Ahmed Al-Qahtani Ph.D.
KFSH&RC
Reid Rubsamen MD, MS, MHCM
CEO, Flow Pharma
Anthony Tufaro MD
Cleveland Clinic
Up to 70 percent of all organ transplant recipients are affected by squamous-cell or basal cell type skin carcinomas, with incidence increasing with the duration of immunosuppressive therapy. The etiology of these neoplasms has been traced to infection with human papilloma virus (HPV) types 8, 5, 16 and 15.
Flow Pharma has developed a microparticle T cell vaccine targeting the HPV E7 protein believed to drive malignant transformation in transplant associated skin cancers. Our central hypothesis is that targeting HPV type 5, 8, 15 and 16 E7 protein, HPV+ cells for cytotoxic CD8+ T cell attack following vaccination with the FlowVax-HPV cancer immunotherapy vaccine will provide meaningful protection against skin cancer associated with immunosuppression and transplantation.
The development and deployment of FlowVax HPV is likely to benefit the entire transplant population. Based on current data, we expect a high acceptance rate for FlowVax HPV, which targets HPV strains responsible for skin cancer not targeted by currently marketed HPV vaccines.
With about 46,000 solid organ transplants in the United States during 2023, a conservative 10% penetration at launch would result in 4,600 doses. At $300 USD per dose, this translates to $1.4M USD for the first year with expected year-over-year growth thereafter.
The FlowVax-HPV cancer immunotherapy has been developed through Technology Readiness Level (TRL) 6. The adjuvanted microsphere peptide vaccine platform has been tested in multiple animal models, with peer-reviewed journal articles describing the vaccine platform design and showing efficacy for protection against viral challenge.
Figure 1: FlowVax adjuvanted microspheres containing HLA class I and HLA class II peptide antigens are injected into a patient, taken up by antigen presenting cells, and through cross presentation, T-cell expansion occurs.
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