On December 1, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported that it has submitted clinical study protocol to the US FDA for the initiation of a Phase 2 Trial (designated "M201") for OT-101, the Company’s TGF-β inhibitor, in combination with Anti-PD-1 (Pembrolizumab/Keytruda) as a treatment for patients with Malignant Pleural Mesothelioma (MPM) (Press release, Oncotelic, DEC 1, 2021, View Source [SID1234596348]).
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M201: Phase 2 Trial of TGF-β Inhibition (OT-101) with Anti-PD-1 (Pembrolizumab) in Patients with Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition.
OT-101 is a first-in-class anti-TGF-β ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19 patients. Both tumor cells and SARS-Cov-2 induce TGF-β as part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is expected to impact both cancer and COVID.
The OT-101 oncology program ("OT-101-ONC") is designed to assess the impact of OT-101 across multiple cancer indications where local tumoral secretion of TGF-β suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliance with top pharmaceutical companies. Of note is the biomarker program spanning mesothelioma, glioblastoma, lung and colorectal cancers, where AI driven transcriptome analyses will be used to derive the predictive biomarker for TGF-β therapeutics such as OT-101.
"This is the first of a series of planned clinical trials in patients with various solid tumors evaluating clinical benefit while also assessing a host of parameters associated with changes in the tumor microenvironment, including but not limited to T-cell infiltration, expression of various cytokines, and phenotypic and functionality changes pre-therapy versus post-therapy." noted Dr. Anthony Maida, Chief Clinical Office – Translational Medicine.
"The groundwork laid down by OT-101/IL-2 and OT-101/PD-1 will serve as the foundation for future strategic alliances for OT-101/CAR-T and OT-101/Vaccines." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. "CAR T-cell therapy, in which a patient’s immune T cells are modified so they will bind to cancer cells and kill them, has been shown to benefitted greatly from TGF-β inhibition in early clinical testing."