RhoVac reports interim results on immunological response with RV001

Today, 18th November 2019, RhoVac AB ("RhoVac") reports interim results from ongoing immunological studies at University of Tübingen, Germany concluding that treatment with RV001 can activate CD4+ T-cells and also CD8+ T-cells.

In July 2019 RhoVac published results on the follow-up phase of the phase I/II clinical study and in relation to the immunological response it could be concluded that 18 patients showing significant treatment related immunological response at completion of treatment. All 18 patients still showed significant response at 3-, 6- and 9-months follow-up. At the 12-months follow-up, 17 out of the 18 responding patients still showed significant immunological response.

Ongoing immunological studies at the University of Tübingen now confirm that treatment with RV001 can activate CD4+ T-cells and also CD8+ T-cells. Confirmation that the drug candidate RV001 can activate CD4+ T cells is important for the clinical value of the treatment. This has been demonstrated in a number of scientific publications of which some are referenced below:

• Doonan et al (2010), demonstrated that “activation of CD4+ T cells is required to stimulate and prolong CD8+ T cell activity, and for the development of long-lasting tumor specific memory T cells”.
• Quezeda et al (2010) concluded in their study that “results highlight the relevance of the CD4+ T cell compartment, and particularly of cytotoxic CD4+ T cells, in cancer immunotherapy, while providing evidence that T cell differentiation in vivo may afford advantages over current approaches using differentiation and expansion in vitro”.
• Haabeth et al (2014) also concluded that beside CD8+ T cells commonly known as being able to eliminate target cells, CD4+ T cells also have the ability to directly eliminate tumors via T Cell Receptor and peptide:MHC-class II interaction (the pathway linked to CD4+ T cells) and/or to eliminate tumor cells indirectly via the release of immunomodulatory molecules activating surrounding immune cells.

For these reasons the MHC class II tumor antigen presentation pathway (the pathway linked to CD4+ T cells) must be utilized for therapeutic cancer vaccines to have a high clinical value, and interim results strongly indicate that RV001 is well capable of this.

Comment from RhoVac's CEO, Anders Månsson: 

- Confirmation of the immunological response concluded based on interim results is obviously important data for the ongoing development of the drug candidate RV001. I am looking forward to the continued collaboration with the team at University of Tübingen.

For further information, please contact:

Anders Månsson – CEO, RhoVac AB

Phone number: +46 73-751 72 78

E-mail: info@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 18th November 2019.

About RhoVac AB

RhoVac was established as a private company in Denmark in 2007. Under this company, the basic development steps for the drug candidate RV001 were undertaken. In 2015 the Swedish RhoVac AB was formed, which is now headquartered and in 2016 the company was listed on the then Aktietorget in Sweden (now Spotlight Stock Market). RhoVac has now passed the early stages of development. In 2018, the first clinical trial (phase I / II) was completed in prostate cancer, demonstrating that RV001 has good safety and is well tolerated, and that the drug provides the expected immune response that will exert its effect on the cancer cells. The strong immune response has also been shown to last over time. Therefore, RhoVac is immediately launching a major Phase IIb clinical trial that will include at least 175 prostate cancer patients. The study, which is expected to be completed in 2021, is designed to show, with statistical significance, the effect of RV001 in preventing disease progression in prostate cancer after surgery or radiation to the primary tumor. RhoVac is listed on Spotlight, Sweden, a Multilateral Trading Facility (MTF) since March 2016. The share is traded under the ticker RHOVAC. Read more at www.rhovac.com