RhoVac’s phase IIb study in prostate cancer , BRaVac, failed to meet its primary endpoint

RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, regrets to announce today on May 29th, 2022, that its phase IIb study in prostate cancer, BRaVac, in spite of the previous positive results related to the compound, failed to demonstrate RV001 (onilcamotide) superiority over placebo in preventing progression in patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Progression was defined as either a doubling of PSA, clinical recurrence, or death. RhoVac will undertake a more thorough analysis of the results, and a clear plan on how to proceed will be communicated end June. The primary outcome analysis, however, regrettably offers little hope of a license or acquisition deal based on the results of this study alone.  

RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001 (onilcamotide) late 2019, in prostate cancer patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Positive phase I/II data offered significant hope, and in November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. The objective of the BRaVac study was to show that onilcamotide could 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 events have been identified, and the end trial results also confirm the anticipated safety of the drug candidate.

On efficacy however, BRaVac, the first placebo controlled study of the drug candidate, failed to deliver on its primary endpoint, which was to demonstrate drug candidate superiority over placebo in reducing the risk of progression, and the primary results did not indicate any significant finding on improved outcomes for the studied patients. RhoVac will now undertake a more thorough analysis of the study results, but the primary outcome analysis obviously offers little hope of a license or acquisition deal based on the results of this study alone. RhoVac will now execute on a cost minimisation contingency plan, while conducting further analyses of the results, aiming to come up with clear recommendations on the future of the project and next steps end June.

RhoVac CEO, Anders Månsson, comments: “Even though we know that benchmarks state that the probability of success for a phase II project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint. We will immediately minimise expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June.”

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 29-05-2022 19:53 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 onilcamotide 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, BRaVac, that ha recruited more than 180 prostate cancer patients. The study was designed to show, with statistical significance, the effect of onilcamotide 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 oniclamotide 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.

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