On October 19, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported that preliminary safety and efficacy data from its ongoing Phase 2 clinical trial, THIO-101, was accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, being held in Madrid, Spain, October 20-24, 2023 (Press release, MAIA Biotechnology, OCT 19, 2023, View Source [SID1234636159]). THIO-101 is evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo).

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"We look forward to presenting THIO data at the esteemed ESMO (Free ESMO Whitepaper) Congress, where we will have the opportunity to update global leaders in cancer research from around the world on the only direct telomere targeting agent currently in clinical development," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA Biotechnology.

The abstract is available online at the ESMO (Free ESMO Whitepaper) Congress website, and MAIA is scheduled for poster presentation on Monday, October 23. Details of the presentation are as follows:

Abstract title: A Phase 2, Multi-Center, Open-Label, Dose-Optimization Study Evaluating Telomere Targeting Agent THIO Sequenced with Cemiplimab in Patients with Advanced NSCLC – Preliminary Results

Presenter: Tomasz Jankowski, M.D.

Presentation Number: 1493P

Session title: NSCLC, metastatic

About ESMO (Free ESMO Whitepaper) and the ESPO Congress

The European Society for Medical Oncology is the leading professional organization for medical oncology. With more than 30,000 members representing oncology professionals from 168 countries worldwide, ESMO (Free ESMO Whitepaper) is the society of reference for oncology education and information.

The ESMO (Free ESMO Whitepaper) Congress is one of the most influential oncology platforms for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. Only the highest quality studies are approved to be presented, supporting dissemination of the latest cutting-edge data, high quality education and unparalleled networking opportunities for oncologists and other stakeholders from all around the world.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for patients with advanced NSCLC who progressed after first line treatment regimens containing an immune check point inhibitor.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron’s anti-PD-1 cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.