MAIA Biotechnology Doses First Patients in Europe in Ongoing Phase 2 Trial (THIO-101) Evaluating THIO for Non-Small Cell Lung Cancer Treatment

Rhea-AI Summary

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced the dosing of the first two patients in its Phase 2 trial, THIO-101, in Europe for advanced Non-Small Cell Lung Cancer (NSCLC). The trial aims to assess the safety, tolerability, and preliminary efficacy of THIO, a novel telomere-targeting agent. Following clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated. The trial commenced in Australia in July 2022 and in Europe in March 2023. The primary endpoint is Overall Response Rate (ORR), with data expected later this year, providing a potential treatment avenue for patients with high unmet needs.

Positive

• First two patients dosed in Europe for Phase 2 trial THIO-101.
• Five clinical sites activated in Hungary, Poland, and Bulgaria.
• Potential to address high unmet need in NSCLC treatment.

Negative

• None.

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc. (NYSE American: MAIA) announced today that the first two patients have been dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). Following regulatory clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated in these three European countries.

The primary objectives of the THIO-101 trial are to evaluate the safety and tolerability, as well as preliminary clinical efficacy of THIO, a first-in-class cancer telomere targeting agent, in patients with advanced NSCLC, who either progressed or relapsed through the initial treatments with an immune checkpoint inhibitor alone, or in combination with chemotherapy. The Company dosed its first patient in the THIO-101 trial in Australia in July 2022 and commenced dosing patients in Europe in March 2023.

“We are very excited to commence enrolling patients in Europe in THIO-101 as five sites are being activated in three countries. THIO represents a potential treatment for patients with Non-Small Cell Lung Cancer, which currently has limited treatment options and continues to be defined by high unmet need and mortality,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are very pleased with the progress we have made thus far as we are now enrolling patients in Australia and three European countries in this ongoing Phase 2 trial with THIO.”

Mihail Obrocea, MD, MAIA’s Chief Medical Officer, added, “The initiation of dosing in MAIA’s Phase 2 clinical trial of THIO-101 in Europe depicts important progress for MAIA towards understanding the pharmacokinetics and safety of this first-in-class investigational medicine, and we very much look forward to potentially sharing the clinical data later this year."

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. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in development for the treatment of patients with telomerase-positive cancers. 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

ICR Westwicke

Stephanie Carrington

Stephanie.carrington@westwicke.com

646-277-1282

Source: MAIA Biotechnology, Inc.

FAQ

What is MAIA's THIO-101 clinical trial about?

THIO-101 is a Phase 2 clinical trial evaluating the safety and preliminary efficacy of THIO in advanced Non-Small Cell Lung Cancer patients.

When did MAIA start dosing patients in Europe for THIO-101?

Dosing in Europe for THIO-101 began in March 2023.

What are the primary objectives of THIO-101?

The primary objectives are to evaluate the safety and tolerability of THIO, as well as its preliminary clinical efficacy.

What is the significance of the THIO drug in cancer treatment?

THIO is a first-in-class telomere-targeting agent designed to improve treatment options for NSCLC patients who have progressed on existing therapies.

What can investors expect from the THIO-101 trial results?

Investors can anticipate potential clinical data release later this year, which may impact the stock's performance.