MAIA Biotechnology Announces New Responder in Non-Small Cell Lung Cancer Phase 2 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 05 2025
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Should l Buy MAIA?
Source: Newsfilter
Clinical Trial Results: MAIA Biotechnology announced a partial response in a patient after 20 months of treatment with ateganosine (THIO) combined with Regeneron's cemiplimab for advanced non-small cell lung cancer, showcasing the treatment's efficacy and safety in heavily pretreated patients.
Future Developments: The company plans to expand its Phase 2 THIO-101 trial to further assess overall response rates in advanced NSCLC patients resistant to previous therapies, highlighting ateganosine as a potential alternative for third-line treatment.
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Analyst Views on MAIA
Wall Street analysts forecast MAIA stock price to rise
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Current: 1.970
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About MAIA
MAIA Biotechnology, Inc. is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. The Company's THIO (6-thio-dG, 6-thio-2'-deoxyguanosine), is a lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. 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 tumor regression in advanced, in vivo cancer models by induction of cancer type-specific immune memory. 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 the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
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- FDA Fast Track Designation: In July 2025, Ateganosine received FDA Fast Track designation, recognizing its potential as a treatment for NSCLC, which is expected to expedite its market entry process.
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- FDA Fast Track Designation: The company secured FDA Fast Track designation for ateganosine, which will expedite its clinical trial process for non-small cell lung cancer, with potential commercial approval expected within 18 to 24 months, significantly enhancing its market competitiveness.
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- MAIA Purchase: Director Ngar Yee Louie bought 81,699 shares of MAIA at $1.22 each, totaling $100,000, and despite a 0.7% drop in stock price on the day, Louie's investment is currently up 22.4%, reflecting optimistic market sentiment towards the company's prospects.
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See More
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- Regulatory Acceleration: In 2025, the FDA approved over 50 oncology drugs, with a notable shift towards targeted therapies for high-unmet-need solid tumors in 2026, projecting a market opportunity of $326.82 billion by 2031, indicating robust commercial potential.
- Fast Track Designation: Oncolytics Biotech's pelareorep received FDA Fast Track Designation for KRAS-mutant colorectal cancer, showing a 33% response rate when combined with standard chemotherapy, significantly higher than the 10% with chemotherapy alone, which will expedite its approval process.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study comparing pelareorep with standard care in March 2026, with interim data expected by year-end, providing crucial clinical evidence in a competitive market.
- Team Expansion: Oncolytics Biotech recently appointed two key executives to enhance its strategic and operational capabilities, supporting its expanding R&D projects, reflecting the company's confidence and preparedness for future growth.
See More
Oncolytics Biotech Strengthens Leadership to Advance Clinical Programs
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.
See More
MAIA Biotechnology 2025 Highlights: Ateganosine Clinical Progress and Funding Support
- Clinical Trial Progress: As of May 15, 2025, Ateganosine demonstrated a median overall survival of 17.8 months in the THIO-101 trial for NSCLC, indicating its potential efficacy in heavily pre-treated patients and offering a new treatment option.
- FDA Fast Track Designation: In July 2025, Ateganosine received FDA Fast Track designation, recognizing its potential as a treatment for NSCLC, which is expected to expedite its market entry process.
- Funding Support: In September 2025, MAIA secured a $2.3 million grant from the NIH to expand the Phase 2 trial of THIO-101, while raising $17.6 million in capital throughout 2025, enhancing its research capabilities and financial stability.
- Strategic Collaboration Agreement: In June 2025, MAIA entered into a master agreement with Roche to conduct combination trials of Ateganosine with other drugs, further expanding its application potential in multiple hard-to-treat cancers.
See More
MAIA Biotechnology Secures FDA Fast Track for Ateganosine, Targeting Early Approval in 18 Months
- Clinical Trial Success: In 2025, MAIA achieved exceptional clinical data for ateganosine combined with checkpoint inhibitors, with disease control and survival rates significantly exceeding standard care benchmarks, indicating strong potential for early commercialization in non-small cell lung cancer treatment.
- FDA Fast Track Designation: The company secured FDA Fast Track designation for ateganosine, which will expedite its clinical trial process for non-small cell lung cancer, with potential commercial approval expected within 18 to 24 months, significantly enhancing its market competitiveness.
- Funding Support and Expansion: MAIA received a $2.3 million grant from the NIH to expand its Phase 2 trial, increasing patient recruitment and further validating ateganosine's efficacy, thereby enhancing its commercial relevance in the global immunotherapy market.
- Strategic Partnerships and Investment: Collaborations established with Roche and BeOne Medicines will support multiple combination trials for ateganosine, while the company raised approximately $17.6 million in capital throughout 2025, reflecting the board's confidence in the long-term value creation potential of the ateganosine platform.
See More
Amylyx and MAIA Executives Increase Stock Holdings Amid Market Fluctuations
- Amylyx Purchase: Karen Firestone acquired 8,100 shares of AMLX at $12.45 each for a total investment of $100,845, marking her first purchase in the past year, which indicates confidence in the company's future despite a 1.7% decline in stock price on the day.
- MAIA Purchase: Director Ngar Yee Louie bought 81,699 shares of MAIA at $1.22 each, totaling $100,000, and despite a 0.7% drop in stock price on the day, Louie's investment is currently up 22.4%, reflecting optimistic market sentiment towards the company's prospects.
- Market Reaction: Although both Amylyx and MAIA experienced stock price declines on Friday, the executives' purchases may enhance investor confidence and potentially lead to a price rebound, especially amid market fluctuations.
- Investor Confidence: Insider buying is generally viewed as a positive signal for future company performance, which could attract more investor interest and help alleviate concerns over short-term volatility in the market.
See More
MAIA Biotechnology Directors Purchase 179,737 Shares, Raising $1.51 Million
- Director Confidence: Independent directors of MAIA Biotechnology purchased a total of 179,737 shares and warrants at an average price of $1.224, reflecting strong confidence in the commercial potential of ateganosine, the company's first-in-class anticancer treatment.
- Successful Financing: The private placement raised approximately $1.51 million, with directors and officers now holding 5,019,857 shares, representing 13.43% of the company, providing essential funding for upcoming clinical trials.
- Trial Initiation: MAIA launched its pivotal Phase 3 international trial this month, with the first patient dosed, marking a significant milestone in value creation within the oncology sector.
- FDA Fast Track Designation: The FDA has granted Fast Track designation for ateganosine in treating non-small cell lung cancer, with statistical assessments indicating a very high probability of success for regulatory approval, further bolstering investor confidence in the company's future prospects.
See More
