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MAIA Biotechnology

MAIA Biotechnology logo
🇺🇸United States
Ownership
Public
Established
2018-01-01
Employees
13
Market Cap
$66.9M
Website
http://maiabiotech.com
Introduction

MAIA Biotechnology, Inc. is a clinical stage biotechnology company that is engaged in the discovery, development and commercialization of therapies targeting cancer. Its product, THIO, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. The company was founded on August 3, 2018 and is headquartered in Chicago, IL.

MAIA Biotechnology's Novel Cancer Drug Ateganosine Receives USAN Approval for NSCLC Treatment

• MAIA Biotechnology has secured USAN Council approval for "ateganosine" as the nonproprietary name for its lead anticancer agent THIO, marking a crucial regulatory milestone. • Ateganosine is a first-in-class telomere-targeting agent in clinical development for advanced non-small cell lung cancer, designed to induce selective cancer cell death and activate immune responses. • The drug works by altering telomeric guanosine in cancer cells and has shown promising results when used sequentially with PD-(L)1 inhibitors, demonstrating tumor regression in advanced cancer models.

Key Trials in Transplant-Ineligible NDMM

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MAIA Biotechnology's THIO Shows Promise in Phase II Lung Cancer Trial; Institutional Investment Increases

• MAIA Biotechnology's lead candidate, THIO, is currently in Phase II clinical trials, evaluating its potential in treating patients with non-small cell lung cancer. • Recent SEC filings reveal that Geode Capital Management LLC increased its stake in MAIA Biotechnology by 22.9% during the third quarter, indicating growing investor confidence. • Greenwich LifeSciences' GP2 immunotherapy is in Phase III clinical trials, aimed at preventing breast cancer recurrences in patients post-surgery. • Institutional investors and hedge funds have shown increased interest in Greenwich LifeSciences, with Geode Capital Management LLC raising its position by 4.6%.

MAIA Biotechnology Advances THIO to Phase 3 for Advanced NSCLC

• MAIA Biotechnology plans to initiate the THIO-104 Phase 3 trial in 2025 to assess THIO in non-small cell lung cancer (NSCLC) patients resistant to checkpoint inhibitors. • The THIO-104 trial will be a multicenter, open-label study comparing THIO sequenced with a checkpoint inhibitor to chemotherapy in a 1:1 randomization of up to 300 patients. • The primary endpoint of the THIO-104 trial is overall survival, with secondary endpoints including disease control rate, overall response rate, and progression-free survival. • THIO is a first-in-class investigational telomere-targeting agent, and MAIA aims for FDA commercial approval following the THIO-104 trial.

MAIA Biotechnology and BeiGene Collaborate to Evaluate THIO in Multiple Cancers

• MAIA Biotechnology and BeiGene enter a clinical supply agreement to assess THIO, combined with tislelizumab, in Phase 2 trials. • The trials will focus on hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC). • Preclinical results showed THIO, combined with CPI, induced potent anti-tumor immune responses and complete responses in various cancer models. • MAIA retains global development and commercial rights to THIO, targeting accelerated FDA approvals for multiple cancer indications.

MAIA Biotechnology Secures Funding to Advance THIO Clinical Trials

• MAIA Biotechnology has announced a private placement of common stock and warrants, expected to generate approximately $950,000 in gross proceeds. • The funding will support the manufacturing of THIO for Phase II clinical trials, advancing its development as a potential cancer therapy. • The private placement involves accredited investors and company directors, signaling internal confidence in MAIA's prospects and THIO's potential. • MAIA Biotechnology secured an additional $2.715 million via private placement to initiate Part C of the Phase II THIO-101 trial.

MAIA Biotechnology's THIO Shows Promising Survival Benefit in Advanced NSCLC

• MAIA Biotechnology's THIO, combined with cemiplimab, demonstrated a median overall survival of 16.9 months in advanced NSCLC patients who failed prior therapies. • The Phase 2 THIO-101 trial data suggests a significant improvement compared to standard-of-care chemotherapy, which typically shows overall survival of 5-6 months. • The trial's findings support MAIA's regulatory strategy, potentially paving the way for accelerated FDA approval of THIO for third-line NSCLC treatment. • THIO's dual mechanism targets telomeric DNA damage and boosts cancer-specific immune responses, offering a novel approach to treating resistant NSCLC.

MAIA Biotechnology and Regeneron Expand Clinical Trial Collaboration for NSCLC Treatment

• MAIA Biotechnology and Regeneron have expanded their clinical supply agreement to further evaluate THIO in third-line NSCLC patients. • The Phase 2 trial, THIO-101, will assess THIO sequenced with cemiplimab (Libtayo®) in patients resistant to prior checkpoint inhibitors and chemotherapy. • MAIA expects to begin enrolling new patients soon and is exploring potential accelerated approval opportunities based on trial outcomes. • Preliminary results from THIO-101 have demonstrated favorable disease control, progression-free survival, and overall response rates.
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