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.
Clinical Trials
7
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2018
Active, not recruiting
4
57.1%
Recruiting
3
42.9%
No approval data available
- MAIA Biotechnology reported that its pivotal Phase 3 THIO-104 trial of ateganosine in third-line advanced NSCLC has reached 65 randomized patients across 38 activated sites in six countries. - The company said it remains on track to exceed 100 randomized patients by year-end, with additional clinical sites expected to begin enrolling. - Ateganosine sequenced with a checkpoint inhibitor showed a 90.5% interim disease control rate in heavily pretreated third-line NSCLC in the Phase 2 THIO-101 trial, versus 25% to 35% for standard third-line chemotherapy. - The FDA granted ateganosine Fast Track designation for NSCLC in July 2025, and approval would carry five-year New Chemical Entity marketing exclusivity.
- MAIA Biotechnology has dosed the first U.S. patient in the Phase 2 THIO-101 expansion testing ateganosine in third-line non-small cell lung cancer. - The U.S. expansion is funded by a $2.3 million NIH grant and follows FDA clearance of MAIA's amended IND submission citing improved manufacturing capabilities. - Ateganosine holds FDA Fast Track designation, and prior THIO-101 Parts A and B data showed overall survival beyond 24 months in eight patients. - The trial pairs low-dose ateganosine with cemiplimab (Libtayo) in patients resistant to prior checkpoint inhibitor and chemotherapy treatment.
- MAIA Biotechnology presented oral and poster data on its next-generation telomere-targeting cancer therapies at the XXVI International Round Table on Nucleosides, Nucleotides and Nucleic Acids in Barcelona. - The divalent candidates combine lead agent ateganosine with a complementary DNA-targeting agent in a single prodrug molecule to attack tumors through multiple mechanisms. - Next-generation agents showed increased anticancer activity in preclinical in vitro and in vivo models, with structural features linked to stronger antitumor activity identified. - Ateganosine is in clinical development for non-small cell lung cancer as a second- or later-line treatment for telomerase-positive tumors progressing after checkpoint inhibitors.
- MAIA Biotechnology is a clinical-stage biopharmaceutical company developing a proprietary platform for site-specific conjugation of monoclonal antibodies with diagnostic and therapeutic radioisotopes. - Director Ramiro Guerrero acquired 11,899 shares at $1.37 per share, increasing his position by 2.02% to 600,117 shares, reflecting positive insider sentiment. - Noble Financial analyst Robert LeBoyer reiterated a Buy rating with a $14.00 price target, while the Street consensus stands at a Moderate Buy. - The company's approach aims to deliver high-contrast tumor visualization via PET imaging and focused cytotoxicity in oncology indications.
- MAIA Biotechnology is developing ateganosine, a potential first-in-class telomere-targeting agent designed to exploit telomerase activity present in more than 80% of human tumors. - The FDA has granted Fast Track Designation for ateganosine in NSCLC patients resistant to immunotherapy and chemotherapy, with a Phase 3 THIO-104 trial now initiating. - The drug targets a significant unmet medical need in the $34.1 billion NSCLC market, addressing patients without actionable mutations who no longer respond to checkpoint inhibitors. - Ateganosine has received FDA Orphan Drug Designations for glioblastoma, hepatocellular carcinoma, and small cell lung cancer, providing seven years of market exclusivity upon approval.
- Maia Biotechnology's telomerase modifier ateganosine demonstrated a median progression-free survival of 5.6 months compared to 2.5 months with standard of care in third-line NSCLC patients. - The sequential combination of ateganosine followed by cemiplimab achieved a disease control rate of 77% versus 25-35% with chemotherapy in heavily pretreated patients. - Median overall survival reached 17.8 months, approximately 5.8 months longer than the highest OS data reported in recent real-world analyses. - Safety concerns emerged at the highest dose level with one patient experiencing Grade 4 liver function test elevation, leading to treatment pause in the 360mg arm.
- MAIA Biotechnology appointed two prominent hepatocellular carcinoma specialists, Dr. Claudia Fulgenzi and Dr. David J. Pinato, to its Scientific Advisory Board to guide upcoming clinical trials. - The company expects to receive all required approvals to begin enrolling patients in a hepatocellular carcinoma trial by the end of 2025. - MAIA's lead candidate ateganosine received FDA Orphan Drug Designation for HCC treatment in 2022, providing potential seven-year market exclusivity. - Hepatocellular carcinoma represents approximately 90% of all liver cancers and ranks 5th by incidence and 3rd by mortality globally.
- The combination of THIO (ateganosine) plus cemiplimab showed clinical activity with a 77% disease control rate in patients with advanced NSCLC resistant to immune checkpoint inhibitors. - Median overall survival reached 17.8 months in the third-line setting, with partial responses observed in 10 patients across second- and third-line treatments. - The treatment was generally well tolerated with most adverse events being grades 1-2, and biomarker analyses suggested response occurred independent of PD-L1 status. - Elevated interleukin-6 levels may serve as a predictive biomarker for treatment efficacy, with the 180 mg THIO dose showing optimal safety and efficacy profile.
- MAIA Biotechnology completed a $695,000 private placement offering 463,332 shares and warrants to fund its Phase II THIO-101 cancer trial. - The company will use proceeds to cover starting costs for Step 1 of Part C of the Phase II trial and working capital needs. - Investors received shares at $1.50 each with five-year warrants exercisable at $1.71, including participation from company director Stan Smith. - The securities were issued as restricted securities without registration rights, with closing expected on May 29, 2025.
- 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.
