While testing its candidate RV001 in prostate cancer patients in a phase IIb trial, Lund-based RhoVac is making plans to out-licensing the project. To set the stage for a possible deal, comprehensive market research has been conducted to provide guidance on the medical need for a cancer relapse vaccine in additional cancer indications. Overall, the company concludes that there is great need for a vaccine that prevents tumour recurrence and highlights two cancer indications as particularly interesting.
A potential out-licensing is getting closer for development company RhoVac and its drug candidate RV001, which was recently given the scientific name onilcamotide. The candidate is being developed as a cancer treatment designed to attack the disease in its weakest state, after the primary tumour has been removed and before secondary tumours have developed.
Read more about the clinical concept for RV001 here.
The most crucial milestone to look forward to is, of course, the results of the ongoing phase IIb study BRaVac, which examines the candidate’s efficacy in patients with prostate cancer. While waiting for the results, which are expected during the first half of 2022, the company is collecting and preparing documentation about the candidate to be able to offer a potential partner a complete and comprehensive data set.
Market research highlights a great medical need
As part of these efforts, RhoVac is in the process of completing both formulation development and complementary preclinical studies. The company is also upgrading its so-called data room, which will eventually be subject to due diligence, i.e., it will be reviewed by potential partners. Another activity that has been underway during the autumn is a market research project aimed to clarify the overall potential of onilcamotide, in addition cancer indications aside from prostate cancer.
Although the market study states that there are adjuvant treatments available in several cancer indications aimed at preventing metastasis and relapse, these are found to be associated with serious side effects. Given their profile, existing adjuvant treatments can only be given to high-risk patients. According to RhoVac, this opens for introducing a relapse prevention treatment with a better safety profile to a broader patient group.
Two indications are seen as particularly interesting
When RhoVac published the conclusions of its market research, two cancer indications were highlighted as particularly interesting to explore as potential new target indications for onilcamotide, namely kidney and bladder cancer. According to the company, these two cancer indications have large target group synergies with prostate cancer. The majority of kidney and bladder cancer patients present with local cancer at the time of diagnosis, and the cancer spreads in 20 – 50 per cent of these cases, despite local curative treatment.
According to RhoVac, there is currently no adjuvant treatment available for kidney cancer. Patients with bladder cancer, on the other hand, can be offered either chemotherapy or the immunotherapy Bacillus Calmette-Guérin, but both options are associated with serious side effects.
BioStock has talked to RhoVac’s CEO Anders Månsson to find out more about what the results of the market research imply for the RV001 project.
First of all, in what way do the conclusions from the market research impact your quest to reach a deal for RV001?
– The market research gives us quantitative data on the potential for a cancer vaccine, with a mild adverse effect profile that can prevent recurrence of cancer and metastases after curative local treatment, i.e., the profile that we believe matches that of onilcamotide. Prostate cancer has enormous potential in itself as an indication for a cancer vaccine – it is one of the most common cancers in the world – but it is of course important to reflect on the full potential to a potential partner.
You have identified a potential for your candidate to be given as a preventive treatment for a broad patient group in several cancer indications. How likely is the scenario that RV001 could replace more traditional adjuvant treatments that have a poorer side effect profile, and if so, what time horizon should be borne in mind in this context?
– If RV001 is shown to work well in prostate cancer, which we are now testing in the phase IIb trial, there is a very high probability that the product can work in other cancers as well, since there is nothing about oncilcamotide that is specific to prostate cells.
– However, before the medicine can come on the market in any cancer indication, phase III studies are most likely required. With that said, our Fast Track status can speed up a potential approval. Still, we do not want to speculate on how much time can be saved until we have the phase IIb results at hand, which will be in the next six months.
Kidney and bladder cancer are identified as interesting indications to explore further with RV001. Are these projects that RhoVac will consider initiating, or will these findings primarily serve as a guide for a future partnernership?
– Our plan is unmistakably to aim for a partnership deal after Proof-of-Concept in prostate cancer, which we hope to achieve as early as the first half of next year. We are open to explore the exact terms of such a partnership. It could be a straight acquisition, or some kind of licensing deal. But we do not envision RhoVac to independently pursue the next development steps.
– Late-stage development requires a lot of capital and it is part of the pre-launch of the drug. Late development stages should therefore be driven by large companies that have financial strength as well as both expertise and commercial presence within the therapy area.
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