RhoVac Confirms Forecast – BRaVac Phase IIb study recruitment to close in Quarter 3 2021

RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today, May 31, 2021, that it confirms its previous forecast to be able to conclude recruitment for its multi-centre BRaVac Phase IIb study in Quarter 3 2021. Also, all new US clinics have been initiated to boost recruitment in the final months and further raise awareness in the USA.  

As was the case with many clinical trials, RhoVac phase IIb study in prostate cancer, BRaVac, suffered some delays during the course of Covid-19-pandemic in 2020 and 2021. The latest update was announced early March in connection with the Covid-19-vaccine roll-out and in connection with this RhoVac promised to get back with a more informed forecast for recruitment conclusion at a later stage. Now that this spring's patient recruitment has been completed and all new US clinics are operational, RhoVac confirms its forecast to complete the recruitment of the study during the third quarter of 2021. There are less than 50 patients left to recruit and the current recruitment pace points to a close in August; allowing for the impact of summer vacations in hospitals, RhoVac therefore forecasts recruitment closing in September. After closing, finalising the treatment of patients in the study is estimated to take 9-12 months.

RhoVac also announces that all new American sites have now been initiated so that the total number of clinics currently operating on the study in the USA is seven.  Apart from contributing to the recruitment this also raises awareness of RhoVac and its drug candidate in America, home to most of the company’s potential partner companies.    

RhoVac CEO, Anders Månsson, comments: “Keeping the phase IIb study going in the midst of the pandemic was quite a challenge, but we can now conclude that we seem to have emerged successful, where others have unfortunately failed. I now see no obstacles to concluding the study according to forecast, and I look forward to entering the final stage of the trial. I am very happy about our increased US presence and the enthusiasm and commitment of the new centres, and I am full of gratitude to the centres that have prevailed during the pandemic and delivered in spite of the difficult circumstances. I believe we are now entering an exciting phase for RhoVac!”

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 31-05-2021 13:00 CET.

For further information, please contact:

Anders Månsson – CEO, RhoVac AB

Phone number: +46 73-751 72 78

E-mail: info@rhovac.com

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. Therefore, RhoVac has launched a clinical phase IIb trial that will include at least 180 prostate cancer patients. The study will close in 2022 and it 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 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 180 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and United Kingdom) and the US.