MAIA Biotechnology Announces Dose Selection in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer
MAIA Biotechnology, Inc. (NYSE American: MAIA) announced the selection of a dose for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in combination with Regeneron’s anti-PD-1 cemiplimab in patients with advanced non-small cell lung cancer (NSCLC). The selected dose of 180mg/cycle showed better safety profile and outperformed other doses in efficacy measures, exceeding disease control rate thresholds and showing promising preliminary response rates. MAIA plans to pursue accelerated approval for THIO in the U.S. for the treatment of advanced NSCLC patients, believing in its potential to define the standard of care for this patient population.
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Selected dose of 180mg/cycle showed better safety profile and outperformed other doses in efficacy measures
Results suggest potential for accelerated approval for THIO in the U.S. for the treatment of advanced NSCLC patients
The selection of an optimal dose in a Phase 2 clinical trial for a novel cancer treatment is a critical milestone, particularly when it demonstrates favorable safety and efficacy profiles. In the context of MAIA Biotechnology's THIO-101 trial, the choice of 180mg per cycle of THIO, in combination with cemiplimab, reflects a strategic balance between minimizing adverse effects and maximizing therapeutic benefit for advanced NSCLC patients.
Advanced NSCLC represents a challenging therapeutic area with a high unmet need, especially for patients who have become resistant to first-line treatments. The reported disease control rates (DCR) and overall response rates (ORR) suggest that THIO could potentially shift the treatment paradigm, offering a new avenue for those who have exhausted other options. It is important to consider, however, that these results are preliminary and should be interpreted with caution until further data from larger cohorts are available.
From a clinical perspective, the fact that THIO is the only direct telomere targeting agent in development is noteworthy. Telomeres play a crucial role in cellular aging and cancer progression and targeting them could represent a significant advancement in oncology. The potential for accelerated approval indicates confidence in the data but also underscores the need for continued rigorous evaluation of long-term outcomes and side effects.
MAIA Biotechnology's announcement regarding the dose selection for its lead asset THIO carries substantial implications for its valuation and investor sentiment. The positive preliminary data from the THIO-101 trial could act as a catalyst for the company's stock performance on the NYSE American. The mention of pursuing accelerated approval in the U.S. is particularly significant, as it may lead to a shorter time-to-market and could be a strong driver for future revenue growth.
Investors should be aware of the inherent risks associated with clinical-stage biopharmaceutical companies. While the data is promising, the regulatory pathway is fraught with challenges and the actual market potential of THIO will depend on several factors, including the final trial results, competitive landscape, pricing, reimbursement issues and market penetration strategies. Furthermore, MAIA's financial health, burn rate and funding for ongoing trials must be scrutinized to assess the company's capacity to bring THIO to market without significant dilution to current shareholders.
Given that NSCLC is a prevalent form of cancer with substantial market size, a successful entry of THIO could disrupt the current standard of care and capture a significant market share. However, investors should diversify their portfolios to mitigate the risk associated with the binary outcomes of clinical trials.
The development of THIO as a direct telomere targeting agent is a pioneering step in the field of cancer therapeutics. The dose selection based on safety and efficacy is a testament to the rigorous R&D process that aims to optimize therapeutic outcomes. The reported efficacy of the 180mg dose of THIO in a population resistant to immune checkpoint inhibitors is particularly significant, as it addresses a gap in the current treatment landscape for advanced NSCLC.
Drug resistance is a major hurdle in cancer treatment and the ability of THIO to exhibit control in such a patient population is indicative of its novel mechanism of action. This could open up research into other cancer types where telomere dynamics play a central role. However, it's crucial to continue monitoring the long-term effects of telomere targeting, as it may have implications on normal cell function and aging.
As the clinical trial progresses, it will be important to analyze the broader impact of THIO on patient quality of life, overall survival and its integration into existing treatment protocols. The pharmaceutical industry and the medical community will be watching closely to see if the results hold up in larger, more diverse patient populations and how THIO compares to other emerging treatments in the pipeline.
12/19/2023 - 07:00 AM
Selected dose shows unprecedented disease control and overall response rates in a NSCLC clinical trial
CHICAGO --(BUSINESS WIRE)--
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo® ) in patients with advanced non-small cell lung cancer (NSCLC).
During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo® ). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials. Subsequently, all future trial participants will be treated with THIO 180mg/cycle.
“All THIO dose levels tested exceeded the disease control rate (DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, beating our goal of disease control in 8 out of 19 patients per arm. Among the three studied doses, the 180mg dose showed stronger DCR and preliminary response rates compared to other doses,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.
“These results are particularly impressive in this pool of patients who were heavily pre-treated and resistant to prior treatments with immune checkpoint inhibitors, a group that does not yet have standard of care treatment. We are highly encouraged by the unprecedented clinical data generated thus far in our Phase 2 trial, and as we move forward, we plan to pursue accelerated approval for THIO in the U.S. for the treatment of patients with advanced NSCLC. We believe THIO’s DCRs and ORRs in second line treatment suggest the drug’s potential to define the standard of care for this NSCLC patient population.”
THIO is the only direct telomere targeting agent currently undergoing clinical development 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 cemiplimab (Libtayo® ) followed by THIO 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.
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Investor Relations Contact
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Source: MAIA Biotechnology, Inc.
What is the company name and ticker symbol for the biopharmaceutical company developing telomere-targeting immunotherapies for cancer?
MAIA Biotechnology, Inc. (NYSE American: MAIA)
What is the Phase 2 clinical trial evaluating THIO in combination with Regeneron’s anti-PD-1 cemiplimab focused on?
The Phase 2 clinical trial is focused on evaluating THIO in combination with Regeneron’s anti-PD-1 cemiplimab in patients with advanced non-small cell lung cancer (NSCLC)
What dose was selected for THIO-101 trial and why?
The selected dose of 180mg/cycle showed better safety profile and outperformed other doses in efficacy measures, exceeding disease control rate thresholds and showing promising preliminary response rates
What are the plans for THIO in the U.S. based on the trial results?
MAIA plans to pursue accelerated approval for THIO in the U.S. for the treatment of advanced NSCLC patients, believing in its potential to define the standard of care for this patient population
