RhoVac presents 3-year follow-up results of the phase I/II study in prostate cancer
RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, announces today on October 5, 2021, that it has received and validated the top line results from its 3-year follow-up of the patients who took part in its phase I/II study that was concluded in 2018. The top-line results shows that the vast majority of patients still had undetectable PSA. Furthermore, the RhoC specific immune response has so far been assessed in 15 patients, and in these all but one patient who was a responder in the 1-year follow-up, still had RhoC specific immunity after 3 years. This exceeded expectations.
A 3-year follow-up study on the phase I/II patients was conducted at Zelo Phase I Unit, Bispebjerg Hospital in Copenhagen, Denmark in collaboration with the University of Tübingen in Germany and with Professor Klaus Brasso, Rigshospitalet, as Principal Investigator. 19 out of the 21 patients who completed the 1-year-follow-up to the phase I/II study, was identified and consented to participate in the 3-year-follow-up study. Out of these 19 patients, none of the patients had progressed significantly in terms of PSA nor progressed to other therapy. Indeed, all but three patients had undetectable PSA values (<0.1 ng/ml), and the patients who had a measurable PSA, had a longer PSA doubling time than they did when to entering the original study, indicating a slower progression. It should be noted that there was no placebo control group in the phase I/II study; therefore, we can not conclude with certainty that patients were doing better than they would have if they were not treated. We can only conclude that they are all doing well, in terms of non-progression of their cancers, considering the time that has passed since they had their surgery. We can also conclude that the PSA doubling time, a measurement of cancer progression, is very rarely extended in untreated patients.
Furthermore, the RhoC specific immune response has so far been assessed in 15 patients and in these, all but one patient who was a responder in the 1-year follow-up, still had RhoC specific immunity after 3 years. Given these results, further details on the immunity data will be produced and analysed in the coming months, aiming for a scientific journal publication.
Professor Klaus Brasso, Principal Investigator, Rigshospitalet, comments: “These results may well indicate that the vaccine could cause a delayed progression, and that postponement of other therapy would be possible. This hypothesis is being tested for confirmation in the ongoing phase IIb study, BRaVac, which is expected to yield results in the first half of next year”.
Juliane Schumacher, PhD, University of Tübingen, comments: “The number of patients who had maintained their RhoC immunity after 3 years exceeded my expectations”.
RhoVac CEO, Anders Månsson, comments: “To RhoVac the result of this study is truly excellent news. Though the number of patients in the follow-up study is of course small in comparison to the soon to conclude placebo-controlled clinical phase IIb study (BRaVac), we really could not have wished for better outcomes. The apparent lack of cancer progression in the long-term follow-up study, and especially the largely intact RhoC specific immune response, even after 3 years, are to us at least good indications of long-term effectiveness of our drug candidate, something which will be important for eventual phase III trials and commercialisation. Big kudos to the team behind this study.”
A previouly publisheds scientific publication on the study and its 1-year follow-up, completed in 2019, is available through the following link: https://jitc.bmj.com/content/8/2/e001157
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 05-10-2021 11:31 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.