On November 15, 2022 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA," "the Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the results of a pre-clinical study of the Company’s lead drug candidate, THIO, in hepatocellular carcinoma (HCC) in vitro and in vivo models. MAIA presented the data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held Nov. 8-12 virtually and in Boston (Press release, MAIA Biotechnology, NOV 15, 2022, View Source [SID1234624114]).
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The results indicate that THIO, a first-in-class telomere-targeted agent may enhance the overall therapeutic efficacy of current immune checkpoint inhibitor-based treatments for HCC. In April, MAIA received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for THIO for the treatment of HCC.
Before the study, the researchers hypothesized that telomere-targeting agents may be effective in HCC. The study evaluated the activity of THIO and second-generation analogues in vitro using telomerase-positive HCC cells and in vivo using syngeneic mouse models of aggressive HCC.
The study found that THIO treatment:
Directly killed cancer cells, as it induced replicative stress, followed by cell cycle arrest and apoptosis in telomerase-reactivated HCC cells.
Stimulated anti-tumor immune response, as it activated pathways associated with innate and adaptive immunity and altered the immune-suppressive tumor microenvironment in syngeneic mouse models of aggressive HCC.
Enhanced the response to immune therapy checkpoint inhibitors, yielding complete responses in some HCC model systems with no dose-limiting toxicities.
"In addition to observing complete responses with no recurrence after THIO treatment, we identified immune memory, meaning that the body was able to autonomously target cancer cells when challenged with an influx of even more cancer cells," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are thrilled with this latest set of data as all models treated with THIO exhibited curative properties. The projected growth of liver cancer cases illustrates an increasing unmet global medical need for effective HCC therapies and this latest data reaffirms our belief in THIO’s potential to address it. We also strongly believe that the U.S. FDA’s Orphan Drug Designation of THIO for HCC further validates the quality of our data, and we look forward to continuing its clinical development."
About the SITC (Free SITC Whitepaper) 37th Annual Meeting
The SITC (Free SITC Whitepaper) 37th Annual Meeting provides a multidisciplinary educational and interactive environment focused on improving the outcome for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy. The Annual Meeting consists of cutting-edge research presentations by experts in the field, oral and poster abstract presentations and ample opportunity for structured and informal discussions, including important networking opportunities. In addition, the meeting includes updates on major national and international initiatives coming from academia, government and industry, as well as important society projects. Additional meeting information is available on SITC (Free SITC Whitepaper)’s website.
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 non-small cell lung cancer (NSCLC), in sequential administration with cemiplimab (Libtayo), a PD-1 inhibitor developed by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.