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The cancer immunotherapy company RhoVac is currently conducting a phase IIb study with RV001, the company’s candidate for the treatment of prostate cancer. Yesterday it was announced that the company has received approval for a study aimed at expanding knowledge about the drug candidate’s long-term effects, through a long-term follow-up of patients who participated in a previous clinical phase I/II study. The treatment part of that study was completed in 2018 and the company has now received approval for a long-term follow-up of the study participants. BioStock contacted Anders Månsson, CEO of RhoVac, to find out more.

RVOO1, Lund-based RhoVac’s drug candidate, is being developed for the treatment of prostate cancer. The goal is for the candidate, that targets the protein RhoC, to be able to prevent metastasis of cancerous tumours in patients previously treated by surgery or radiation therapy aimed at the primary tumour. A phase IIb study with RV001 is currently underway in seven countries in order to evaluate the candidate’s potential to slow down or prevent disease progression to a metastatic condition.

Long-term follow-up to strengthen the evidence for RV001

However, RhoVac is not content with just the ongoing phase IIb study, and is now taking the opportunity to collect additional data on the candidate and its potential. The company has previously conducted a clinical phase I/II study in prostate cancer in Denmark. The treatment part of that study ended in 2018 and was followed by a one-year follow-up that ended in 2019. The study yielded positive results that showed that the candidate was safe, well tolerated and gave rise to a relevant and long-lasting immune-RhoC-specific immune response in 86 per cent of patients. There were also indications that disease progression was slowed down in participants who were not in full PSA remission when the study began.

The company has now received permission to carry out a long-term follow-up where it will look at the extent to which patients still have a relevant level of RhoC-specific immune response, their PSA development and the extent to which they have moved on to another treatment. The study will be carried out in the coming months and BioStock has spoken with RhoVac’s CEO Anders Månsson to find out more.

Anders Månsson, vd RhoVac

Anders, can you tell us a little more about why you choose to do a long-term follow-up? 

– Our treatment is intended to provide long-term protection against metastasis, a protection that is far beyond the treatment period and ideally throughout life. So now that we have these patients who received their treatment three years ago, it is tempting to examine how they feel now, to what extent they still have a relevant RhoC-specific immune response, what their PSA development looks like, and if they have needed to supplement with other therapy.

What do you hope the follow-up will show?

– We hope, of course, that the follow-up will show that very few patients have experienced a disease progression, and that they feel well in every way.

Finally, can you say something about how the phase IIb study is progressing?

– As previously communicated, we expect to close the recruitment in Q3 and enter the home stretch of the study. The other smaller development projects that we are running in parallel are also entering the final stages so that we can complete all results by the middle of next year. We expect to have the results of this long-term follow-up of the patients who participated in phase I/II study three years ago, already this autumn.

 

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.

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