On October 10, 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 fully enrolled patients in Cohort 1 of its Phase 1 clinical study to evaluate TGN-S11, its first drug candidate, in patients with HPV-associated cancers (Press release, Toragen, OCT 10, 2023, View Source [SID1234635835]).
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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 begin in parallel, if Cohorts 1 and 2 of the escalation part are observed to be safe and well-tolerated, and will be one dose level lower than the highest dose observed to be safe and well-tolerated in the dose escalation in combination with a PD-1 checkpoint inhibitor.
"We are delighted to have filled the first Cohort of our Phase 1 trial," said Dr. Neil Clendeninn, Toragen’s Chief Medical Officer. "Once the patients are treated for 28-days with TGN-S11, we intend to begin to enroll Cohort 2. Cohort 1 enrolled quickly, using just one clinical trial site, but we expect recruitment for Cohort 2 to be even more accelerated because we now have three clinical trial sites actively screening patients. Upon successfully completing Cohort 2, we will be able to move to the expansion phase in combination with a PD-1 checkpoint inhibitor."