On February 6, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the enrollment of the first patient in the investigator-sponsored Phase II study EMERGE (ClinicalTrials.gov identifier: NCT03812796), conducted by Prof. David Cunningham from The Royal Marsden NHS Foundation Trust (London, UK) (Press release, 4SC, FEB 6, 2019, View Source [SID1234533092]).

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The multi-center, single-arm, open-label study examines domatinostat plus checkpoint inhibitor avelumab in up to 75 patients with advanced gastrointestinal cancer – precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Jason Loveridge, Ph.D., CEO of 4SC: "Enrolling the first patient in the EMERGE study is a significant milestone for 4SC. We thank Prof. Cunningham and his team as well as the involved clinical centers for their enthusiasm in conducting this important study.

We are convinced that the combination of domatinostat with checkpoint inhibitors is the best route to most rapidly progress domatinostat towards market approval. In parallel to the EMERGE study, we are evaluating domatinostat in combination with another checkpoint inhibitor (pembrolizumab) in melanoma patients in the SENSITIZE study.

We will continue to execute on our clinical development plan, which is intended to lead to the initiation of a potentially pivotal trial in 2019."