Toragen Inc, a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, announced positive safety data from Cohort 2 of its phase 1 trial of TGN-S11, its first drug candidate, in patients with HPV-associated cancers.
Toragen is primarily focused on uniquely selective drugs targeting cancers caused by the human papillomavirus (HPV). No safety issues identified in Cohort 2. Now the company is proceeding to Cohort 3, for which patients have been identified and it also proceeding to expansion phase for which patients are being recruited.
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.”
