PHILADELPHIA and TORONTO Arius Research and Avid Bioservices have entered into a manufacturing supply and technology transfer agreement involving Arius’ lead cancer stem cell antibody candidate, CD44. The anticancer antibody targets a novel epitope of CD44 found in breast, colon, and prostate cancers.
The drug has yet to be approved by the Food and Drug Administration. A pre-investigational new drug meeting is scheduled for January. Avid has begun manufacturing the drug for human clinical trials, which it expects to begin next year.
“The initiation of manufacturing and the scheduling of our pre-IND meeting with the FDA in January reflect the significant progress we have made with our CD44 cancer stem cell program,” Arius chief executive and president Dr. David Young said in a statement.
He added that, “Avid has proven expertise in the scale-up and manufacture of clinical and commercial grade antibodies and will provide us with a supply of our CD44 targeting drug to initiate human clinical trials in 2008, subject to the clearance of our IND by the FDA.”