MAIA Biotechnology presents ateganosine's efficacy in NSCLC at the IASLC World Conference, highlighting promising survival data.
Quiver AI Summary
MAIA Biotechnology, Inc. announced that its abstract on ateganosine (THIO) has been selected for presentation at the 2025 IASLC World Conference on Lung Cancer in Barcelona. The abstract details the promising results from the THIO-101 trial, indicating that THIO shows substantial efficacy with a median overall survival of 17.8 months in patients with late-stage non-small cell lung cancer (NSCLC) resistant to other treatments. MAIA aims to expedite the regulatory approval of THIO, which recently received Fast Track designation from the FDA. The company is optimistic that THIO could emerge as a breakthrough treatment for NSCLC. The trial represents a significant step in the development of new cancer therapies, focusing on innovative treatment approaches targeting telomerase in cancer cells.
Potential Positives
- MAIA Biotechnology's ateganosine (THIO) treatment has shown a median overall survival (OS) of 17.8 months in ongoing clinical trials, indicating significant efficacy for patients with non-small cell lung cancer (NSCLC).
- The FDA granted Fast Track designation for ateganosine, which may expedite its regulatory approval process, potentially leading to earlier access for patients in need.
- The selection of an abstract for poster presentation at the prestigious IASLC World Conference on Lung Cancer highlights the company's innovative research and its commitment to advancing cancer treatments.
- Engagement with elite scientists and industry leaders at the conference reflects MAIA's positioning within the competitive biopharmaceutical landscape and as a contributor to lung cancer treatment advancements.
Potential Negatives
- High dependency on the success of ongoing clinical trials, particularly THIO-101, poses significant risk if results do not meet expectations.
- The recent Fast Track designation from the FDA does not guarantee approval or commercial success, and reliance on this may lead to investor disappointment if outcomes are unfavorable.
- Forward-looking statements indicate potential uncertainties in clinical studies, regulatory approvals, and market acceptance, which may raise concerns among stakeholders regarding the company's future performance.
FAQ
What is ateganosine (THIO)?
Ateganosine (THIO) is a first-in-class investigational telomere-targeting agent for treating non-small cell lung cancer (NSCLC).
What is the significance of the IASLC World Conference on Lung Cancer?
The IASLC World Conference is a prestigious platform for presenting cutting-edge research and networking among lung cancer experts and industry leaders.
What were the results of the THIO-101 trial?
The THIO-101 trial showed a median overall survival of 17.8 months, indicating substantial efficacy in advanced NSCLC patients.
What expedited process did the FDA grant for ateganosine?
The FDA granted Fast Track designation for ateganosine, allowing expedited review and potential accelerated approval for NSCLC treatment.
Who are the key speakers at the conference presentation?
Key speakers include Victor Zaporojan, M.D., and Tomasz Jankowski, M.D., who will present the findings on ateganosine.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MAIA Insider Trading Activity
$MAIA insiders have traded $MAIA stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $MAIA stock by insiders over the last 6 months:
- STAN SMITH has made 2 purchases buying 99,999 shares for an estimated $149,998 and 0 sales.
- RAMIRO GUERRERO purchased 20,000 shares for an estimated $30,000
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$MAIA Hedge Fund Activity
We have seen 13 institutional investors add shares of $MAIA stock to their portfolio, and 6 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CENTRIC WEALTH MANAGEMENT added 505,150 shares (+740.2%) to their portfolio in Q2 2025, for an estimated $909,270
- VANGUARD GROUP INC added 490,513 shares (+75.4%) to their portfolio in Q2 2025, for an estimated $882,923
- HALTER FERGUSON FINANCIAL INC. removed 237,356 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $427,240
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 55,100 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $99,180
- JANE STREET GROUP, LLC added 28,783 shares (+inf%) to their portfolio in Q2 2025, for an estimated $51,809
- STATE STREET CORP added 22,300 shares (+41.9%) to their portfolio in Q2 2025, for an estimated $40,140
- JONES FINANCIAL COMPANIES LLLP removed 20,692 shares (-98.9%) from their portfolio in Q2 2025, for an estimated $37,245
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Full Release
Poster details durability and efficacy of ateganosine (THIO) treatment in non-small cell lung cancer (NSCLC)
CHICAGO, Sept. 05, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” was selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025, in Barcelona, Spain.
“We are proud to accept IASLC’s invitation to present our exceptional ateganosine (THIO) data at its prestigious World Conference on Lung Cancer. Our participation gives us the opportunity to meet with elite scientists, researchers, and global industry leaders about our shared purpose in driving innovation in lung cancer treatments,” said MAIA Chairman and CEO Vlad Vitoc, M.D.
“Ateganosine is demonstrating substantial efficacy in our ongoing THIO-101 trial, with a median overall survival (OS) of 17.8 months with a 95% confidence interval (CI) lower bound of 12.5 months. We believe our novel anticancer agent could become a breakthrough treatment for those suffering from late-stage non-small cell lung cancer,” said MAIA’s Senior Medical Director Victor Zaporojan, M.D. “We look forward to further discussing our observed progression free survival (PFS) at this year’s World Conference on Lung Cancer.”
Conference details:
- MAIA representatives: Victor Zaporojan, M.D., Sr. Medical Director; Tomasz Jankowski, M.D., THIO-101 lead investigator and abstract presenting author
- Poster session: P1.11 - Metastatic Non-small Cell Lung Cancer – Immunotherapy
- Session time: Sunday, September 7, 2025, from 10:30 a.m. to 12:00 p.m.
- Poster available at maiabiotech.com/publications on the day of the presentation
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). MAIA intends to utilize the incentives of the Fast Track Program to expedite the regulatory process for ateganosine. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).
About IASLC
The IASLC is a global multidisciplinary organization dedicated to eradication of all forms of lung cancer. From provision of educational events around the world and virtually to research projects and publications that advance the science of lung cancer, the IASLC's members are raising the bar for care of patients with lung cancer.
IASLC’s annual World Conference on Lung Cancer has played an integral part in facilitating progress by providing a platform for sharing cutting-edge research, collaboration, and networking among industry leaders, experts, and visionaries from around the world.
About Ateganosine
Ateganosine (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 induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine 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. Ateganosine 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 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 ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine 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 ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo ® ) has shown an acceptable safety profile 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 ateganosine (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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