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By Mangeet Kaur Bouns

Lung cancer remains the top cause of cancer-related deaths in the U.S., accounting for approximately 20% of all cancer fatalities. The American Cancer Society's projections for 2024 highlight the gravity of this issue, with an estimated 234,580 new lung cancer cases and about 125,070 deaths anticipated in the U.S. Of these, nearly 80% to 85% are non-small cell lung cancer (NSCLC) cases, highlighting the urgent need for effective treatments.

MAIA Biotechnology, Inc. (AMEX: MAIA), a clinical-stage biopharmaceutical company focused on developing telomere-targeting immunotherapies for cancer treatment, has unveiled promising new clinical data showcasing the efficacy of its lead product candidate, THIO, in treating NSCLC. This data emerges from a phase 2 clinical trial evaluating THIO in combination with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo), targeting patients with advanced NSCLC who have not responded to at least two standard-of-care therapies.

In the context of NSCLC, where traditional treatments often fall short, THIO's potential as a first-in-class telomere-targeting agent raises hope. Its ability to disrupt cancer cell telomeres and stimulate immune responses marks a significant advancement in the fight against this devastating disease.

MAIAs Lead Candidate: THIO

THIO is a groundbreaking telomere-targeting agent, currently undergoing phase 2 clinical trials aimed at treating NSCLC with telomerase-positive cancer cells. Telomerase, present in over 85% of human cancers, plays a crucial role in the immortality and proliferation of cancer cells. THIO integrates into telomeres within these cells, disrupting their structure and function leading to rapid tumor cell death.

By inducing telomerase-dependent DNA modification and damage, THIO triggers selective cancer cell death. This process accumulates telomeric damage in cytosolic micronuclei, which then activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. In in vivo cancer models, sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in significant and sustained tumor regression, fostering cancer-specific immune memory.

Key Findings From The Phase 2 THIO-101 Clinical Trial

The phase 2 THIO-101 trial primarily focuses on assessing the safety and tolerability of THIO both as an anticancer agent and as an immune system activator, alongside evaluating its clinical efficacy through overall response rate (ORR).

The trial results are noteworthy. The disease control rate (DCR) for THIO in combination with CPI was 85%, far exceeding the 25-35% DCR typically seen with chemotherapy in third-line treatments. Additionally, 65% of patients surpassed the 5.8-month overall survival (OS) threshold, and 85% exceeded the 2.5-month progression-free survival (PFS) threshold, demonstrating significant clinical benefits. The median survival follow-up time stood at 9.1 months for the cohort of 20 patients.

Optimal dose selection yielded even more impressive outcomes. Patients in third-line receiving 180mg of THIO exhibited a median PFS of 5.5 months, a 75% OS rate at six months and an ORR of 38%, compared to the standard 6-10% ORR for chemotherapy. Notably, 75% of these patients crossed the 5.8-month OS threshold and 88% surpassed the 2.5-month PFS threshold, with a median survival follow-up time of 9.1 months among the eight patients assessed.

Implications And Future Directions

Dr. Vlad Vitoc, chairman and CEO of MAIA, expressed enthusiasm about the trial outcomes, noting, "All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard-of-care treatments." He emphasized THIOs potential as a robust, safe and highly effective alternative for patients who have not benefited from chemotherapy and other treatments.

The THIO-101 trial, which completed enrollment ahead of schedule in February, reached its target of 41 patients for the 180 mg dose. This data, which indicates promising disease control and overall response rates, paves the way for further investigation and potential redefinition of cancer treatment protocols.

As THIO-101 data continues to demonstrate favorable disease control and response rates, with full efficacy data anticipated in the latter half of this year, MAIA Biotechnology stands poised to redefine cancer treatment. THIOs promise to transform the standard of care in oncology offers new hope to patients with advanced NSCLC, potentially establishing a new benchmark in cancer therapy.

Featured photo by CI Photos at Shutterstock.

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