reports
- Sean Conroy
RhoVac - On the home straight
RhoVac’s Phase IIb BRaVac trial has been fully enrolled since September 2021. According to the latest guidance, key results are expected in May or June 2022, which is the most significant catalyst of the investment case so far. The BRaVac trial is investigating RV001, a tissue-agnostic cancer immunotherapy now known as onilcamotide, in prostate cancer patients with localised disease who have relapsed after treatment with curative intent. There is a lack of treatment options in this stage and pat...
- Sean Conroy
RhoVac - Phase IIb BRaVac study results in H122
After months of industry-wide turbulence due to the COVID-19 pandemic, RhoVac has emerged with a flurry of positive news. In July 2021, the Safety Monitoring Committee gave the green light to continue the lead Phase IIb trial investigating the RV001 cancer vaccine in prostate cancer patients. Patient recruitment was finalised in September 2021, which means the trial is now in its final months, with top-line data expected in H122. Most recently, RhoVac announced that it had retained an internatio...
- Sean Conroy
RhoVac - Phase IIb BRaVac study results in H122
After months of industry-wide turbulence due to the COVID-19 pandemic, RhoVac has emerged with a flurry of positive news. In July 2021, the Safety Monitoring Committee gave the green light to continue the lead Phase IIb trial investigating the RV001 cancer vaccine in prostate cancer patients. Patient recruitment was finalised in September 2021, which means the trial is now in its final months, with top-line data expected in H122. Most recently, RhoVac announced that it had retained an internatio...
- Sean Conroy
RhoVac - COVID-19 vaccines versus RV001
While returning clinical practice to normality is unequivocally desired by all stakeholders, the somewhat paradoxical consequence of the global roll-out of COVID-19 vaccines has been an unavoidable disruption to the routine administration of other vaccines. RhoVac reported in March 2021 that as the COVID-19 vaccine was being rolled out in the age brackets of the ongoing Phase II BRaVac trial, the treatment with RV001 had to be delayed, albeit only by one quarter. The trial readout is still achie...
- Sean Conroy
RhoVac - COVID-19 vaccines versus RV001
While returning clinical practice to normality is unequivocally desired by all stakeholders, the somewhat paradoxical consequence of the global roll-out of COVID-19 vaccines has been an unavoidable disruption to the routine administration of other vaccines. RhoVac reported in March 2021 that as the COVID-19 vaccine was being rolled out in the age brackets of the ongoing Phase II BRaVac trial, the treatment with RV001 had to be delayed, albeit only by one quarter. The trial readout is still achie...
- Sean Conroy
RhoVac - Fast Track designation granted by FDA
Following the submission of an application in September, the US FDA has now granted Fast Track designation to RhoVac’s lead drug RV001. Although we had expected this, it indicates a third-party validation for RhoVac and its ongoing clinical programme. Importantly, this designation should make RV001 more appealing to potential partners, given it eases some of the regulatory processes ahead. Other developments include the news that RhoVac’s Phase I/II data have been published in a peer-reviewed ar...
- Sean Conroy
RhoVac - Good execution in challenging times for industry
On the back of a crystal-clear R&D strategy, to conduct a proof-of-concept study and then seek a partnership deal, RhoVac completed a successful fundraise in June 2019 and started enrolling patients in the Phase IIb BRaVac study in November 2019. Due to the COVID-19 pandemic full enrolment is now expected by end-2020 vs the original target of Q320. In our view the delay is modest and easily covered by the existing budget. Clinical trial centres are up and running, including in the US, and treatm...
- Sean Conroy
RhoVac - Limited impact from COVID-19 pandemic
According to the latest update from RhoVac, the COVID-19 pandemic has had limited impact on it to date. No patients have dropped out of the ongoing Phase IIb BRaVac study with RV001, a cancer immunotherapy targeting RhoC, in prostate cancer. The company expects full recruitment will be delayed by only three months to end-2020. RhoVac added that the delay is manageable within the existing budget, so we do not expect it to have a significant effect on the investment case. The company is expanding ...
- Sean Conroy
RhoVac - Phase IIb study progressing to plan
The key takeaway from RhoVac’s Q419 results update released on 11 February 2020 was confirmation that the Phase IIb BRaVac study is progressing according to plan. All patient recruitment centres are expected to be up and running by May 2020. The trial should be fully enrolled (n=180) in September 2020 and key interim results, including primary endpoint assessment, are expected in H221. RhoVac has now received the first part (SEK12m) of the EU Horizon grant of €2.5m (c SEK27m). The existing a...
- Sean Conroy
RhoVac - Phase IIb BRaVac study enrolling patients
RhoVac’s Phase IIb BRaVac study with RV001 (a cancer immunotherapy against RhoC) is up and running with patients being recruited in six European centres since November 2019. In total, over 175 prostate cancer patients, who experienced biochemical failure after a curative therapy (surgery or radiation therapy), are expected to be enrolled by the end of Q320. The primary endpoint is time to PSA doubling or clinical progression and key interim results are expected in H221 (the treatment part of t...
- Sean Conroy
RhoVac - Executive interview
is developing RV001, a cancer immunotherapy designed to prevent or limit metastasis by activating T-cells against cells with metastatic potential. The therapy contains fragments of the protein RhoC, which is overexpressed in cells with metastatic potential across a range of cancers. The ongoing Phase IIb study in prostate cancer is fully funded and results are expected around mid-2021. RhoVac’s strategic aim is to secure a partner for the late-stage development of RV001. In this Anders Månss...
- Sean Conroy
RhoVac - Funded to execute Phase IIb study as planned
The past few months have been transformative for RhoVac. The company completed a large rights issue, published final follow-up results from its Phase I/II trial with RV001 in prostate cancer and is about to enrol the first patient to a new controlled efficacy Phase IIb trial. On the corporate side of the business, a new CEO was appointed, bringing a wealth of business development expertise, a strategic fit given RhoVac’s priorities over the next two to three years. The recently received EU Hor...
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