MAIA Biotechnology to Present at AACR Annual Meeting 2023

Rhea-AI Summary

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced its participation in the AACR Annual Meeting 2023 where it will present a poster detailing its ongoing Phase 2 clinical trial, THIO-101, for patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The presentation will occur on April 17, 2023, during the session titled "Phase II and Phase III Clinical Trials in Progress". The primary goals of the THIO-101 trial are to assess the safety and tolerability of THIO, as well as its efficacy using Overall Response Rate as the primary endpoint. This trial represents a significant advancement in evaluating THIO's effectiveness in NSCLC patients who have previously shown resistance to treatments.

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced that it will present a poster that will feature the design of its ongoing Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The poster will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, which is taking place in-person at the Orange County Convention Center in Orlando, Florida from April 14-19, 2023.

Details on the poster and the corresponding abstract are shown below.

Poster Title: A phase 2, multi-center, open-label, dose-finding study evaluating telomere targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC
Session Title: Phase II and Phase III Clinical Trials in Progress
Abstract Number: CT050 / 8
Session Date: Monday, April 17, 2023, 9:00 am to 12:30 pm ET
Speaker/Lead Author: Mihail Obrocea, MD, MAIA’s Chief Medical Officer

Clinical trial abstract texts will be published online on AACR’s Online Itinerary Planner at 12:00 pm ET on April 14, 2023.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor 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 another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (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.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Its lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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Investor Inquiries

MAIA Biotechnology

Joseph McGuire

Chief Financial Officer

jmcguire@maiabiotech.com

904-228-2603

ICR Westwicke

Stephanie Carrington

Stephanie.carrington@westwicke.com

646-277-1282

Source: MAIA Biotechnology, Inc.

FAQ

What is the focus of MAIA's Phase 2 clinical trial THIO-101?

The THIO-101 trial focuses on evaluating THIO's potential immune system activation effects in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

When will MAIA present its research at the AACR Annual Meeting?

MAIA will present its poster on April 17, 2023, at the AACR Annual Meeting in Orlando, Florida.

What are the primary objectives of the THIO-101 trial?

The primary objectives are to evaluate the safety and tolerability of THIO and to assess its clinical efficacy using Overall Response Rate as the main endpoint.

Who is the lead author for the poster presentation at AACR?

The lead author for the poster presentation is Dr. Mihail Obrocea, MAIA's Chief Medical Officer.

What is THIO and its significance in cancer treatment?

THIO (6-thio-dG) is an investigational telomere-targeting agent being developed to enhance treatment outcomes for NSCLC patients who have progressed beyond standard therapies.