyond NSCLC. MAIA plans to explore its use in treating other forms of cancer, including hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and malignant gliomas. The U.S. FDA has already granted Orphan Drug Designation to THIO for these indications, highlighting its potential significance in addressing unmet medical needs.
As the global cancer treatment market is projected to reach $521 billion by 2033, growing at a compound annual growth rate of 8.9% from 2023 to 2033, MAIA’s progress with THIO could position the company as a significant player in the oncology field. The full efficacy data from the THIO-101 trial is expected in the second half of this year, which may provide further insights into the treatment’s potential and its impact on patient outcomes.
The development of THIO represents a promising step forward in the fight against advanced NSCLC and potentially other difficult-to-treat cancers. As research continues and more data becomes available, the medical community and patients alike will be watching closely to see if THIO can deliver on its early promise and offer new hope in the challenging landscape of cancer treatment.
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