Our team is comprised of industry leaders with decades of experience in early-stage biotechnology companies, translational drug development, and pivotal clinical trials.
Toragen is focused on developing novel cancer treatments to treat viral-associated cancers and significant infections.
Toragen has initiated a Phase I clinical trial with its lead compound in HPV-induced cancer.
Toragen, Inc. is a clinical-stage oncology company focusing on the treatment of Human Papillomavirus (HPV) induced cancers, which cause 5% of all cancers worldwide.
Head and neck cancer (OPSCC) is a significant worldwide health issue with high mortality and morbidity. Despite an approved vaccine against HPV, incidences of HPV-induced cancers continue to rise and are expected to nearly double by 2040.
About 70,000 new cases of OPSCC are predicted to occur each year, resulting in 34,000 deaths.
Despite advances in therapy over the past decade, there remains significant morbidity and mortality from this disease. There is clearly an urgent need to develop effective new treatment options for patients with OPSCC.
Toragen has identified a lead small molecule compound (TGN-S11) with a clear mechanism of action which is the inhibition of E5 oncogene protein.
Toragen received an IND proceed letter in February 2023 and is entering a Phase 1 trial in 1H 2023.
- TGN-S11 is an approved antimicrobial, which allowed quick Phase 1 startup
- TGN-S15 is a second generation compound that has demonstrated increased efficacy and decreased side effects in preclinical testing, suggesting the potential for chronic dosing at higher dose levels compared to TGN-S11
Checkpoint Blockade Immunotherapy is revolutionizing oncology, with an estimated $30B market by 2025. Anti-PD-1/PD-L1 immunotherapy is now FDA approved to treat patients with recurrent or metastatic OPSCC with disease progression on or after platinum-containing chemotherapy. However, objective response rates to anti-PD-1 immunotherapy are low, ranging below 25%. Thus there is a critical need to develop combination therapies to improve response rates and understand mechanisms of resistance.
TGN-S11 was initially developed and FDA-approved as an anti-microbial drug. Anti-tumor activity of TGN-S11 has not been previously reported. We have discovered that TGN-S11 decreases the growth of HPV+ tumor cells and improves survival in mice with HPV+ tumors.
Toragen has begun a Phase I Clinical trial of the single agent TGN-S11 in up to 30 patients with HPV- associated malignancies. This will be a dose escalation study with the primary endpoints being maximum tolerated dose, safety, and identifying toxicities.
An expansion phase will begin in an additional 25 patients who will receive anti-PD-1 immunotherapy in combination with TGN-S11.