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

Published: Monday, October 21, 2013
Last Updated: Monday, October 21, 2013
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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.


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