RV001--the Rhovac Vaccine--A Vaccine Targeted Against Metastasis

[NPfisherman]

After the immunotherapy intro, I would like to discuss RV001--Rhovac's vaccine for PCa that showed a solid ability to induce an immune response. Targeted against metastasis, this vaccine targets Rho C, a protein that helps allow cancer cells to migrate and invade other tissues. While most vaccines are targeted specifically toward tumors, this vaccine is targeted towards migrating tumor cells to kill them and prevent metastasis/ migration. RV001, a peptide antigen is given subcutaneously (a shot, not IV) which induces an immune response against RhoC. Rho C is what allows tumor cells to migrate and the level of Rho C is inversely proportional to survival in Pca-see below:

cancerres.aacrjournals.org/...

Some info on the vaccine from the company describing its' action in more detail::

rhovac.com/product-developm...

It has completed Phase I and in that trial, Eighteen of 21 patients (86%) developed a strong CD4 T cell response against the vaccine, which lasted at least 10 months following the last vaccination. In most cases, vaccine-reactive T cells were detected after 4 vaccinations (visit 6). In strong responders, T-cell frequencies reached a plateau at visit 13 (after 11 vaccinations), which lasted for 13 months postvaccination. Two patients in the study essentially had a doubling of their PSADT.

Safety is always a concern but in this trial there were no serious adverse effects. The vaccination against RhoC was safe for all patients over the complete treatment period. Side effects were predominantly injection site reactions and fatigue (grade 1/2). These events are most likely related to the adjuvant and carrier Montanide ISA-5132 and did not necessitate specific medical intervention.

RhoC vaccination to impair tumor spreading might also synergize with many tumor vaccines (such as those targeting patient-individual tumor antigens) or other therapies, and become a valuable approach for PCa and for further tumor entities.

The Phase 1 study:

jitc.bmj.com/content/8/2/e0...

Another article provided byTheTopBanana, who has been in contact with Rhovac and will hopefully provide information from that contact-see below:

sperlingprostatecenter.com/...

The potential to be used in combination with other interventions-vaccines, CAR-T, Sipulcel-T, CPI's, with SOC make this vaccine a potentially powerful game changer in life expectancy and perhaps a role in a cure.

With these excellent results achieved, RhoVac® has started a large clinical phase IIb prostate cancer study, engaging some 30 clinics presumably both in Europe and in the USA, and enrolling some 175 patients. RhoVac is currently running a Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac). US locations in Maryland, Nevada, and South Carolina--RECRUITING

clinicaltrials.gov/ct2/show...

This vaccine has outstanding potential to be a real game changer, especially in combination. I advise everyone to keep it on the radar.

Don Pescado

[GreenStreet]

Thanks to you ( and the TopBanana) for bringing this to our attention. It does seem very promising and like you I hope it will also be effective in combination. I hope that the necessary authorities continue to fast track it. I just hope that if it works its authorisation does not get bogged down by the time taken to definitively prove a long term survival cost benefit. I hope that extending PSA doubling time and proving a slowing up of progression as well as showing no significant side effects should be enough until further long term survival benefits can be measured. I think the whole vaccine area shows great promise but we are perhaps only in the foothills on this?

[NPfisherman in reply to GreenStreet]

I think the fact that it has been given fast track status as there are no treatments for preventing metastasis is a solid indicator that this drug should gain approval quickly. Quickly being a relative term of 4 years or so. The fact that trials will be in the US will mean that people who are desperate may be able to use "right to try" to get it.

targetedonc.com/view/rv001-...

Thanks for your reply...

Fish

[NPfisherman]

Here are the sites and contacts listed from the trial, and you may be right regarding FLA, but not posted yet...

United States, Maryland

Chesapeake Urology Research Associates Recruiting

Towson, Maryland, United States, 21204

Contact: Richard Levin, Dr

United States, Nevada

Comprehensive Cancer Centers of Nevada Recruiting

Las Vegas, Nevada, United States, 89169

Contact: Nicholas Vogelzang, MD

United States, South Carolina

Carolina Urologic Research Center Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contact: Neal Shore, MD

I hope TheTopBanana can chime in here on FLA as she has been in contact with the company also. I hope someone here can get into this trial Thanks for your reply...

Fish

[NPfisherman]

Appreciate the reply.. I wish I could get on but I do not qualify. I am watching the ADXS-504 trial in hopes I might qualify. I have done one clinical trial and another is in my future for something gone wrong, but who knows if I'll need it. Clinical trials are how we get answers... Kudos to those that have done trials...

Fish