First Patient Enrolled in DONIMI Study Evaluating Domatinostat in the Neoadjuvant Setting in Melanoma

Planegg-Martinsried, Germany, 15 January 2020 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced that the Netherlands Cancer Institute in Amsterdam has enrolled the first patient in DONIMI - a multicenter, investigator-sponsored phase 1b study, testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage III melanoma in the neoadjuvant setting.

Immunotherapy, and particularly checkpoint inhibitors like anti-PD-1 (e.g. Nivolumab) and anti-CTLA4 (Ipilimumab), are increasingly investigated not only in the advanced unresectable or metastatic setting but also in earlier stages of disease. The rationale for such treatment is to activate the immune system before resection of the tumor to generate an immune memory. The study is conducted by Prof. Christian Blank, MD, Staff Member at the Department of Medical Oncology, and Group Leader at the Division of Immunology, The Netherlands Cancer Institute, Amsterdam. A second site will be opened soon at the University of Sydney, Australia, with the support of Prof. Georgina Long, MD, Co-Medical Director of Melanoma Institute Australia. NKI_AVL and University of Sydney are part of the International Neoadjuvant Melanoma Consortium ( ).

Jason Loveridge, Ph.D., CEO of 4SC: "Such a very rapid start to DONIMI signals a high level of interest in both the neoadjuvant setting as well as the combination of domatinostat and checkpoint blockade in this population and we look forward to further patients enrolling in 2020."

Prof. Dr. Christian Blank, NKI: "We are delighted having enrolled the first patient into the DONIMI study - after less than one year's preparation, this is an extraordinary achievement. As the major oncology conferences in 2019 have clearly highlighted neoadjuvant immunotherapy as one of the most interesting areas of clinical research, we are excited to investigate domatinostat in combination with checkpoint inhibitor in the neoadjuvant setting in melanoma."

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Further information

About 4SC

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: and .

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 30 September 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About The Netherlands Cancer Institute

The Netherlands Cancer Institute (NKI), including the Antoni van Leeuwenhoek Hospital, is the only dedicated Comprehensive Cancer Centre in the Netherlands and has been at the international forefront of cancer care and research for more than a century. In 2017, the European Academy of Cancer Sciences designated the NKI a Comprehensive Cancer Centre of Excellence for translational research. The NKI maintains an important role as a national and international centre of scientific and clinical expertise, development and training. Research focus areas are molecular biology, immunotherapy, personalized medicine, image-guided interventions and cancer survivorship.

Nowadays, The Netherlands Cancer Institute accommodates approximately 650 scientists and scientific support personnel. The Antoni van Leeuwenhoek Hospital has 222 medical specialists, 212 beds, an out-patients clinic with around 134,000 visits, 12 operating theatres and 12 irradiation units for radiotherapy.

About 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 (SENSITIZE) and data from the first part of the study was presented at ESMO in Barcelona. 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 being conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust, London, UK (EMERGE).

About neoadjuvant treatment

Neoadjuvant treatment is given as a first treatment step in patients with locally advanced tumors to shrink the tumor before the main treatment, which is usually surgery, is given. Surgical treatment carries the risks of morbidities and potential complications that could be lasting. In addition, patients with locally advanced tumors, i.e. patients with resectable stage III melanoma continue to have a high risk of relapse and death despite the use of standard adjuvant therapy. Neoadjuvant therapy has the potential to significantly improve the clinical outcome of these patients, particularly in the era of newer and effective targeted and immunotherapeutic agents.

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.

 

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