The results speak for themselves when RhoVac presents its follow-up of the phase I/II study conducted three years ago at Rigshospitalet in Copenhagen. No metastases, no indication of a need for further treatment in order to maintain immunity, and no indication of significant development of PSA in treated patients. This is great news for the company, says CEO Anders Månsson when BioStock contacts him.
Lund-based RhoVac develops its drug candidate RV001 for the treatment of prostate cancer. The company is currently carrying out the phase IIb study BraVac which aims to evaluate the extent to which treatment with RV001 can prevent or limit the development of metastatic prostate cancer after surgery or radiation. The company recently announced that the study is fully recruited and that it expects results by the first half of next year at the latest.
Positive data from long-term follow-up
In 2018, the company’s phase I/II study, conducted at Rigshospitalet in Copenhagen, was completed. In a previous follow-up, the company has received good indications regarding the long-term effect of RV001. The results were acknowledged in the scientific journal Journal for ImmunoTherapy of Cancer and showed, among other things, that the drug candidate was safe and well tolerated and that a long-term immune response was generated in the vast majority of patients.
Strong results from the 3-year follow-up
During spring and summer, RhoVac has conducted yet another follow-up with 19 of the 21 patients who participated in the study, three years after completion of treatment. Of the 19 patients, none have developed any metastases, and none have undergone further treatment. Furthermore, no significant development of PSA has been recorded in any of them. In the vast majority (16 out of 19), their PSA could not even be detected (< 0.1 ng/ml). In addition, in patients with measurable PSA values, a longer PSA duplication time was seen than they had when they were included in the original study, indicating a slower development of the disease.
In 15 of the patients, the RhoC-specific immune response was also evaluated, and it could then be seen that only one of the patients with a RhoC-specific immune response at the 1-year follow-up was no longer had this response at the 3-year follow-up. This was better than expected as it is known that vaccinations, as well as cancer vaccinations, may need to be renewed in order for immunity to be maintained in the long term.
Commenting on the results lead investigator Professor Klaus Brasso at Rigshospitalet states:
»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.«
A comment from the CEO
BioStock contacted RhoVac’s CEO Anders Månsson to learn more about what these results mean for the project.
First of all, how do you view these results and their implications for the project?
– We are very pleased. It is of course difficult to draw far reaching conclusions that RV001 were to yield a better PSA-development than no treatment at all, as the phase I/II study was not placebo controlled. But we can state there is a lack of advanced cancer that looks very good. We are seeing extended PDA duplication times in patients with at all measurable PSA, and when it comes to the maintained immunity to RhoC after 3 years, the results are better than expected.
Of course, your most important results lie ahead of you, with the readout from BRaVac, but how important is it for the project that you now get such positive indications regarding the long-term effects of RV001?
– What potential takers are asking for is, of course, as large and as statistically robust data material as possible, which we will have from the phase IIb study BRaVac, but also follow-up of patients over a longer period of time, which we get from this study. All in all, we consider it an extremely strong position to have both.
Your previous results have been recognised in the research world. In which forum will your latest news be presented?
– Given the positive results of the 3-year follow-up, we will carry out further analyses and expect to submit the results for publication in a scientific journal next year.
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