RhoVac’s reports positive results in the company’s phase I/II clinical study

1 August, 2018

RhoVac AB (“RhoVac”) reported today, August 1, 2018, positive top-line results on safety and on immune activation in their phase I/II clinical trial RhoVac-001 in prostate cancer patients.

In totally 22 prostate cancer patients received RV001 treatment over a period of approximately 30 weeks. The regimen was well tolerated and there were no treatment related grade 3, 4 or 5 reactions according to CTCAE (Common Terminology Criteria for Adverse Events). The primary end-point of the study was therefore achieved. No related allergic reactions to treatment and no treatment related SAEs (Serious Adverse Events) were reported. Local injection site reactions were noted; however, these reactions were all expected and the study confirmed that the reactions are reversible. In conclusion, the study meets its endpoint.

Totally 21 of the 22 enrolled patients were eligible for immune response assessment based on IFNγ ELIspot analysis, while analytical results from one patient were non-conclusive and therefore excluded from the final assessment. The immune response was analysed before -, two time during – and once, one month after completion of treatment. The result is that 86% (18 of 21 of the eligible patients) show a significant immune response to RV001 in samples taken during or after treatment. To qualify as a Confirmed Immune Responder in RhoVac-001 protocol, patients are required to show a significant response in two of the three samples taken during or after treatment. This was the case for all 18 patients showing significant immune response. In conclusion, the results confirm that a vaccine mediated immune response is established following treatment with RV001 and the dose administered in the study is biologically active.

Comments from RhoVac´s CEO, Anders Ljungqvist
-We are very excited about the results! In addition to the very high responder rate to the vaccination, we also saw that the responses were consistent over time, and we found that the vaccinations were safe and well tolerated by the patients. At this time, I would like to thank the Copenhagen Prostate Cancer Center at the University Hospital, Copenhagen, the phase-I unit Zelo at Bispebjerg and Frederiksberg Hospital plus DanTrials ApS and the T-cell monitoring group, Department of Immunology at the University of Tübingen, for a highly professional, timely and dedicated work. It has been an outstanding collaboration. Finally, but not least, I would like to thank the enrolled patients for participating in this clinical trial. Your commitment and compliance to treatment and planned visits have ensured that the trial have been completed on time and that data can be clearly interpreted.

The clinical trial
The clinical trial RhoVac-001 (ClinicalTrials.gov identifier: NCT03199872) is a phase I/II first-in-man trial studying the therapeutic cancer vaccine RV001. Patients prostatectomised, due to histologically verified adenocarcinoma of the prostate gland who were not being treated, were enrolled in the study and recruitment of the 22 patients was completed in July 2017. The primary endpoint of the study is to evaluate the safety and tolerability of the RV001 cancer vaccine and the secondary endpoint is to investigate the RV001-specific immunological response before, during and after vaccination. In addition to the now reported results, all patients treated are monitored for duration of immune response over a 12-month period following completion of treatment. This part of the study is ongoing and the results are expected to be reported mid-2019.

RV001 cancer vaccine
RV001 is a peptide based therapeutic cancer vaccine targeting the protein RhoC, which is known to be overexpressed in practically all cancer cells having a metastatic potential. The basic concept with RV001 cancer vaccine is to develop a treatment against initial formation and spread of metastatic cancer cells, specifically targeting the prevention against cancer relapse.

Prostate cancer
Prostate cancer is the fourth most common cancer in both sexes combined and the second most common cancer in men. An estimated 1.1 million men worldwide were diagnosed with prostate cancer in 2012, accounting for 15% of the cancers diagnosed in men, with almost 70% of the cases (759,000) occurring in more developed regions. The RV001 cancer vaccine is focussing on patients having completed treatment of the primary tumor, which commonly is surgical removal of all or part of the prostate gland. The adjuvant treatment is aiming at blocking or limiting relapse of prostate cancer.

For more information. Please contact:
Anders Ljungqvist – CEO, RhoVac AB
Telephone: +45 4083 2365
E-mail: alj@rhovac.com

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 1 August 2018.

About RhoVac AB
RhoVac AB conducts research and development of immunotherapeutic drugs. The Company’s main focus is the development of a therapeutic cancer vaccine with the potential to prevent or limit metastasis in cancer. RhoVac’s first drug candidate has completed pre-clinical phase and clinical phase I/II started in the spring of 2017. RhoVac has its headquarters at Medicon Village in Lund, Sweden. Since 2007, research is conducted primarily at the University Hospital in Herlev, Denmark, by a research team of world-class in its field. RhoVac is listed on Spotlight Stock Market, Sweden, a Multilateral Trading Facility (MTF), since March 2016. The share is traded under the ticker RHOVAC. Learn more at www.rhovac.com.