On March 16, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that it has raised an additional $2.4 million in an equity offering of its common stock (Press release, MAIA Biotechnology, MAR 16, 2022, View Source [SID1234610185]). The proceeds of the financing will advance MAIA’s programs and will support the initiation of a Phase 2 clinical trial (THIO-101) evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC).
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"This latest funding round advances our clinical development plans for THIO and gives us additional runway to execute on our plans," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Our cash position stands at over $11 million and there is no long-term debt on our balance sheet. Our investor support remains very strong and we are thrilled to work together with investors who are committed to developing novel oncology therapies to improve patients’ lives."
About the Phase 2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)
This trial (THIO-101) will be the first to test THIO’s potential anticancer effects and immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.
The THIO-101 trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 41 evaluable patients.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. 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.