Tag: VAXIMM AG
– Study meets endpoints and demonstrates safety and tolerability of VXM01 –
VAXIMM AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced today topline data from the first clinical trial of its investigational oral cancer vaccine VXM01. The randomized, placebo-controlled, double-blind Phase I/II dose escalation study met all key endpoints and demonstrated safety and tolerability.
The study code-named VXM01-01-DE 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 vaccine targeting the tumor vasculature, or placebo.
The results of the study indicate that the vaccine was safe and well tolerated. No dose-limiting toxicities were observed. Besides this primary endpoint, several important secondary endpoints, including specific T-cell response and changes in tumor perfusion, were met. After vaccination with VXM01, a quarter of the patients showed a strongly increased T-cell mediated immune response against the target (VEGFR-2). This effect was distinct from fluctuations observed in the placebo-treated patients. Immunologically responding patients occurred already in the lowest dose group. A third of the VXM01-treated patients had a strong drop in tumor perfusion following the treatment, accompanied by corresponding changes in tumor-specific and angiogenesis-related biomarkers. Tumor perfusion changes in the treatment group were correlated with the VEGFR-2 specific effector and regulatory T-cell responses. More detailed results from the trial will be submitted for presentation at upcoming scientific meetings and for publication in a peer-reviewed journal.
“We are delighted to see that VXM01 was safe and well tolerated in the patients we treated,” said PD Dr. Hubertus Schmitz-Winnenthal, principal investigator of the study. “We are especially excited about the encouraging data observed in the two key secondary endpoints. The vaccine seems to be able to induce and enhance the VEGFR-2 specific T-cell response and to impact tumor perfusion in a good proportion of treated patients.”
“We are very encouraged by these data,” added Dr. Heinz Lubenau, General Manager of VAXIMM GmbH, a fully owned subsidiary of VAXIMM AG in Germany. “It provides a strong basis for continuing the development of VXM01 for the treatment of solid tumor diseases. Following regulatory approval, we plan to re-open the study VXM01-01-DE for further recruitment of pancreatic cancer patients.”
Dr. Klaus Breiner, Executive Chairman of VAXIMM AG commented: “We are very pleased with this outcome. This first-in-man study was already designed as a placebo-controlled trial, providing us with a high level of confidence in the validity of the results.”
VAXIMM AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced today 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 which is administered orally and which acts in the gut to induce an anti-tumor response of the immune system.
VAXIMM AG, a Swiss-German biotech company focusing on cancer vaccines, today announced that its German subsidiary VAXIMM GmbH has been awarded a grant from the leading-edge BioRN cluster “Cell-based and Molecular Medicine” to expand its oral T-cell vaccine technology platform. The cluster competition is a program of Germany´s Federal Ministry of Education and Research (BMBF) to promote top-notch innovation in Germany.
VAXIMM’s lead candidate VXM01 is an oral T-cell vaccine, which targets the tumor vasculature. It is currently in Phase I/II clinical evaluation in pancreatic cancer patients at the Heidelberg University Hospital. The funding from the leading-edge cluster program will be used to develop additional cancer vaccines complementary to VXM01, which are based on the same oral T-cell vaccine technology. A second candidate (VXM06), which targets an undisclosed, abundant, tumor-specific antigen, is already in preclinical development. Two further product candidates are at discovery stage.
VAXIMM’s oral T-cell vaccine technology has a number of advantages. The platform can easily and rapidly generate new vaccines, including multivalent vaccines. The resulting products combine oral efficacy with safety and excellent tolerability. Moreover, the vaccines do not require a complex manufacturing infrastructure.
VAXIMM AG, a Swiss-German biotech spin-off from Merck KGaA focusing on cancer vaccines, announced today the appointment of Jean-Paul Prieels as a new member of its Board of Directors.
Dr. Prieels is a renowned industry expert in the vaccine field. He held various executive positions at GlaxoSmithKline, where he headed the vaccine research and development in Rixensart, Belgium, among others. Dr. Prieels, who joined GlaxoSmithKline Biologicals (formerly SmithKline Beecham Biologicals) in 1987, has been instrumental in developing several marketed vaccines, including cervical cancer vaccine Cervarix™, Rotarix™ to protect from rotavirus infection, and Synflorix™ for the prevention of pneumococcal infections. He retired from GSK as Senior Vice President Research and Development in early 2011 and is currently a board member of several biotech companies in the vaccine field.
VAXIMM’s lead product candidate VXM01 is being evaluated in a placebo-controlled phase I dose escalation study enrolling up to 45 pancreatic cancer patients, with results expected in H1, 2013.