Project description
New immuno-therapy aims at preventing metastasis in Prostate Cancer
Prostate cancer is the commonest cancer in males, with millions of new cases every year and a high mortality rate. There is an urgent need for effective prevention of metastases after treatment of localised cancer, as more than 40% of these patients currently progress to the metastatic stage. The EU-funded RV001 project from the Scandinavian biotech company, RhoVac, is focused on the development of a therapy aiming to prevent or postpone patient progress into metastatic stage disease. In a Phase I/II clinical trial, RhoVac demonstrated the safety and biological activity of their drug candidate. Within this project, RhoVac's goal is to demonstrate the efficacy of its therapy in a large multi-centre Phase IIb clinical trial, recruiting more than 175 patients, and then to out-license the drug to a large pharmaceutical company. Uniquely, this immuno-therapy approach is specific to metastatic cancer cells, but it is not specific to any particular type of cancer, and as such it is expected that RV001 could also be developed for other types of metastasising cancer.
Objective
Prostate cancer is the most commonly diagnosed cancer in men, with 1.7M new cases and 0.5M deaths anticipated by 2030 worldwide. Although metastases are responsible in 90% of cancer deaths, in today’s standard treatment there is no active therapy after removal of primary tumor to prevent metastasis formation. 40% of patients experience relapse of cancer in the first 2 years after surgery. The existing treatments focusing on later stages, do not prevent the initial spread of metastatic cells and cause numerous undesirable side effects. Late stage immunotherapies against metastatic cancer also present major drawbacks, including high costs and adverse events. So, there is a critical unmet need for a therapy that can effectively prevent metastasis formation in early stage prostate cancer.
RhoVac aims to address this need by developing the first therapeutic vaccine against early stage metastases in prostate cancer – RV001 – which could revolutionize the treatment of metastatic cancer. Through the activation of the patient’s own immune system, RhoVac projects that RV001 will induce the specific elimination of metastatic cancer cells with unprecedented levels of safety, tolerability and biological activity, proven with the successful conclusion of a Phase I/II clinical trial in 2018. RhoVac aims to develop the RV001 vaccine up to completion of a Phase IIb clinical trial (key objective of the present project), following which the company plans to out-license the vaccine to a large Pharma, with conservatively predicted revenues of ca. €1B, within 5 years of vaccine launch.
Due to its mechanism, RV001 could potentially be used against all metastatic cancer types. RhoVac will seek to validate this exploratively in parallel with the prostate cancer project. In short, our aim to introduce “metastatic prevention” as new paradigm in cancer treatment, rather than relying on the frequently ineffective treatment of metastases that have already formed.
Fields of science
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
2970 Horsholm
Denmark
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.