First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

 Planegg-Martinsried, Germany, 6 February 2019 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced 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).

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.”

Related articles

30 January 2019, First patient enrolled in 3rd dose cohort of Phase Ib/II study SENSITIZE

14 January 2019, 4SC’s domatinostat (4SC-202) begins Phase II gastrointestinal cancer clinical trial

27 December 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

20 September 2018, Domatinostat plus chemotherapy – Overcoming drug resistance

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises three key drug candidates in various stages of preclinical and clinical development: resminostat, domatinostat (4SC-202) and 4SC-208.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 46 employees as of 30 September 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

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).

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.