MAIA Biotechnology Reports Updates on Disease Control Rates for THIO-101 Phase 2 Trial for Advanced Non-Small Cell Lung Cancer

Rhea-AI Summary

MAIA Biotechnology (NYSE American: MAIA) has reported promising updates on disease control data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial. The trial is evaluating THIO in sequential combination with cemiplimab for patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have previously failed 2 or more prior lines of treatment.

Key findings include:

• 82% disease control rate: 9 out of 11 patients with post-baseline scans met the primary endpoint of disease control
• Disease control is defined as Complete Response, Partial Response, or Stable Disease per RECIST 1.1
• All patients had previously failed immune checkpoint inhibitor (CPI) and platinum-based chemotherapy treatments
• No new safety analysis was conducted at this time

The company's CEO, Vlad Vitoc, expressed encouragement with these preliminary results, noting that they align with pre-clinical data showing THIO's potential to enhance CPI effectiveness in resistant cases.

Positive

• 82% disease control rate observed in heavily pre-treated NSCLC patients
• Preliminary data aligns with pre-clinical results showing THIO's potential to enhance CPI effectiveness
• No new safety concerns reported at this time

Negative

• Small sample size of only 11 patients with post-baseline scans
• Results are preliminary and require further monitoring for longer-term efficacy

• Of the first 11 patients with post-baseline scans, 9 met the disease control primary endpoint at first response assessment.

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced updates on disease control data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

Of the first 11 patients enrolled in THIO-101 to complete at least 1 post baseline response assessment, 9 (82%) met the primary endpoint of disease control (defined as a Complete Response, Partial Response, or Stable Disease per RECIST 1.1). All patients enrolled have previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at this time.

“The 82% disease control rate observed so far with this combination is highly encouraging, especially in the heavily pre-treated population with previous immune CPI resistance, where typically the Disease Control Rates are in the 25-35% range. This preliminary data aligns with our pre-clinical data which showed that THIO, followed by an immune checkpoint inhibitor, greatly slowed and reduced tumor progression when compared to treatment with CPI alone. We look forward to continue the monitoring of these patients and evaluate disease control rates on a longer time frame with the next response assessment phases,” said Vlad Vitoc, MAIA’s Chief Executive Officer.

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 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. THIO is being 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 potential immune system activation effects in NSCLC patients by administering THIO in sequential combination with Regeneron’s anti-PD1 therapy, Libtayo® (cemiplimab), 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 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.

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Investor Inquiries

MAIA Biotechnology

Joseph McGuire

Chief Financial Officer

jmcguire@maiabiotech.com

904-228-2603

Investor Relations

ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

FAQ

What are the latest results from MAIA Biotechnology's THIO-101 Phase 2 trial for NSCLC?

MAIA Biotechnology reported that 9 out of 11 patients (82%) with post-baseline scans met the primary endpoint of disease control in the Part A safety lead-in of the THIO-101 phase 2 trial for advanced Non-Small Cell Lung Cancer.

How does the 82% disease control rate in MAIA's THIO-101 trial compare to typical rates?

The 82% disease control rate is considered highly encouraging, as typical Disease Control Rates in heavily pre-treated populations with previous immune checkpoint inhibitor resistance are in the 25-35% range.

What is the significance of MAIA's THIO-101 trial results for NSCLC treatment?

The preliminary results suggest that THIO, when used in sequential combination with cemiplimab, may be effective in controlling disease progression in advanced NSCLC patients who have failed previous treatments, including immune checkpoint inhibitors and chemotherapy.

What are the next steps for MAIA Biotechnology's THIO-101 trial (MAIA stock symbol)?

MAIA Biotechnology plans to continue monitoring the patients and evaluate disease control rates over a longer time frame with subsequent response assessment phases. This will provide more comprehensive data on the efficacy of the THIO and cemiplimab combination treatment.