Compugen Reports on Status of Investigational New Drug Application f
or COM701, a First-in-Class Immuno-Oncology Therapeutic Antibody

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525792]). COM701 is a 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. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest 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."

The Company will continue to provide updates on this matter as appropriate.