Basel (Switzerland), Mannheim (Germany) – VAXIMM AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced last week that it completed enrollment in the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01. The randomized, placebo-controlled, double-blind Phase I/II dose escalation study enrolled 45 patients with inoperable pancreatic cancer at the Heidelberg University Hospital (Heidelberg, Germany). In addition to standard-of-care treatment, the patients received several doses of VXM01, a therapeutic cancer vaccine targeting the tumor vasculature. The results of the first, blinded part of the study are expected in the first quarter of 2013.
The investigational therapeutic vaccine VXM01 is designed to stimulate the patients’ own immune system to destroy tumor-associated blood vessels. It is the first therapeutic cancer vaccine in clinical development that does not target the cancer cells directly. Instead, it addresses the tumor stroma, a structure essential for growth and metastasis formation of solid tumors. VXM01 is also the first investigational therapeutic cancer vaccine that is administered orally and that acts in the gut to induce an anti-tumor response of the immune system.
“I am pleased how fast we were able to enroll this study,” said PD Dr. Hubertus Schmitz-Winnenthal, principal investigator of the study. “It confirms the high medical need in inoperable pancreatic cancer and highlights the attractiveness of an oral vaccination as a potential treatment.”
“We are very encouraged by our first look at the data,” added Dr. Heinz Lubenau, General Manager of VAXIMM GmbH, a fully owned subsidiary of VAXIMM AG in Germany. “A high percentage of patients seem to react to the vaccine with a strong specific T-cell response. We could dose all patients as planned, up to the highest dose group. The vaccine was very well tolerated.”
Dr. Klaus Breiner, Executive Chairman of VAXIMM AG and Managing Partner at BB BIOTECH VENTURES, commented, “Completing enrollment in record time is a great achievement. We are enthusiastic about the clinical potential of VXM01 for the treatment of cancer patients, and about the broader utility of our novel vaccine platform to address additional cancer targets.”
