Vaximm starts clinical study of first oral cancer vaccine
Intends to enrol up to 45 patients at the Heidelberg University Hospital
Vaximm, a Swiss biotech firm and Merck KGaA spin-off, has begun the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01.
The Basel-based firm intends to enrol up to 45 pancreatic cancer patients at the Heidelberg University Hospital in Germany for the placebo-controlled Phase I dose escalation study.
In addition to standard-of-care treatment, the patients will receive several doses of VXM01, which targets the tumour vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.
VXM01 stimulates the patients' own immune system to destroy tumour-associated blood vessels, which are essential for the growth of tumours. It is said to be the first therapeutic cancer vaccine in clinical development that does not target the cancer cells directly, but rather the tumour stroma, a structure that is required by solid tumours for their growth. VXM01 is also the first therapeutic cancer vaccine being investigated that is given orally and acts in the gut to induce an anti-tumour response of the immune system.
Dr Hubertus Schmitz-Winnenthal, principal investigator of the study, said: ‘In animal experiments, VXM01 showed an impressive anti-tumour 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, added: ‘With our lead product VXM01 entering clinical trials, we have achieved a very important milestone in the development of this therapeutic cancer vaccine. By characterising 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.’
