DGAP-News: 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

• Safety Review Committee examined data from the first dose cohort and recommends EMERGE to continue with a second dose cohort
• Patient recruitment for the second dose cohort has initiated

Planegg-Martinsried, Germany, 25 July 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced, 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). 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).

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."

- Press release ends -

Related articles

11 July 2019, Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, Domatinostat's mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

Further information

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 two drug candidates in clinical development: resminostat and domatinostat.

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 47 employees as of 31 March 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About domatinostat

Domatinostat is an orally administered small molecule class I selective HDAC inhibitor. It strengthens the body's own anti-tumor immune response, influences the tumor and tumor microenvironment, making the tumor more visible to the immune system and facilitates the infiltration of immune cells into the tumor.

Domatinostat has been investigated in a Phase I study in 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 or relapsed 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.

Contact

4SC
Anna Niedl, Ph.D., CIRO
Corporate Communications & Investor Relations
anna.niedl@4sc.com
+49 89 700763-66