MAIA Biotechnology Receives FDA Clearance for Investigational New Drug Application for THIO-101 Clinical Study

MAIA Biotechnology, a clinical-stage company specializing in telomere-targeting immunotherapies for cancer, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for THIO. This clearance allows MAIA to evaluate THIO in the U.S. as part of its ongoing global phase 2 clinical study, THIO-101, in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The IND clearance represents a significant milestone for MAIA, as it expands the reach of THIO’s clinical development as a first-in-class telomere-targeting agent for patients with advanced NSCLC. THIO is being tested in combination with Regeneron’s anti-PD-1 monoclonal antibody cemiplimab (Libtayo®) to assess its anti-tumor activity and immune response in NSCLC patients.

Vlad Vitoc, MAIA’s Chief Executive Officer, expressed his satisfaction with the FDA clearance, stating, “We are extremely pleased to obtain clearance to extend our go-to-market THIO-101 trial to the U.S. and further develop THIO’s global reach.” Mihail Obrocea, M.D., MAIA’s Chief Medical Officer, also emphasized the significance of the FDA IND clearance in the clinical development of THIO.

MAIA worked closely with the FDA throughout the pre-IND/IND process to align with regulatory guidance and recommendations. The company remains committed to developing safe and effective treatments for patients with cancer, as highlighted by K. Robinson Lewis, MAIA’s Head of Regulatory and Quality.

THIO (6-thio-dG or 6-thio-2′-deoxyguanosine) is a first-in-class investigational telomere-targeting agent that induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. The sequential treatment of THIO followed by PD-(L)1 inhibitors has shown promising results in advanced cancer models, leading to tumor regression and the induction of cancer type-specific immune memory.

The ongoing THIO-101 clinical trial is a multicenter, open-label, dose-finding phase 2 study. It aims to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial’s primary objectives are to assess the safety and tolerability of THIO as an anticancer compound and a priming immune activator, as well as to evaluate its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint.

MAIA Biotechnology is dedicated to the development and commercialization of potential first-in-class drugs with novel mechanisms of action to improve and extend the lives of cancer patients. Their lead program, THIO, is a potential breakthrough cancer telomere-targeting agent for the treatment of NSCLC patients with telomerase-positive cancer cells.

For more information about MAIA Biotechnology and their ongoing clinical trials, please visit www.maiabiotech.com.