On May 19, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing first-in-class oncology drugs, reported that it has raised $8.0 million financing in a convertible note offering led by new investor Checkmate Capital Group with participation from other strategic and existing investors (Press release, MAIA Biotechnology, MAY 19, 2021, View Source [SID1234580297]). The proceeds of the financing will advance the company’s targeted immuno-oncology programs and will support the initiation of a Phase 1/2 clinical trial evaluating THIO followed by Libtayo (cemiplimab) in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The Phase 1/2 clinical trial is expected to begin later this year.
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"We are excited to expand MAIA’s investor base and welcome several new investors who have extensive expertise in immuno-oncology and biotechnology investing. This funding round brings MAIA the necessary capital to accelerate development of the THIO program," stated Vlad Vitoc, MD, MAIA’s Chief Executive Officer and President. "We appreciate the investors’ recognition of THIO’s well-demonstrated clinical safety profile and promising efficacy potential in a variety of advanced tumors."
Lead investors in this financing included a diverse group of strategic investors, including Checkmate Capital Group, BRK Financial Group, and MDL Investments.
"As experienced investors in successful immuno-oncology companies, we have been deeply impressed with the THIO pre-clinical results in multiple difficult-to-treat tumor types. The data from sequential administration of THIO followed by Libtayo raise the prospect of a groundbreaking advancement in cancer treatment," commented Alex Monsef, Managing Director from Checkmate Capital Group. "We see the THIO program as having the potential to transform the immuno-oncology landscape. We are thrilled to invest in this exciting technology platform led by a world class oncology team at MAIA."
About the Phase 1/2 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 followed by administration of the checkpoint inhibitor Libtayo (co-developed by Regeneron and Sanofi), 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 did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.
The 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 40 evaluable patients.
About THIO
THIO (aka 6-thio-dG, 6-thio-2’-deoxyguanosine) is a first-in-class small molecule that is the only cancer telomere targeting agent currently in development. THIO selectively kills telomerase-positive cancer cells, which account for more than 85% of human cancers. THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. 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 demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, which 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.