CARsgen nabs orphan drug designation for anti-claudin18.2 CAR T therapy

By The Science Advisory Board staff writers

October 5, 2020 -- CARsgen Therapeutics has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for CT041, a humanized anti-claudin18.2 autologous chimeric antigen receptor (CAR) T-cell product, targeting claudin18.2-positive cancers.

CT041 is the first claudin18.2-targeted CAR T-cell therapy to receive investigational new drug (IND) clearance by the FDA and the National Medical Products Administration (NMPA) in China. The therapy is currently being investigated in an open-label, multicenter phase IB clinical trial in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma.


Copyright © 2020 scienceboard.net
 


Email Address:

First Name:

Last Name:

Learn about ScienceBoard

Get the latest life sciences research and industry news, delivered straight to your inbox, for free.

Why subscribe?

ScienceBoard is uniquely focused on the business of research, addressing the biggest problems that the biomedical industry face. You’ll get breaking news, events coverage, and deep dives into the science that drives innovation, delivered to your inbox daily.

I have read and agree to the privacy policy and terms of service and wish to opt-in for ScienceBoard.net.