On July 25, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee consisting of clinical and drug safety experts evaluated the safety data from the first dose cohort and recommended continuation with the second dose cohort in the ongoing Phase Ib/II EMERGE study (ClinicalTrials.gov identifier: NCT03812796) (Press release, 4SC, JUL 25, 2019, View Source [SID1234537749]). Patient recruitment for the second dose cohort has been initiated. The study is being 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).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The multi-center, single-arm, open-label study initiated in January 2019, is a dose escalation study, conducted initially in up to 15 patients with microsatellite-stable gastrointestinal cancer. The study evaluates domatinostat in combination with the checkpoint inhibitor avelumab. The study is conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with a checkpoint inhibitor and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose.
Prof. Cunningham said: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review and are looking forward to enrolling patients into the second dose cohort, especially as checkpoint inhibitors alone so far have not shown clinical activity in patients with microsatellite-stable gastrointestinal cancer."
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, such as the SENSITIZE trial of domatinostat in combination with pembrolizumab, another checkpoint inhibitor, in patients with advanced-stage melanoma.
We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."