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

• Safety Review Committee (SRC) examined data from second dose cohort
• SRC recommends SENSITIZE to continue with third dose cohort

Planegg-Martinsried, Germany, 27 December 2018 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the second dose cohort and recommended continuation with the third dose cohort in the ongoing Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665).

The SENSITIZE study is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors). In the first part of the study, three patient cohorts will be treated at three different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first dose-finding part of the study. 4SC anticipates top-line data to be available around the middle of 2019.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: “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 earlier this year and the recent second one and are looking forward to enrolling patients into the third dose cohort. By continuing with the SENSITIZE study and the soon to be initiated investigator-sponsored EMERGE study of domatinostat in combination with the checkpoint inhibitor avelumab in patients with gastrointestinal cancer, we will continue to execute on our clinical development plan for domatinostat, which is intended to lead to the initiation of a potentially pivotal trial in H2 2019.”

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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.