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Press Release

Mount Sinai Hospital in New York joins RhoVac’s Phase IIb Study in Prostate Cancer

Apr 21, 2021

RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today, April 21st 2021, that the prestigious Mount Sinai hospital in New York is initiated today as the latest addition to US trial centres in RhoVac’s clinical phase IIb study, “BRaVac”, in prostate cancer.   

Mount Sinai Hospital, founded in 1852, is one of the oldest and largest teaching hospitals in the United States, and it is widely recognised and one of the leading hospitals in the US, and indeed in the world, and as such RhoVac is extremely proud to declare its participation in the BRaVac trial.

The participation of Mount Sinai was directly caused by the FDA approval of RhoVac’s Fast Track Designation. Immediately after the news on the Fast Track Designation was made public, Mount Sinai contacted RhoVac via its Scientific Advisory Board member, Professor Per-Anders Abrahamsson, who brokered the connection to RhoVac management. It is an honour for RhoVac, and a recognition of the potential of its drug candidate, that such a world leading hospital spontaneously seeks to join its clinical trial.

The site initiation visit is held, today, April 21st , and the study will be supervised at Mount Sinai by Professor Ash Tewari. In the trial, RhoVac’s drug candidate, RV001, will be used in prostate cancer patients that have previously had a prostatectomy or definitive radiation therapy, but that now have suffered a “Biochemical Recurrence” (rising PSA) but who still have not developed detectable metastases. The objective of the development of RV001 is to prevent/delay the recurrence of cancer and its progression to a metastatic state. If a clinical proof of concept is obtained in prostate cancer, several other cancer indications would also be candidates for development.

RhoVac CEO, Anders Månsson, comments: “I was of course delighted when I learned that Mount Sinai wanted to join our study. I regard this as yet another example of the recognition that the Fast Track Designation has brought us already, and I am happy that we could get started so quickly. I wish Mount Sinai welcome on board the trial team, and I look forward to our collaboration”.   

On RhoVac AB

RhoVac was established as a private company in Denmark in 2007. Under this company, the basic development steps for the drug candidate RV001 were undertaken. In 2015 the Swedish RhoVac AB was formed, which is now headquartered and in 2016 the company was listed on the then Aktietorget in Sweden (now Spotlight Stock Market). RhoVac has passed the early stages of development. In 2018, the first clinical trial (phase I / II) was completed in prostate cancer, demonstrating that RV001 has good safety and is well tolerated, and that the drug provides the expected immune response that will exert its effect on the cancer cells. The strong immune response has also been shown to last over time. RhoVac has launched a clinical phase IIb trial that will include at least 175 prostate cancer patients. The study is designed to show, with statistical significance, the effect of RV001 in preventing disease progression in prostate cancer after surgery or radiation to the primary tumour. RhoVac is listed on Spotlight, Sweden, a Multilateral Trading Facility (MTF) since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com

On BRaVac

BRaVac is a clinical trial phase IIb-study is a randomized, placebo controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent treatment. The clinical phase IIb study is an international, multi-centre study, which will recruit over 175 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and United Kingdom) and the US.