4SC AG: 4SC – Clinical Study Presentations at the ESMO congress 2021

4SC AG (4SC, FSE Prime Standard: VSC) today announced that presentations on clinical studies combining domatinostat and immune checkpoint inhibitor therapy will be presented at the European Society of Medical Oncology (ESMO) Congress being held on 16 – 21 Sep 2021. The posters will be available on 4SC’s website (https://www.4sc.com) after the presentation.

A summary of the key clinical study updates and presentations is listed below:

* Trial in progress e-poster about MERKLIN1 (1090TiP) – A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel cell carcinoma – the MERKLIN 1 study.

* E-poster about phase IIa clinical data of the investigator-sponsored trial EMERGE (443P) – A phase II trial assessing the efficacy of domatinostat plus avelumab in patients with previously treated advanced mismatch repair proficient oesophagogastric and colorectal cancers

* Oral Poster Presentation about phase Ib clinical data of the investigator-sponsored trial DONIMI (LBA39; presented by C. Blank, Amsterdam, the Netherlands on Monday September 20th, 5:50 – 5:55pm CEST) – Personalized combinations of neoadjuvant domatinostat, nivolumab and ipilimumab in macroscopic stage III melanoma based on the IFN-gamma signature

* E-poster about preliminary clinical data of the investigator-sponsored trial DONIMI (#1085P) – Health related quality of life in melanoma patients treated with neoadjuvant nivolumab and domatinostat: preliminary results

About domatinostat

Domatinostat (https://www.4sc.com/product-pipeline/4sc-202/) is an orally administered small molecule class I selective HDAC inhibitor. It strengthens the body’s own anti-tumor immune response. Domatinostat modulates the tumor and tumor microenvironment making it more visible to the immune system, susceptible to concomitant checkpoint inhibition, and facilitating the infiltration of immune cells into the tumor (Bretz et al., 2019). 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 (Tresckow et al., 2019). Signs of single-agent anti-tumor efficacy were observed; with one complete remission and one partial responder. Besides its therapeutic potential as monotherapy, 4SC is focusing its development activities for domatinostat on 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 from which initial data was presented at ESMO 2019 (Hassel et al., abstract #5545) and at ASCO 2021 (Hassel et al., abstract #9545).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 currently being conducted by Prof. David Cunningham at The Royal Marsden NHS Foundation Trust in London, UK. In addition, in a collaboration with the Netherlands Cancer Institute in Amsterdam, the DONIMI Study, a multicenter, investigator-sponsored phase Ib study, is conducted testing the combination of domatinostat, nivolumab and ipilimumab in high risk stage III melanoma in the neoadjuvant setting. To advance this development program, 4SC has also signed a drug supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. for avelumab (anti-PD-L1 antibody) to conduct two Phase II clinical trials of domatinostat in combination with avelumab in advanced-stage Merkel cell carcinoma (MCC) patients progressing on previous anti-PD-(L)1 monotherapy (MERKLIN 2) and in metastatic treatment-naïve patients (MERKLIN 1).

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.