MAIA Biotechnology, Inc. Announces $6.2 Million Financing to Advance Targeted Immuno-Oncology Studies

On October 14, 2021 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 $6.2 million in an equity offering at $8/share (Press release, MAIA Biotechnology, OCT 14, 2021, View Source [SID1234591249]). The proceeds of the financing will advance the company’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). The THIO-101 trial is expected to begin this year.

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"We are excited to have closed this latest financing round, which brings MAIA additional capital as we continue to advance our THIO program," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We appreciate the continued support of our high-quality investors who share our vision developing novel cancer therapies aimed at overcoming treatment resistant diseases."

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 immune system activation by administering THIO in advance of administration of the checkpoint inhibitor (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, 6-thio-2’-deoxyguanosine) is a potentially first-in-class small molecule that, to our knowledge, is the only cancer telomere targeting agent currently in development. THIO is believed to selectively target telomerase-positive cancer cells, which account for more than 85% of human cancers. Data from pre-clinical studies showed that THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. Studies to date also showed that telomerase recognizes THIO and selectively incorporates it into the telomeres in tumor cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends, which results in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in pre-clinical models and produced cancer cell-specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results support the hypothesis that demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, and provides a strong rationale for sequentially combining telomere-targeted therapy with immunotherapy. THIO is investigational and has not been approved yet for any use by regulatory authorities.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. It is estimated that, in 2020, more than 2.2 million new cases were diagnosed globally, including 228,000 new cases in the U.S. Approximately 85% of all lung cancers are NSCLC and an estimated 80% of these cases are telomerase positive. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains a significant unmet need to optimize treatment of patients and offer additional clinical options.