CureVac GmbH initiates Phase 2b clinical trial of RNActive

CureVac GmbH has announced a double-blind, randomised Phase 2b clinical trial of its RNActive cancer vaccine, CV9104.

This will aim to treat patients with castration-resistant prostate cancer and the research will enrol up to 200 patients in eight European countries to study CV9104 in chemotherapy-naïve patients with asymptomatic or minimally symptomatic metastatic types of the disease.

The primary end point of the study is overall survival and eligible patients can enrol in the research through to November 2013.

CureVac is mixing the antigentic and adjuvant properties of mRNA's to develop novel and effective mRNA vaccines, which include modified and formulated mRNA with strong antigen expression, increased stability and enhanced immune-stimulatory activity.

Ingmar Hoerr, Ph.D., chief executive officer of CureVac, said: "We have shown that RNActive vaccines are safe and induce balanced humoral and cellular immune responses against multiple cancer antigens in what was a first-of-its-kind study of an mRNA vaccine.

"Because of the robust immune response induced by our mRNA vaccine, we expect CV9104 to yield significant clinical benefit for patients with advanced prostate cancer. We believe that RNActive vaccines have the potential to provide a safe and effective treatment option for patients with prostate cancer and other malignancies."

Arnulf Stenzl, M.D., medical director, Department of Urology, University of Tubingen, Germany, and the coordinating investigator of the study, also commented on the findings, saying: "This trial will validate the safety and investigate the clinical efficacy of CureVac's first-in-class mRNA-based cancer vaccine technology, RNActive, in patients with metastatic castration refractory prostate cancer."

CureVac is aiming to develop a new class of therapies based on breakthroughs in the understanding of mRNA, with the company's RNA technology platform being used to create novel therapeutic mRNA vaccines for cancer.

Posted by Ben Evans