MAIA Biotechnology to Present New Phase 2 Clinical Trial Data at the H.C. Wainwright 26th Annual Global Investment Conference

Rhea-AI Summary

MAIA Biotechnology (NYSE American: MAIA) will present new Phase 2 clinical trial data for its lead candidate THIO at the H.C. Wainwright 26th Annual Global Investment Conference in September 2024. The presentation will focus on the THIO-101 trial, which combines THIO with the immune checkpoint inhibitor cemiplimab for advanced non-small cell lung cancer (NSCLC) patients who have failed multiple standard treatments.

Key highlights include:

• Presentation scheduled for September 10, 2024, at 08:00 am ET
• Updates on response rates and survival follow-up
• THIO's mechanism as a telomere-targeting agent with direct DNA damage and immune response induction
• Exceptional efficacy demonstrated in NSCLC to date
• Long-term efficacy results expected before year-end

THIO-101 is anticipated to be the first completed clinical study of a telomere-targeting agent in cancer treatment.

Positive

• Phase 2 clinical trial data for THIO in advanced NSCLC showing exceptional efficacy
• Presentation at a major investment conference, potentially increasing visibility
• THIO-101 expected to be the first completed clinical study of a telomere-targeting agent in cancer treatment
• Long-term efficacy results expected before year-end, potentially providing significant data

Negative

• THIO is still in clinical trials, with no guarantee of regulatory approval or commercial success
• Focus on patients who have failed multiple standard treatments, indicating a potentially initial market

• Updates from THIO-101 to include response rates and survival follow-up

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that Chairman and Chief Executive Officer Vlad Vitoc, M.D. will present at the H.C. Wainwright & Co. 26th Annual Global Investment Conference taking place September 9–11, 2024, in New York City.

Dr. Vitoc’s presentation will reveal the latest clinical data from MAIA’s Phase 2 THIO-101 clinical trial of lead candidate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens.

Conference details:

MAIA live presentation:	Tuesday, September 10, 2024, at 08:00 am ET*
Live webcast:	Join here.
Conference location:	Lotte New York Palace, New York City
Conference registration:	Available on the conference website.
1-on-1 meetings:	Requests available upon registration.
Presentation slides:	ir.maiabiotech.com under Company Info: Presentations
*Please note that the presentation date and time are subject to change. Participants should refer to H.C. Wainwright’s final program agenda for up-to-date information.

THIO is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101’s treatment results to date have demonstrated exceptional efficacy in NSCLC, the most prevalent tumor type by mortality. Long-term efficacy results are expected before year-end. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

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 advanced, 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 NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a 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 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 another 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. Treatment with THIO followed by Regeneron’s cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240904363254/en/

Investor Relations Contact

+1 (872) 270-3518

ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

FAQ

What is MAIA Biotechnology's stock symbol?

MAIA Biotechnology's stock symbol is MAIA, listed on the NYSE American exchange.

When will MAIA present new Phase 2 data for THIO-101?

MAIA will present new Phase 2 data for THIO-101 on September 10, 2024, at the H.C. Wainwright 26th Annual Global Investment Conference.

What type of cancer is THIO being tested for in the THIO-101 trial?

THIO is being tested for advanced non-small cell lung cancer (NSCLC) in patients who have failed two or more standard-of-care therapy regimens.

How does MAIA's lead candidate THIO work?

THIO is a small molecule telomere-targeting anticancer agent that produces direct telomeric DNA damage and induces cancer-specific immune responses.

When are long-term efficacy results for THIO-101 expected?

Long-term efficacy results for THIO-101 are expected before the end of 2024.