Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

VAXIMM Reports Positive Topline Data from First Oral Cancer Vaccine Trial

Published: Monday, February 18, 2013
Last Updated: Monday, February 18, 2013
Bookmark and Share
Study meets endpoints and demonstrates safety and tolerability of VXM01.

VAXIMM AG announced 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.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Making It Personal
Cancer vaccine linked to increased immune response against leukemia cells.
Improved Stability, Shelf Life of Protein Drugs
Study improves protein drug stability and extend their shelf life by tested a novel route for non-covalent protein modification.
More Effective Strategy for Producing Flu Vaccines
Researchers have developed a virus backbone, allowing producers to grow vaccine viruses in mammalian cells, rather than in eggs.
Improving Drug Production with Computer Model
A model has been developed that can be used to improve and accelerate the production of biotherapeutics, cancer drugs, and vaccines.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Vaccination Against UTIs
Researchers have successfully vaccinated mice against E.coli growth in the bladder and kidneys.
First Steps to Neutralising Zika
Researchers have discovered a highly potent antibody that neutralises Zika infection at a cellular level.
Human Astrovirus Structure Could Lead to Therapies, Vaccines
Study shows where neutralizing antibody binds to human astrovirus, a leading cause of viral diarrhoea in children, elderly, and the immune-compromised.
Fighting Off HIV Infection Closer to Reality
Researchers have made significant progress in the development of a potential vaccine to protect against HIV infection.
Powerful New Tools to Combat Zika
Researchers have created a way to replicate the stucture of Zika virus, removing the genes that make the virus infectious.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!