On December 12, 2023 Toragen Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported positive safety data from Cohort 2 of its Phase 1 trial of TGN-S11, its first drug candidate, in patients with HPV-associated cancers (Press release, Toragen, DEC 12, 2023, View Source [SID1234638519]).

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This Phase 1 trial is an open-label, non-randomized study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The study is being conducted in two parts: a dose escalation part and dose expansion part. The dose escalation consists of five Cohorts of three to six patients. The dose expansion will now begin in parallel with Cohort 3 of the dose escalation. Level 1 of the dose expansion part of the Phase 1 trial will be in combination with a PD-1 checkpoint inhibitor.

"Having this early safety signal for our dose escalation portion of our Phase 1 trial is yet another early milestone for Toragen," said Dr. Sandra Coufal, Toragen’s CEO. "By beginning the dose expansion portion of the Phase 1 trial in an accelerated timeframe, we bring hope of meeting an unmet medical need for HPV-cancer patients by possibly enhancing the efficacy of the PD-1 checkpoint inhibitor."