The placebo-controlled phase I dose escalation study intends to enroll up to 45 pancreatic cancer patients at the Heidelberg University Hospital (Heidelberg, Germany). In addition to standard-of-care treatment, the patients will receive several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.
The investigational therapeutic vaccine VXM01 is designed to stimulate the patients' own immune system to destroy tumor-associated blood vessels, which are essential for tumors growth. It is the first therapeutic cancer vaccine in clinical development that does not target the cancer cells directly, but rather the tumor stroma, a structure that is required by solid tumors for their growth. VXM01 is also the first therapeutic cancer vaccine being investigated, which is given orally and which acts in the gut to induce an anti-tumor response of the immune system.
PD Dr. Hubertus Schmitz-Winnenthal, principal investigator of the study, commented: “I am delighted about the transition of this therapeutic cancer vaccine into clinical evaluation. In animal experiments conducted by us and others, VXM01 showed an impressive anti-tumor activity. We are very keen on exploring the safety and potential efficacy of this vaccine in inoperable pancreatic cancer patients, as a first step in the clinical evaluation of VXM01”.
Dr. Heinz Lubenau, General Manager of VAXIMM GmbH, a fully owned subsidiary of VAXIMM AG in Germany, commented: “With our lead product VXM01 entering clinical trials, we achieved a very important milestone in the development of this therapeutic cancer vaccine. By characterizing the safety, tolerability, immunogenicity and other clinical parameters of the vaccine in patients, we aim to establish a solid basis for the further development of VXM01 in several different cancer indications. In addition, this trial may pave the way for the use of the technology platform in other potential applications”.
Dr. Klaus Breiner, chairman of VAXIMM’s board of directors, and a Managing Partner at BB BIOTECH VENTURES added: “We are glad to see VAXIMM’s successful transformation into a clinical stage company. We are also grateful to PD Dr. Schmitz-Winnenthal for the pivotal role he played in the spin-off of this project from Merck, and continues to play in bringing this investigational therapeutic vaccine now from the bench to the bedside”.