MAIA Biotechnology Doses First U.S. Patient in Phase 2 THIO-101 Expansion of Telomere-Targeting Ateganosine in Third-Line NSCLC
核心洞察
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 (搜索).
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.
MAIA Biotechnology, Inc. (NYSE American: MAIA) announced that the first U.S. patient has been dosed in the Phase 2 THIO-101 trial expansion evaluating its telomere-targeting lead candidate, ateganosine, in third-line non-small cell lung cancer (搜索) (NSCLC). The milestone follows FDA clearance of the company's amended investigational new drug (IND) submission, which highlighted improved manufacturing capabilities and efficiencies.
The U.S. Phase 2 expansion is funded by a $2.3 million grant from the National Institutes of Health (NIH) to support third-line treatment evaluation, and MAIA has activated 3 sites in the United States.
"We have worked diligently to advance ateganosine into the U.S. market, and dosing the first patient in the United States represents a major milestone for our ongoing Phase 2 clinical trial," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "Our collaborations with some of the nation's top institutions and foremost oncologists further strengthen the trial as we evaluate ateganosine for patients in advanced stages of this exceedingly hard-to-treat disease. We believe the data generated through the THIO-101 program may also support a potential pathway toward FDA accelerated approval. With patients now enrolled across four continents, the study has evolved into a truly global effort focused on addressing a critical unmet need in cancer care."
Dual Mechanism and Prior Survival Signal
MAIA holds FDA Fast Track designation for ateganosine, described as a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. Prior data from THIO-101 Parts A and B show overall survival (OS) beyond 24 months in eight patients receiving ateganosine sequenced with a checkpoint inhibitor.
Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent in clinical development for NSCLC. Telomeres, along with the enzyme telomerase (搜索), play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2'-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activate both innate (cGAS/STING (搜索)) and adaptive (T-cell) immune responses. In advanced in vivo cancer models, sequential treatment of ateganosine followed by PD-(L)1 (搜索) inhibitors produced profound and persistent tumor regression through induction of cancer type-specific immune memory.
The agent is presently developed as a second or later line of treatment for NSCLC in patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
Trial Design and Endpoints
THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial and the first trial designed to evaluate ateganosine's anti-tumor activity when followed by PD-(L)1 (搜索) inhibition. The trial tests the hypothesis that low doses of ateganosine 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 a first-line treatment regimen containing another checkpoint inhibitor.
The trial design has two primary objectives: to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator, and to assess clinical efficacy using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion will assess ORR in advanced NSCLC patients receiving third-line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.
The trial is registered on ClinicalTrials.gov under the identifier NCT05208944.
Company Profile
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 intended to meaningfully improve and extend the lives of people with cancer. Its lead program, ateganosine, is a potential first-in-class cancer telomere-targeting agent in clinical development for NSCLC patients with telomerase (搜索)-positive cancer cells.