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Press Release

First patient in treatment in RhoVac's clinical phase IIb study in the USA

Aug 10, 2020

RhoVac AB ("RhoVac") announces today, August 10th 2020, that the first patient in the USA is included in the company's clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac").

The first patient in the USA is included in RhoVac’s clinical phase IIb study, called BRaVac. The first US clinic to include a patient in the study was Carolina Urologic Research Center. BraVac 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. BRaVac is an international, multi-centre study, which will recruit over 175 patients in six European countries (Denmark, Finland, Germany, Belgium, Sweden, and the UK) plus the USA. The study has already commenced in Denmark, Finland, Germany, Belgium and now in the USA. RhoVac anticipates recruitment to start very soon also in Sweden and the UK, and the company expects the phase IIb recruitment to be complete by end 2020, and the trial to conclude end 2021.

Anders Månsson, CEO, comments: “We have truly reached a great milestone in now recruiting patients also in the USA, which is the largest and most important market in the world for our drug candidate RV001. I am very happy and proud that we have been able to keep our important clinical phase IIb trial going, and that more and more countries are joining the study, despite the impact of the pandemic.”

About 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. Therefore, RhoVac is launching 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 tumor. 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