HPV+ Head and Neck Cancer
HB-201 and HB-202 are TheraT® applications for the treatment of Human Papillomavirus (HPV)-associated head and neck cancers. These therapies are designed with a viral backbone consisting of LCMV - and LCMV and Pichinde - respectively. Together they target the fusion protein E7E6.
Squamous cell carcinoma of the head and neck is now the eighth most common cancer affecting men in the United States largely due to a rising epidemic of oropharyngeal (tonsil and tongue base) cancer associated with HPV. The median overall survival (OS) for advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck (SCCHN) remains less than one year despite modern chemotherapy and targeted agents. Although cancers of the head and neck are often caused by tobacco and alcohol, recent studies show that about 70% of cancers of the oropharynx may be linked to HPV. Additionally, the majority of cervical and anal cancers are similarly known to be caused by HPV. Our TheraT® technology is specifically engineered to target these types of viral based cancers.
In 2018 in the US alone there were 164,000 men diagnosed with prostate cancer. An estimated 1.1 million men worldwide were diagnosed with prostate cancer in 2012, accounting for 15% of all cancers diagnosed in men, with almost 70% of the cases (759,000) occurring in more developed regions. With an estimated 307,000 deaths in 2012, prostate cancer is the fifth leading cause of death from cancer in men (6.6% of the total men deaths). In 2018 in the US alone there were 164,000 men diagnosed with prostate cancer with 30,000 deaths, representing an annual mortality rate close to 10%. Despite significant progress in the treatment of prostate cancer, mainly through the targeting of the androgen pathway, significant work remains. CD8 T cell targeted therapy for prostate cancer, via Dendreon’s Provenge vaccine continues to show a survival advantage, but its use is limited by its nature as a personalized ex vivo dendritic cell therapy. Our approach, as outlined above, is in essence an in vivo ‘off the shelf ‘dendritic cell therapy approach, and one that is predicted to elicit the kinds of antigen specific CD8 T cell levels previously seen only with ex vivo approaches. Furthermore, by targeting three prostate cancer antigens (PSA, PAP, and PSMA) we anticipate to have significant efficacy.
Our first clinical programs in oncology utilize TheraT® encoding tumor antigens that have shown to be (at least partially) effective where sufficient amounts of antigen specific CD8 T cells could be generated. We believe that after demonstrating TheraT®’s ability to generate superior levels of CD8 T Cells against these validated antigens, the lack of availability of more validated antigens in other cancer indications will be a limitation for leveraging TheraT® broadly to fully exploit its potential in the field of oncology. Since the scarcity of antigens is a problem for the field as a whole, we have decided to incorporate a novel approach to identify the next generation of shared antigens into our corporate strategy. Specifically our goal is to discover novel shared immunogenic, tumor-specific full length antigens. We envision that this next generation of shared antigens will support and complement our significant efforts driven by our current proprietary platform by adding additional disease targets to our product pipeline.