RhoVac AB announces Database Lock in its clinical phase IIb trial of onilcamotide

RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today on May 10th, 2022, that its phase IIb study in prostate cancer, BRaVac, has reached “Database Lock”. This means that all data from the trial is now finally reported, cleaned and “locked” in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June.

RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after local curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. Patient recruitment was conducted in six European countries (Finland, Sweden, Denmark, the United Kingdom, Belgium and Germany) and in the United States. Recruitment ended in September 2021, when 180 patients had been included. The objective of the study is to show that onilcamotide can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted and no unexpected adverse reactions have been identified, confirming the anticipated safety of the drug. Now, the study has reached “Database Lock” with only a few weeks to go until the primary results are known. All results, including subgroup analyses, will be available in the summer.

CEO, Anders Månsson, comments: ”BRaVac started at the end of 2019, and much of the study has been run in pandemic conditions, which it has taken extraordinary efforts to overcome. We are happy to conclude that we have overcome all obstacles, that our intermediary safety reviews have all been positive, and now, after database lock, we await with excitement and anticipation what the primary results will bring in terms of efficacy.”

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 10-05-2022 20:50 CET.

For more information, please contact:
Anders Månsson – CEO, RhoVac AB
Phone: +46 73 751 7278
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 (onilcamotide) 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 has recruited more than 180 prostate cancer patients. The study will produce primary outcome results in the first half of 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. RhoVac is analysed by EDISON Group as well as by Swedish “Analysguiden”. Links to these analyses are found below:

Edison:                          https://www.edisongroup.com/publication/phase-iib-bravac-study-results-in-h122/30057
Analysguiden:              https://www.aktiespararna.se/analysguiden/Hitta-Bolag/rhovac/rhovac-ab

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, has recruited over 180 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany, and United Kingdom) and the US. After treatment, patient in the study will enter an Extended Follow-Up that could last until Q4 2022.