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MAIA 資訊
MAIA 事件
MAIA Biotechnology Files $150M Mixed Securities Shelf
MAIA Biotechnology files $150M mixed securities shelf
MAIA Biotechnology Announces Initial Efficacy Data from THIO-101 Clinical Trial
MAIA Biotechnology announced initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line therapy for patients with advanced non-small cell lung cancer. Initial data from the THIO-101 Part C 3L studies1 show a disease control rate of 90.5% in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate. "The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment," said Vlad Vitoc, CEO "Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies." MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.
MAIA Biotechnology Activates Third U.S. Clinical Site for THIO-101 Trial
MAIA Biotechnology announced that the third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University, is activated and now enrolling patients. The trial studies MAIA's lead investigational telomere-targeting agent, ateganosine, as a third-line treatment for non-small cell lung cancer, NSCLC.
MAIA Biotechnology Receives FDA Approval to Expand THIO-101 Trial
MAIA Biotechnology announced that the U.S. Food and Drug Administration has cleared an amendment to update its investigational new drug application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer. Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials. MAIA obtained FDA clearance of its updated IND highlighting MAIA's improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.
MAIA Biotechnology Completes $33M Offering to Fund Lung Cancer Trial
MAIA Biotechnology announced that net proceeds from its $33M public offering of common stock in March are expected to fully fund the company's ongoing pivotal Phase 3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer. Ateganosine is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. The FDA has granted Fast Track designation for the drug in third line NSCLC treatment.
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