Completion of the recruitment for RhoVac’s Phase IIb study expected in September
RhoVac continued its work on the drug candidate RV001 in the second quarter and was able to present several news items in the project. Results from the long-term follow-up of the Phase I/II study are expected in the autumn, an important milestone pending next year’s results reading in the BRaVac study. BioStock contacted the company’s CEO Anders Månsson to get his view of the quarter passed and what he sees ahead.
Lund-based RhoVac develops the drug candidate RV001 for the treatment of prostate cancer. The candidate targets the protein RhoC with the aim of preventing metastasis of cancerous tumours in patients previously treated by surgery or radiotherapy directed at the primary tumour. The Phase IIb study BRaVac is currently underway in seven countries to evaluate the candidate’s potential to slow or prevent disease progression to a metastatic state.
This summer, an interim analysis of the safety of the study concluded that patient safety is excellent and that the study could continue without any changes.
Recruitment is expected to be completed in September
The company notes that the effects of the pandemic have decreased significantly over the past quarter and now expects to be able to complete the recruitment for the large phase IIb study, BRaVac, in September. It also notes that the initiatives taken early on when adding more US clinics have been just the right way to go and RhoVac’s CEO Anders Månsson highlights in particular the Fast Track Designation that the company received from the FDA last year as a strong contributor to make it possible. A prominent example that BioStock has reported on earlier is the prestigious Mount Sinai Hospital in New York, that chose to join the study in the spring.
The fact that RhoVac has been able to continue the study at all, when many other companies have had to pause or even discontinue their studies, should also be seen in the light of the fact that patient flow in oncology in hospitals around the western world during the pandemic has decreased by between 25 and 50 percent, according to IQVIAS’ report “Global Oncology Trends”.
Results await from long-term follow-up
During the autumn, the company is expected to present the results of the three-year follow-up, which began this summer and is carried out on patients who participated in the company’s Phase I/II study. At the same time, work is underway on complementary pre-clinical studies and formulation development, which according to the company is expected to be completed well in advance of reporting BRaVac.
BioStock has contacted RhoVac’s CEO Anders Månsson to ask some questions about how he sees the quarter passed.
First of all, Anders, what would you particularly like to highlight when you report your second quarter 2021?
– I think that the numbers that are now available regarding exactly how much the pandemic has affected the treatment of oncology patients put our moderate delays in the Phase IIb study in a new light. I think we should be immensely proud of what has been achieved in this study in difficult circumstances. And the fact that we so quickly put the focus on the US for the expansion of the number of study centres I think is an investment that will pay off well.
– Financially, the half-year report shows that we now have better speed in patient recruitment, which is the part of the business that drives the most costs, and that we still have finances to drive the study to the finish line. And this has been achieved at the same time as we have significantly raised our profile in the US.
What can you tell us about the smaller development projects that run parallel to BRaVac?
– We are continuously working on a formulation development that aims to make the injections with RV001 more user-friendly once they are to be sold in the market. Furthermore, we are working on preclinical development. Among other things, it is about showing that T cells activated with RhoC-specific antigen can kill metastatic cancer cells of several different types, i.e. not just prostate cancer cells.
– This has been shown in the past for melanoma, breast cancer and colon cancer, but we are redoing the experiments and including even more cancers. I expect us to compile and communicate the results of all pre-clinical research by the end of Q1 next year.
– And, as I said, we are doing a three-year follow-up of the patients who participated in the Phase I/II trial, and we expect to publish these results as early as October. All in all, I think we are working on a very good portfolio with supporting data on the project. Of course, this does not exclude the fact that we must also have good results in phase IIb in order to succeed, but it increases the value of what we have to offer in the desired outcome of the BRaVac study.
What activities will be important to you now in autumn and winter?
– We will conduct further market research to specify our recommendations to a potential partner regarding appropriate studies in cancers other than prostate cancers, i.e. regarding other major cancers where we believe that RV001 could have an important role to play in terms of epidemiology and competitive situation.
– And as we close the recruitment to the Phase IIb study, get the results of the long-term follow-up, and see the pandemic-related travel restrictions ease, it is also time to meet our potential partners again for new updates and to take our dialogue to the next level.
– With the positive safety analysis from this summer, and with the study fully recruited, the risk in the project has also decreased. And with only about a year to go until the Phase IIb results, it is also reasonable to assume that interest in RhoVac and RV001 will increase further. It will be an exciting autumn and winter.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
