MAIA Biotechnology Announces Publication in Nature Communications on Positive Effects of THIO for Potential Treatment of Small Cell Lung Cancer
- Extensive preclinical studies for THIO in SCLC were published in Nature Communications.
- THIO demonstrates immune-enhancing and metastasis-reducing effects in in vitro and in vivo models of SCLC.
- The unique dual mechanism of action for THIO as a telomere-targeted anticancer agent is highlighted.
- THIO has been awarded orphan drug designation (ODD) by the FDA for SCLC treatment.
- The company has entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers.
- None.
Insights
The recent findings on MAIA Biotechnology's lead candidate THIO present a significant advancement in the treatment of small cell lung cancer (SCLC). THIO's dual mechanism of action, which involves telomere targeting and immune response activation, is particularly noteworthy. The activation of the type-I interferon pathway through cGAS-STING signaling could represent a paradigm shift in SCLC therapeutics, a field that has seen limited innovation over the years.
Given the high prevalence of telomerase activity in SCLC, the telomere-targeting approach could be highly specific and effective. The depletion of cancer initiating cells (CICs) and the reduction in metastatic potential could translate into improved survival rates for patients, who currently have few treatment options. The combination of THIO with ionizing radiation also suggests a potential for synergistic treatment regimens, which could enhance efficacy while possibly reducing side effects compared to traditional chemotherapy.
The Orphan Drug Designation (ODD) awarded to THIO by the FDA is a critical milestone for MAIA Biotechnology. This status not only acknowledges the unmet medical need in SCLC but also provides MAIA with incentives such as tax credits, user fee waivers and potential market exclusivity upon approval. From a research perspective, the preclinical data showing THIO's effectiveness in both in vitro and in vivo models is promising and supports the progression to a Phase 2 clinical trial.
The implications for stakeholders are substantial. If THIO proves effective in clinical trials, it could lead to a new standard of care in SCLC treatment. For investors, the progression to Phase 2 trials is a pivotal moment that could affect MAIA's stock valuation positively, reflecting the advancement of the drug candidate through the development pipeline.
MAIA Biotechnology's advancement of THIO into Phase 2 planning stages is a significant development that could impact the company's financial trajectory. The ODD grants financial benefits that can reduce the cost burden of clinical trials, which is crucial for a clinical-stage biopharmaceutical company. Moreover, the potential for seven years of market exclusivity in the U.S could allow MAIA to capitalize on first-mover advantage and secure a substantial market share if THIO is approved.
Investors should note the inherent risks associated with clinical-stage biopharmaceutical investments, including the possibility of trial failures, regulatory hurdles and competition from other drugs. However, the successful development of THIO could lead to considerable long-term returns, given the high mortality rate and limited treatment options for SCLC. The stock market often reacts favorably to positive clinical trial results and regulatory milestones such as ODD, which could make MAIA an attractive stock for those interested in the biotech sector.
- THIO treatment leads to profound activation of innate and adaptive anti-tumor responses
- THIO depletes cancer initiating cells (CICs) and thus diminishes tumor initiation and metastasis-forming potential in various in vivo models
- THIO previously awarded orphan drug designation (ODD) by FDA for small cell lung cancer (SCLC) treatment
“This publication highlights a rather unique dual mechanism of action for THIO as a first-in-clinic telomere-targeted anticancer agent for potential treatment of SCLC,” said Sergei M. Gryaznov, PhD., MAIA’s Chief Scientific Officer. “In addition to the direct and potent cancer cell depletion activity, the observed specific interferons stimulation, immune responses-enhancement, and metastasis-reducing effects of THIO provide solid scientific foundation for further advancement of this compound in clinical development.”
A prominent characteristic of lung cancer small cells is their reliance on telomerase activity, a key enzyme essential for the continuous proliferation of SCLC. While 85
Key findings in the published paper include:
- Human and mouse SCLC lines are sensitive to THIO (6TdG) treatment in vitro and in vivo
- THIO decreases cancer initiating cells and diminishes tumor initiation potential in vitro and in vivo
- Low doses of THIO are effective in treating metastatic mouse SCLC tumors
- THIO activates type-I interferon pathway through cGAS-STING signaling
- THIO is highly effective in combination with ionizing radiation treatment regiments
“With few, if any, effective treatments for small cell lung cancer, there is a widespread need for innovative therapeutic strategies. The positive outcomes reported in our publication show THIO’s potential as a new therapeutic approach,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO already holds Orphan Drug Designation for SCLC, underscoring the FDA’s recognition of THIO’s potential to improve outcomes for this highly lethal disease. With the positive preclinical and clinical data we have obtained to date for THIO, we have entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers.”
Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the
About the Publication
Nature Communications, volume 15, article number: 672 (2024), “A telomere-targeting drug depletes cancer initiating cells and promotes anti-tumor immunity in small cell lung cancer,” published 22 January 2024. Co-author disclosures included in manuscript.
About Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for
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 nucleoside 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 activating 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 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
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1 Hiyama, K. et al. Telomerase activity in small-cell and non-small-cell lung cancers. J Natl Cancer Inst 87, 895-902, doi:10.1093/jnci/87.12.895 (1995).
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FAQ
What is the lead candidate for small cell lung cancer described in the publication?
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What designation has THIO been awarded by the FDA for SCLC treatment?
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