RV001: An anti-metastatic cancer vaccine

Cancer is the second leading cause of death globally, killing almost ten million across the world, and more than a million die each year in the EU alone. Prostate cancer is the commonest cancer in men: it accounts for just under a tenth of all cancers, and one in seven men will be diagnosed with prostate cancer in his lifetime. Two thirds of prostate cancer patients are diagnosed with the localised, pre-metastatic, stage of the disease, a stage in which the cancer is still curable. The problem is that it is impossible at this stage, when the curative intent surgery or radiation is performed, to know for sure if the cancer has already spread beyond the prostate or not. If this has happened removing the prostate surgically, or radiating the primary tumour, will not get rid of the cancer, and patients will die of their cancers, or with their cancers.

The metastatic prevention potential of RV001 could potentially change the standard of care in the global and European cancer immunotherapy market, yielding substantial health economic value gains.

RhoVac is developing the first prophylatic vaccine against metastastsis- RV001- which will revolutionize the treatment of all metastatic cancers. Through the activation of the patient's own immune sysem, RV001 induces the specific elimination of metastatic cancer with unprecedented levels of efficay and safety.

In August 2018, RhoVac reported positive top-line results on safety and on immune activation in their phase I/II clinical trial in prostate cancer patients.
In total, 22 prostate cancer patients received RV001 treatment over a period of approximately 30 weeks. The regimen was well tolerated and there was no treatment related grade 3, 4 or 5 reactions according to Common Terminology Criteria for Adverse Events (CTCAE). The primary end-point of the study was therefore achieved. No related allergic reactions to treatment and no treatment related Serious Adverse Events were reported. Local injection site reactions were noted; however, these reactions were all expected, and the study confirmed that the reactions are reversible. In conclusion, the study meets its endpoint.
21 of the 22 enrolled patients were eligible for immune response assessment based on IFNγ ELIspot analysis. The immune response was analysed and the results showed that 86% (18 of 21 of the eligible patients) show a significant immune response to RV001 in samples taken during or after treatment. To qualify as a Confirmed Immune Responder in RV001 protocol, patients are required to show a significant response in two of the three samples taken during or after treatment. This was the case for all 18 patients showing significant immune response. In conclusion, the results confirm that a vaccine mediated immune response is established following treatment with RV001 and the dose administered in the study is biologically active. The results from the follow up study shows that the RV001-induced immune respons is significantly strong 3, 6, 9 and 12 months after last treatment.

A randomized, double-blinded clinical phase IIb-study in prostate cancer patients has started, and results will be published late 2021.

Today’s prostate cancer standard treatment offers no active therapy after removal of primary tumour to prevent and limit the formation and spread of metastatic cells. The patients are typically under careful monitoring of
disease progression, mainly by measuring PSA level, and active surveillance. At a later stage, when cancer has already re-appeared, therapies such as ADT (sometimes in combination with radiotherapy) are used. A safe and effective treatment, preventing progression of disease, with essentially no undesirable side effects – such as RV001 drug candidate – would be of extreme importance for the extension of disease-free survival and quality of life in prostate cancer patients.

Periodic Reporting for period 3 - RV001 (RV001: An anti-metastatic cancer vaccine)

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