Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Ganymed’s IMAB362 Receives Orphan Drug Designation from FDA and EMA

Published: Monday, October 21, 2013
Last Updated: Monday, October 21, 2013
Bookmark and Share
IMAB362 receives orphan drug designation for the treatment of pancreatic cancer.

Ganymed Pharmaceuticals AG has announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted orphan drug designation to IMAB362 for the treatment of pancreatic cancer.

IMAB362 is a monoclonal antibody currently in Phase IIb clinical trial for gastroesophageal cancer.

“The granting of this orphan drug designation represents another important milestone for our IMAB362 program”, commented Dr. Özlem Türeci, CEO of Ganymed Pharmaceuticals.

Dr. Türeci continued, “There are presently very few therapeutic options for patients suffering from pancreatic cancer. We are excited by the promise that IMAB362 showed in preclinical models of pancreatic cancer and look forward to assessing its therapeutic potential in future clinical trials for this indication.”

Orphan drug designation is given to investigational new drugs that are under development for the treatment of life-threatening or very serious diseases that affect fewer than 200,000 patients in the US or less than 5 in 10,000 individuals across Europe.

The designation aims to promote the development of innovative drugs for patients with these rare diseases by incentivizing companies with certain benefits such as market exclusivity, tax incentives and waiving of certain regulatory and marketing fees.

IMAB362 is a first-in-class monoclonal antibody selectively binding to the tight junction protein CLDN18.2 which is expressed in approximately 60% of primary and metastatic pancreatic cancers.

CLDN18.2 is also expressed in up to 80% of gastroesophageal cancers as well as in other solid tumors. However, CLDN18.2 is absent from the vast majority of healthy tissues.

This makes IMAB362 cancer cell selective with little or no effect on healthy cells and reduced risks of side effects. This represents a great advantage over other anticancer therapies which target both cancerous and healthy cells.


Further Information
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 2,500+ scientific posters on ePosters
  • More Than 3,700+ 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.

Related Content

Ganymed’s IMAB027 Enters Phase I/II Clinical Trial for Ovarian Cancer
Second antibody from Ganymed’s ideal monoclonal antibody platform in the clinic.
Thursday, February 13, 2014
Ganymed Pharmaceuticals to Present at the 32nd Annual J.P. Morgan Healthcare Conference
Conference will take place from January 13 to January 16, 2014 in San Francisco.
Thursday, December 26, 2013
Ganymed Pharmaceuticals Closes EUR 45 Million Financing Round
Company to accelerate clinical development of antibodies IMAB362 and IMAB027 for the treatment of cancer.
Monday, November 18, 2013
Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
Investigating the Vape
Expert independent review concludes that e-cigarettes have potential to help smokers quit.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Researchers Discover Synthesis of a New Nanomaterial
Interdisciplinary team creates biocomposite for first time using physiological conditions.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
Marijuana Genome Unraveled
A study by Canadian researchers is providing a clearer picture of the evolutionary history and genetic organization of cannabis, a step that could have agricultural, medical and legal implications for this valuable crop.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!