On January 14, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the first clinical centers of the investigator-sponsored Phase II study EMERGE are open for patient recruitment (Press release, 4SC, JAN 14, 2019, View Source [SID1234532636]). The study is conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).
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The multi-center, single-arm, open-label study examines domatinostat (formerly 4SC-202) plus checkpoint inhibitor avelumab in up to 70 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.
Prof. Cunningham said: "Although checkpoint inhibitors are very successful in various solid tumor indications, MSS-GI cancer has proven to be largely therapy-resistant to these. The EMERGE study will seek to address this high medical need by using domatinostat to render the tumor tissue susceptible to avelumab. We need to study more drug candidates like domatinostat, which aim to broaden the efficacy of checkpoint inhibitors when used in combination."
Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies. We are very proud that Prof. Cunningham, a widely respected expert in the field, chose to perform the EMERGE study with domatinostat and we are looking forward to the outcome."
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About domatinostat (4SC-202)
Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.
Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).
In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).
As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel-cell carcinoma (MCC).