Tag: Merck KGaA

Company News: VAXIMM Completes Enrollment of First Oral Cancer Vaccine Trial

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.

Company News: VAXIMM Receives Grant to Expand Pipeline of Oral Cancer Vaccines

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.

Company News: Jean-Paul Prieels joins VAXIMM’s Board of Directors

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.

Food for Thought: Simply Obscene

In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”.  The only exception according to the authors of the article was Novartis’ Gleevec.

This week, the Competence Network Malignant Lymphomas published an open “letter to the editor”  (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.

The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.

The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.