Oncotelic Therapeutics, Inc. announced the OT-101 oncology program (“OT-101-ONC”) is designed to assess the impact of OT-101 across multiple oncology indications, where local tumoral secretion of TGF-ß suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliances planned 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-ß therapeutics such as OT-101.

In June 2020, the Food and Drug Administration (the “FDA”) granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [=10 mutations/megabase (mut/Mb)] solid tumors, as determined by a FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.