RhoVac’s attempt to develop the first antigen vaccine for prostate cancer has ended in a phase 2 trial failure and forced the Swedish biotech to initiate cost cutting measures.
RV001, also known as onilcamotide, failed to significantly prevent or delay the progression of prostrate cancer in patients who saw biochemical recurrence, defined as a rise in prostate-specific antigen, despite having received curative therapy.
The disappointing results from the phase 2b BRaVac study, which comprised 180 patients across the U.S. and six European countries, have ended the Stockholm-based company’s high hopes for the drug after it received fast-track designation from the FDA in November 2020 off the back of positive phase 1/2 trial data.
RV001 is an immuno-oncologic antigen injection designed to stimulate T cells to identify and destroy cells that carry Rhoc, a protein that is overexpressed in metastatic cancer cells. While the new trial data did not indicate improved outcomes, RhoVac said it will undertake a more thorough analysis of the results.
The initial analysis “obviously offers little hope of a license or acquisition deal based on the results of this study alone,” RhoVac admitted. RV001 is the company's only drug in development, and, as a result of the study, the biotech will begin a cost minimization contingency plan.
"Even though we know that benchmarks state that the probability of success for a phase 2 project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint,” RhoVac CEO Anders Månsson said in a May 29 statement. “We will immediately minimize expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June."