Market Opportunity in Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) is a significant worldwide health issue with high mortality and morbidity. Every year more than 640,000 new cases of HNSCC are diagnosed worldwide, ranking 5th in incidence. Main risk factors include tobacco and alcohol use, and human papillomavirus (HPV) infection. More than 330,000 people die annually.
In the United States, more than 61,000 new cases of HNSCC are predicted to occur each year, resulting in 13,000 deaths while the incidence is rising dramatically mostly related to a rise in HPV-related oropharyngeal cancer.
Despite advances in therapy over the decade, there remains significant morbidity and mortality from this disease and there is clearly an urgent need to develop effective new treatment options for patients with HNSCC.
Human Papillomavirus (HPV 16)
Approximately 42,700 HPV-associated cancers occur in the United States each year1. HPV causes multiple different types of cancers including head and neck, cervical, and genitourinary cancers. There is a critical need for additional therapies to treat HPV associated cancers beyond just head and neck cancers. Toragen is developing compounds targeting HPV oncogenes to enhance immune responses.
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 cisplatin refractory metastatic head and neck cancer. However, objective response rates to anti-PD-1 immunotherapy are low, ranging from 18-26%. Thus there is a critical need to develop combinatorial strategies to improve response rates and understand mechanisms of resistance.
Toragen Lead Compound – TGN-S11
TGN-S11 was initially developed and approved as anti-microbial drug. However, anti-tumor activity of TGN-S11 has not been previously reported. We have discovered that it decreases the growth of HPV+ tumor cells and improves survival in mice with HPV+ tumors.
The lead compound is an FDA approved drug which was found to have novel anti-tumor activity. It is currently FDA approved for a non-cancer indication. This drug has robust anti-tumor activity in multiple Head and Neck Cancer tumor models.
Toragen Phase I Clinical Trial
Toragen is ready to begin a Phase I Clinical trial of single agent TGN-S11 in 12-15 patients with HPV associated malignancies. This will be a dose escalation study with the primary endpoint being feasibility, safety, and toxicity. We will monitor for clinical activity of TGN-S11 as a single agent. An expansion phase will follow to test TGN-S11 in an additional 15 patients who are receiving anti-PD-1 immunotherapy.
Toragen Research and Developmental Compounds
Toragen is developing additional drugs and screening new viral modifying analogs.
- Screening Assays
- Liposome Permeability Assay
- Amenable to HTS
- Proton Flux Assay
- TEVC Oocyte Assay
- Liposome Permeability Assay
- Other known inhibitors
- In-Silico Screening
- Library Screening
1 Centers for Disease Control and Prevention, July 8, 2016