FDA puts Compugen trial on hold pending CMC info

Apr 30, 2018

The FDA has put a temporary hold on Compugen’s phase 1 trial of PVRIG-targeting cancer drug, COM701, requesting that the drugmaker provide additional CMC information.

Israel-based Compugen initially submitted its IND application in late March for its first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose.

Compugen’s IND application review can be completed and the application can be taken off clinical hold once the requested information is provided to the FDA.

Preclinical data for COM701 suggests that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments.

Read the press release

 

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