Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners
Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners

Shares of Compugen (CGEN) surged in pre-market trading after the Israeli biotech company said that the clinical hold on its investigational new drug application for COM701 was lifted by the U.S. Food and Drug Administration.

Separately, Compugen said the FDA cleared Bayer’s (BAYRY) IND application for BAY 1905254.

CLINICAL HOLD LIFTED

Compugen said this morning that the FDA has lifted the clinical hold on its IND for COM701, an immuno-oncology therapeutic antibody targeting PVRIG in patients with advanced solid tumors.

The FDA said the company may now begin a clinical study of the antibody. PVRIG is an investigational monoclonal antibody, a molecule that has the ability to bind with high specificity to a given target, being developed by Compugen to treat various types of cancer.

“We believe the COM701 preclinical data suggest that targeting PVRIG may effectively stimulate an anti-tumor immune response in certain cancers such as breast, endometrial, ovarian and lung, and specifically in patient populations that are unresponsive to current checkpoint inhibitors,” Compugen President and Chief Executive Officer Anat Cohen-Dayag stated.

Looking ahead, Compugen said it plans to initiate a first-in-human Phase 1 study in the U.S. in patients with advanced solid tumors and for whom standard of care therapies are currently ineffective.

In April, Compugen said the FDA requested additional CMC information from the company in support of the COM701 IND application.

At the time, the FDA recommended a lower starting dose of COM701 for the trial.

BAYER IND APPLICATION CLEARANCE

Additionally this morning, Computgen said that the FDA approved Bayer’s (BAYRY) IND application for BAY 1905254, a a first-in-class immuno-oncology therapeutic antibody targeting the ILDR2 protein in patients with advanced solid tumors.

Compugen is entitled to receive a milestone payment upon the first patient dosing with BAY 1905254 in the Phase 1 clinical trial expected in 2018.

PRICE ACTION

In pre-market trading, Compugen is up 45c, or 13.6% to $3.75 per share.


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