Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
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 2,400+ 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.


Scientific News
Toxin from Salmonid Fish has Potential to Treat Cancer
Researchers from the University of Freiburg decode molecular mechanism of fish pathogen.
New Diabetes Drug has Unexpected Side Effect
A type of drug used to treat diabetes may reduce the risk of developing Parkinson’s disease, according to new research.
Researchers Develop Vaccine that Protects Primates Against Ebola
A collaborative team from The University of Texas Medical Branch at Galveston and the National Institutes of Health have developed an inhalable vaccine that protects primates against Ebola.
Cannabis May Be Used to Treat Fractures
TAU researcher finds non-psychotropic compound in marijuana can help heal bone fissures.
A Novel Drug to FIght Malaria
An international team of scientists has announced that a new compound to fight malaria is ready for human trials.
New Cell Structure Finding Might Lead to Novel Cancer Therapies
University of Warwick scientists in the U.K. say they have discovered a cell structure which could help researchers understand why some cancers develop.
Creating More Potent Vaccines
Yale researchers uncovered a new role for a type of immune cell, known as regulatory T cells, in promoting long-term immunity.
Potential Therapeutic for Blinding Eye Disease
NIH research points to microglia as potential therapeutic target in retinitis pigmentosa.
Potential New Class of Cancer Drugs
Scientists have found a way to stop cancer cell growth by targeting the Warburg Effect, a trait of cancer cell metabolism that scientists have been eager to exploit.
Global Search for Next Antibiotic
University of Queensland researchers have launched a global search to discover antibiotics capable of combating superbug bacteria that are resistant to current antibiotics.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!