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PRESS RELEASE: 4SC AG: First Patient Enrolled in DONIMI Study Evaluating Domatinostat in the Neoadjuvant Setting in Melanoma

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DGAP-News: 4SC AG / Key word(s): Study
4SC AG: First Patient Enrolled in DONIMI Study Evaluating Domatinostat in
the Neoadjuvant Setting in Melanoma

2020-01-15 / 07:30
The issuer is solely responsible for the content of this announcement.

*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 (https://melanoma-inc.org [1] ).

*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."

_- Press release ends -_

*Related articles*

16 October 2019, 4SC and Netherlands Cancer Institute Collaborate on
Clinical Evaluation of Domatinostat in the Neoadjuvant Setting in Melanoma
[2]

14 January 2019, 4SC's domatinostat (4SC-202) begins Phase II
gastrointestinal cancer clinical trial [3]

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

20 September 2018, Domatinostat plus chemotherapy - Overcoming drug
resistance [5]

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in
melanoma [6]

*Further information*

*About 4SC*

4SC AG [7] 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 [8] and domatinostat [9].

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*

Domatinostat [9] 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.

*Contact*

ir-pr@4sc.com
+49 89 700763-0

2020-01-15 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: 4SC AG
Fraunhoferstr. 22
82152 Planegg-Martinsried
Germany
Phone: +49 89 700763-0
Fax: +49 89 700763-29
E-mail: ir-pr@4sc.com
Internet: www.4sc.com
ISIN: DE000A14KL72
WKN: A14KL7
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
EQS News ID: 953183

End of News DGAP News Service

953183 2020-01-15


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(MORE TO FOLLOW) Dow Jones Newswires

January 15, 2020 01:30 ET ( 06:30 GMT)
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