Novel Drug Development
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
Anti-PD-1/PD-L1 Immunotherapy
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.
Our Pipeline
Toragen Lead Compound – TGN-S11
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 Phase I Clinical Trial
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.
TGN-S11 Directly Binds E5 Protein Reversing Inhibition of MHC to the Cell Surface
An open-label, non-randomized, Phase I, Dose Escalation/Dose Expansion study in cohorts of patients