Basel (Switzerland), Mannheim (Germany), October 22nd, 2012 – 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.
“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 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.”
About VAXIMM:
VAXIMM is a privately held, Swiss-German biotech company that is primarily focused on developing
active immunotherapies (vaccines) for patients suffering from cancer. Its initial product candidate
VXM01 is targeting the tumor vasculature, which is essential for tumors to grow beyond microscopic
size. VXM01 has shown impressive anti-tumor activity in various animal studies and commenced
human clinical trials in 2011. In addition to VXM01, VAXIMM is developing a pipeline of
complementary immunotherapies. VAXIMM was formed in 2008 as a joint venture of BB Biotech
Ventures and Merck KGaA. Merck Serono Ventures, Sunstone Capital and BioMedPartners joined as
investors in 2010. VAXIMM GmbH is a fully owned subsidiary of VAXIMM AG, with offices in
Mannheim, Germany. For more information, please see www.vaximm.com.
About VXM01:
VXM01 is an oral T-cell vaccine that targets the tumor vasculature. VXM01 uses VAXIMM’s
proprietary oral T-cell vaccination platform technology and carries vascular endothelium growth
factor receptor-2 (VEGFR-2) as target gene. An analog vaccine has shown very impressive anti-tumor
activity in different tumor types in numerous animal studies. This activity was linked to a VEGFR-2
specific T-cell response and correlated with the destruction of the tumor vasculature. In animals, the
vaccine appeared to be safe and well tolerated. The original work that led to VXM01 was conducted
at The Scripps Research Institute. VXM01 is currently in clinical phase I/II development as a
treatment for solid cancer types. The profile of VXM01 makes it an ideal combination partner for
various established cancer treatments.
About Study VXM01-01-DE
The first clinical study of VXM01 is including 45 patients with inoperable pancreatic cancer and is
primarily testing the safety and tolerability of the oral, VEGFR-2 directed T-cell vaccine. Secondary
endpoints of the trial include immunological response, effects on tumor perfusion and other
angiogenesis-related biomarkers, clinical responses (RECIST) and overall survival. VXM01-01-DE has
been designed as a randomized, double-blind, placebo-controlled dose escalation study. Each of the
five dose groups consists of six patients receiving VXM01 and three patients receiving placebo, in
addition to gemcitabine as standard of care. Patients are treated with four vaccinations, which are
administered during the first seven days. In a recently approved protocol amendment, monthly
booster vaccinations have been included into the study.
Contact:
Dr. Heinz Lubenau
Tel.: +49 621 8359 687 10
Email: info@vaximm.com
Media Inquiries:
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
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Tel. +49 30 23 63 27 68