Toragen, a San Diego-based clinical-stage biotechnology company, has launched a Phase 1 clinical trial to evaluate its initial drug candidate, TGN-S11, targeting cancers instigated by viruses.

This advancement could potentially revolutionize the treatment of Human Papillomavirus (HPV) related cancers.

HPV is believed to dwell within cells, remaining unnoticed by the immune system, which can eventually lead to cancer by inhibiting immune responses. Toragen’s drug candidate, TGN-S11, in pre-clinical studies, has shown the potential to inhibit the E5 oncogene of HPV.

Toragen anticipates that this action will enable HPV-infected cancer cells to be recognized by killer T-cells, possibly initiating an immune response that could prove beneficial for cancer treatment.

This Phase 1 trial is a non-randomized, open-label dose escalation/dose expansion trial and will be conducted on cohorts of patients suffering from relapsed, resistant, or metastatic HPV-associated cancers.

The expansion phase of the trial will commence in parallel and at one dose level lower than the highest safe dose identified during the dose escalation phase. This will be in conjunction with a PD-1 checkpoint inhibitor.

The trial aims to enroll up to 55 patients across approximately six sites in the United States. This marks a significant milestone in Toragen’s quest to develop uniquely selective drugs targeting cancers triggered by viruses.

  California, HPV, TGN-S11, Toragen, USA