Vaxxim, a Merck business, begins clinical studies for a new oral cancer vaccine. The drug is the first of its kind, the company states, targeting not the tumor cells directly but the tumor stroma via the diggestive system.
Basel/Switzerland; Mannheim/Germany – Vaximm, a spin–off of Merck, announced the start of clinical trials for its investigational oral therapeutic cancer vaccine VXM01. During a placebo controlled phase 1 study at the Heidelberg University Hospital (Heidelberg, Germany) up to 45 pancreatic cancer patients shall be given several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature, in addition to standard treatments, the company says. First results of the initial double blind study are expected for early 2013.
VXM01 was designed to stimulate the patients' own immune system to destroy tumor-associated blood vessels, which are essential for tumors growth. According to the company the drug 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. It is also the first oral cancer vaccine under investigation, acting in the gut where it induces 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's 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”.