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RV001: An anti-metastatic cancer vaccine

Periodic Reporting for period 1 - RV001 (RV001: An anti-metastatic cancer vaccine)

Reporting period: 2018-04-01 to 2018-09-30

Prostate cancer is the most commonly diagnosed cancer among men, with an anticipated 1.7M new cases and 0.5M deaths by 2030 worldwide. In today’s standard treatment, there is no active therapy after removal of primary tumor to prevent the development of metastatic cancer, while metastasis is responsible in 90% of cancer deaths. In this context, there is a high and unmet need for a therapy, which can effectively address the problem as the first adjuvant treatment against metastasis formation in prostate cancer.
RhoVac is developing the first therapeutic vaccine – RV001 – against initial formation and spread of metastatic cancer cells. The concept behind RV001 relies on the reprogramming of the patient own T cells to recognise and eliminate early stage metastatic cancer cells. Together with an unprecedented therapeutic potential in multiple cancer types, RV001 holds important competitive advantages, such as targeting a stage of the disease where there is currently no treatment available, high safety and cost-effectiveness.
Throughout the feasibility assessment in the SME instrument Phase 1, RhoVac aimed to i) do a market analysis, including definition of market; ii) engage with Key Opinion Leaders (KOLs) and strategic partners; iii) prepare the SME Instrument Phase 2 project; and iv) Develop a viable business plan.
As preparation for the innovation project, a feasibility study has been carried out during the last 6 months as an output of the SME Instrument Phase 1 project. We performed the following tasks: 1) Market assessment; 2) Pharma-economic assessment; 3) Setting up partnerships for Phase IIb clinical trials; 4) Stakeholder selection for Phase 2 Project; 5) Development of suitable business plan and business model; and 6) Plan Phase 2 innovation project.
RhoVac has successfully completed its phase I/II clinical trial. The company has met both its first and secondary endpoints showing the high safety profile of the drug and a significant immune response among a significant 86% of recruited patients. The company is now in preparation for the next phase of study, clinical phase IIb. If successful, in year 2025, RV001 vaccine will potentially target more than 150,000 patients in 5EU and US markets which can benefit from a treatment that limits advancing of their prostate cancer at early stage. Thus, RV001 is well positioned to become the standard of care for prevention of metastasis at early stage prostate cancer, with the potential to cover other cancer types.