FDA demand puts Compugen’s solid tumor checkpoint trial on ice

Compugen is yet to commit to a timeline for clearing the blockade, saying only that it is progressing “as quickly as possible.” (FDA)

The FDA has temporarily blocked Compugen’s plans to start a phase 1 trial of PVRIG-targeting cancer drug COM701. Officials caused the delay by demanding to see additional CMC information before signing off on the study.

Compugen filed its IND late last month. After reviewing the submission, the FDA recommended the use of a lower starting dose of the antibody. That means Compugen will need to use a more sensitive assay detection method. The upshot of the regulatory interaction is that the trial is on clinical hold until Compugen gets the additional information to the FDA. 

Holon, Israel-based Compugen has yet to commit to a timeline for clearing the blockade, saying only that it is “working closely” with the FDA to submit the requested information “as quickly as possible.” 

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

In parallel, Compugen is working on other aspects of its clinical preparations to ensure it can start dosing patients as soon as possible after the FDA greenlights the study. The selection of the U.S. trial sites that will enroll advanced solid tumor patients in the study is ongoing.

Getting the trial started will be a big moment for Compugen. Over the past few years, Compugen has talked up its ability to identify novel immune checkpoint targets but was understandably reticent to say much specific about its activities during their early stages.

Through its alliance with Bayer, Compugen revealed one of the targets it has identified is ILDR2, a B7/CD28-like immune checkpoint. Compugen has also started to open up about its internal targets as programs have progressed through preclinical, disclosing that its most advanced prospects are aimed at PVRIG and TIGIT. The plan is to combine anti-PVRIG and anti-TIGIT antibodies.

Compugen thinks the assets can stimulate T cell activation, thereby enhancing the immune system’s attack on tumors. But neither its internal programs nor Bayer’s BAY 1905254 have advanced into the clinic, leaving Compugen relying on preclinical evidence to support its claims. Bayer is due to move its drug into human testing this year.

When COM701 joins it in the clinic will depend on the speed of Compugen’s response to the FDA.