RhoVac is currently conducting a phase IIb study with the drug candidate RV001 which will be used to prevent cancer recurrence and metastasis after initial curative treatment. In a first stage, the candidate is being evaluated in prostate cancer, but since its target protein RhoC is overexpressed in metastatic cells in several different types of cancer, the company also sees opportunities in other forms of cancer in the long term.
Full speed ahead in phase IIb study
Through the ongoing multinational phase IIb study BRaVac RhoVac is now evaluating the extent to which treatment with RV001 can prevent or limit the development of metastatic prostate cancer after initial surgery (prostatectomy) or radiation therapy. The idea is to determine that the treatment has the desired effect in the intended target group.
Despite the current Covid-19 pandemic, the study has managed to maintain momentum and on August 10th, it was announced that the first patient in the US has been included in the study. Carolina Urologic Research Center. The US thus became the fifth country in the order to begin patient recruitment for the BRaVac study, which has already happened in Denmark, Finland, Germany and Belgium. In total, the study will include at least 175 patients and in addition to the above-mentioned countries, clinics in Sweden and the UK will also be included.
BRaVac is expected to be fully recruited by the end of the year and after active treatment and necessary data management, RhoVac expects to be able to publish the study results around the end of 2021/22.
Expanded scientific advice will show the way forward
RhoVac has previously communicated that the study will be the last development phase that the company will conduct under its own auspices, which is why it has been intensifying its partnership discussions for some time. In a previous interview with BioStock mentioned CEO Anders Mansson that such discussions have currently been initiated with around 20 stakeholders.
As part of these efforts, the company recruited two leading experts in prostate cancer to its scientific council in June; Professor Emeritus Per-Anders Abrahamsson vid University of Lund and professor Klaus Brasso vid University of Copenhagen.
CEO Anders Månsson commented on the announcement;
»I am very pleased that we have succeeded in recruiting such important names in international urology as Professors Abrahamsson and Brasso. In addition to the purely scientific advice they can contribute, the recruitment also creates great credibility and attention around the RV001 project and the company, and this will mean a lot for our business process going forward.«
Professor Brasso leads the BRaVac study
Per-Anders Abrahamsson got to know BioStock's readers during a interview in July, and now we have also had the pleasure of meeting Klaus Brasso. Professor Brasso is active at Department of Clinical Medicine vid University of Copenhagen and also sits on the board of directors of Copenhagen Prostate Cancer Center (CPC) at Rigshospitalet in Copenhagen, a research center focusing on the investigation and treatment of prostate cancer.
Professor Brasso has authored over 150 scientific articles and has extensive experience in clinical trials in urology across all phases. He is also the Principal Investigator (PI) for RhoVac's ongoing Phase IIb study.
Klaus Brasso, as stated, you are the PI for the BRaVac study. How did that come to be?
- It was the result of our involvement in the phase I study conducted during last year. In that study we tested safety and side-effects and found that the RV001 vaccine was well tolerated. Furthermore, although very preliminary, the results indicated that disease progression may be postponed, which led to the ongoing study.
Running the study means that you are familiar with both RV001 and RhoVac as a company. What is it about the drug candidate that you find interesting?
– Once prostate cancer progresses following curatively intended therapy, the patient faces several opportunities, either salvage radiation following surgery or endocrine therapy following radiation. These treatments all come with side-effects, and new treatments, especially if not connected with side-effects, are warranted.
With RV001, RhoVac hopes to prevent disease recurrence that would otherwise occur in a large proportion of prostate cancer patients treated with surgery or radiation. What are the treatment options for this patient group today, and what shortcomings do you see that these alternatives have?
– As stated before, the major problem with handling recurrences following curatively intended treatment of localized or locally advanced prostate cancer is the side-effects. Either the toxicity following salvage radiation or the long-term consequences of endocrine therapy. RV001 might not provide an opportunity to completely prevent recurrences, but what we are testing is in effect if RV001 can significantly postpone progression.
In your opinion, what would it mean, for doctors as well as patients, if RV001 proved to have solid metastatic preventive effect?
- We know that the prognosis following recurrence depends on several factors, one of these is the increase in prostate specific antigen (PSA) as a marker of disease burden. The increase correlates to the time for further progression, and if one can in some way reduce the increase – ie delay PSA progression – it is likely to transfer into a clinical benefit, postponing the time for initiating the next line of therapy.
Based on your experience from previous studies of the same kind, what do you expect the BRaVac study to show? Duck how do you view the potential of RV001 in general?
- It is far too early to address the question, as the study is still ongoing. Our preliminary experience had some results indicating that the vaccine may be effective, and the natural consequence of that finding, in combination with the knowledge about the antigen itself, is to perform the phase IIb trial.
- If, as we hope, the study turns out to be successful, one might foresee a number of subsequent studies to see whether the biochemical delay transfers into a clinically more relevant endpoint. Of course, it would be relevant to expand into other stages of the disease as well.
Finally, what will be your role as a scientific advisor for RhoVac?
- As I see it, my primary role is to continue the ongoing study, and to guide the initiation of the final stage studies that would be able to bring the compound into routine clinical use.
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