On November 18, 2024 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 its ongoing Phase 1 trial of TGN-S11, its small molecule drug candidate, in patients with HPV-associated cancers (Press release, Toragen, NOV 18, 2024, View Source [SID1234648490]).

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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: Part 1 is escalating doses of TGN-S11 monotherapy and Part 2 is TGN-S11 in combination with Keytruda, a PD-1 checkpoint inhibitor. The dose escalation part consists of up to five Cohorts of three to six patients on monotherapy with increasing doses of TGN-S11. The Keytruda combination part consists of up to five Levels of three to six patients with increasing doses of TGN-S11 and the standard dose of Keytruda.

In Part 1, 9 patients were treated with TGN-S11 as monotherapy in the first 3 dose cohorts with no safety issues identified. One-third of the patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA (ctHPV DNA). In addition, three patients have been treated in Part 2 Level 1 evaluating TGN-S11 in combination with Keytruda with no safety issues. Two of these 3 patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA. One of these 3 patients continues to receive combination therapy and has a 93% reduction in ctHPV DNA. The study is ongoing with patients currently being dosed in Part 1 Cohort 4 and Part 2 Level 2.

"We have been very pleased with the positive safety profile for TGN-S11 in patients who completed the first 3 monotherapy dose cohorts of Part 1 and the first level of Part 2 in combination with Keytruda in this ongoing Phase 1 trial," said Dr. Sandra Coufal, Toragen’s CEO. "The drug activity observed in 5 of these 12 subjects is also very encouraging. Based on the current progress, we believe both parts of the study will be completed by the end of 2024."