Fast track designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants RhoVac greater access to FDA input throughout the regulatory process and makes RV001 eligible for accelerated approval and priority review, if it meets certain criteria.
With the fast track designation, RhoVac also may apply for a “rolling review,” in which the company submits sections of its biologic license application for review as they are completed, rather than all together after clinical testing finishes.
“We are extremely pleased and proud that our drug candidate, RV001, has earned fast track designation by the FDA,” Anders Månsson, RhoVac’s CEO, said in a press release.
“The fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority … 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,” Månsson said.
RV001 is a peptide-based medicine meant to prevent cancer recurrence and spread. The treatment mimics the Ras homolog gene family member C (RhoC), a protein that helps cancer cells migrate and take hold in other tissues, and stimulates the immune system to recognize and target cells producing this protein.
While these treatments historically have shown poor effectiveness against solid tumors, the goal of RV001 is to target the metastatic cancer cells, rather than the solid primary tumor. In this manner, the treatment is expected to eliminate spreading cells before they establish hard-to-treat tumors outside the prostate.
RhoC is highly expressed in cells of a wide variety of advanced cancers and metastases. If proven successful, RV001 might be effective against multiple cancer types.
An earlier Phase 1/2 clinical trial (NCT03199872) investigated RV001 as a way to delay or even prevent metastasis in 22 prostate cancer patients who had undergone surgery previously.
RV001 was found to be safe and well-tolerated, and to trigger a strong immune response. In that trial, 18 of 21 evaluable patients maintained immune responses to RV001 for at least 10 months following their last dose.
Also, among patients with measurable prostate specific antigen (PSA) levels — a biomarker of prostate cancer — most experienced slow increases in this measure over the 26 months of follow-up, indicating cancer-specific effectiveness. No cancer recurred in the trial’s patients.
Side effects were mild to moderate and consisted mainly of fatigue and reactions at the site of injection. None caused treatment to be discontinued in any patient.
That study is seeking up to 180 adult patients who had a biochemical recurrence (a rise in blood PSA levels) within three years of undergoing surgery or definitive radiation therapy, but who have neither distant metastasis nor local recurrence.
Participants will be assigned randomly to RV001, or a placebo, given as a series of subcutaneous (under-the-skin) injections. The main goal is to determine whether RV001 extends the time it takes for PSA levels to double (a measure of prostate cancer progression) compared with a placebo.
Secondary goals include the time to a new cancer treatment, reductions in PSA levels, time lived without signs of disease returning, and safety.
The study is estimated to end in early 2022.
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