RV001 Granted FDA Fast Track Designation for Treatment of Prostate Cancer


The FDA granted a Fast Track designation to RV001 for the potential treatment of patients with prostate cancer.

The FDA has granted a Fast Track designation to RV001, a drug candidate from RhoVac, for the potential treatment of patients with prostate cancer, according to a press release from the developer of the drug.1

“We are extremely pleased and proud that our drug candidate, RV001, has earned Fast Track Designation by the FDA. We obviously appreciate the benefits that this might entail in terms of access to FDA advice and an accelerated approval process,” stated Anders Månsson, chief executive officer, RhoVac. “But also the fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority, obviously sends a clear signal of recognition of the drug's potential to all our would-be partners, which is something of great importance to us."

This designation will allow for the agent to be eligible for more frequent meetings with FDA, more written communication with the FDA, eligibility for Accelerated Approval and Priority Review designations, and a rolling submission, which all help to expedite the review of investigational drugs like this to facilitate the development of drugs for serious or life-threatening conditions. RV001 could fulfill an unmet need in the treatment landscape of prostate cancer.

Patients with prostate cancer currently do not have any available treatments for the prevention of recurrence, and these patients are also lacking assess to preventative therapy. Most patients undergo surveillance today, and only when patients are diagnosed with recurring and now metastatic disease, are they eligible to receive therapy, such as hormone therapy?

RV001 may lead to less patients experiencing recurrence of their cancer, and in those who do progress, the progression is delayed.

With proof of concept in prostate cancer, RV001 may also have the potential to treat other cancer types as well considering there is nothing prostate-specific about the rationale for this therapy.

The Fast Track designation application was submitted by the company at the end of September 2020. RhoVac stated the company is pleased to receive the designation less than 60 days later. The drug is currently under evaluation in a phase 2b clinical trial for the treatment of patients with localized prostate cancer (NCT04114825). The study will evaluate this treatment in more than 175 patients and is aimed to conclude by the start of 2022.

The clinical trial will evaluate the primary end point of time to prostate-specific antigen (PSA) progression and secondary end points, including safety by frequency and severity of adverse events (AEs), time to initiation of a subsequent antineoplastic therapy, proportion of patients showing a PSA response from baseline, and disease-free survival. The double-blind, placebo-controlled study will compare the treatment of RV001 in men with biochemical failure following curatively intended therapy for localized prostate cancer.

To be included in the trial, patients must have had biochemical recurrence within 3 years of radical prostatectomy or definitive radiotherapy and no distant metastasis. They also are required to have an ECOG performance status of ≤2, and they are ineligible if they have received a prior androgen-deprivation therapy (ADT) or are considered a candidate for immediate ADT. They also cannot enroll to the study if the patient is planning for salvage therapy with radiotherapy or radical prostatectomy.

A prior phase 1/2 study (NCT03199872) demonstrated that RV001 vaccine induced a potent and long-lasting T cell immunity in the majority of patients, with an excellent safety and tolerability profile. Overall, 18 of 22 patients developed a strong CD4 T cell response against the vaccine, which lasted 10 months after the last vaccine was administered.2

According to these findings, the treatment appeared well tolerated in the 22 patients who had previously undergone radical prostatectomy. No treatment-related AEs of grade 3 or worse severity were observed in the study.


1. RhoVac’s prostate cancer drug candidate, RV001, is granted fast track designation by the FDA. News Release. RhoVac. November 25, 2020. Accessed November 25, 2020. https://prn.to/375aNSg

2. Schauhmacher J, Heidu S, Balchen T, et al. Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial. Journal for ImmunoTherapy of Cancer.2020; 8:e001157. doi: 10.1136/jitc-2020-001157

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