On June 30, 2023 Toragen, Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported that it has initiated a Phase 1 clinical trial to evaluate its first drug candidate (TGN-S11) (Press release, Toragen, JUN 30, 2023, View Source [SID1234633017]). It is believed that HPV survives within the cells and can eventually cause cancer by blocking immune responses and going undetected by the immune system. Toragen’s drug candidate, TGN-S11, inhibits the E5 oncogene of HPV in pre-clinical studies. Toragen believes this will allow the HPV-infected cancer cells to be detected by killer T-cells which could trigger an immune response that could be beneficial in cancer treatment.
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This Phase 1 trial is an open-label, non-randomized, dose escalation/dose expansion trial in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The expansion phase will begin in parallel, one dose level lower than the highest dose deemed safe in the dose escalation phase in combination with a PD-1 checkpoint inhibitor. The trial is anticipated to enroll up to 55 patients at approximately six sites in the United States.
"We are excited to announce the enrollment of our first patient in our first clinical trial with TGN-S11. Not only were we able to rapidly achieve our goal of beginning this clinical trial, but we are thrilled to transition Toragen to a clinical-stage company," said Dr. Sandra Coufal, Toragen’s CEO. "This is a historic milestone for the company and moves forward our mission to improve outcomes for patients with HPV-induced cancers."