DGAP-Adhoc: 4SC AG: 4SC provides headline results from Yakult Honsha's Phase II trial of resminostat in combination with sorafenib as first line therapy in liver cancer


4SC AG  / Key word(s): Study results

27.05.2016 15:44

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
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The issuer is solely responsible for the content of this announcement.

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4SC provides headline results from Yakult Honsha's Phase II trial of
resminostat in combination with sorafenib as first line therapy in liver
cancer

Planegg-Martinsried, Germany, 27 May 2016 - 4SC AG (4SC, FSE Prime
Standard: VSC) today announced that its Japanese partner Yakult Honsha Co.,
Ltd. (Yakult Honsha) has completed the randomized Phase II part of a
clinical Phase I/II study which evaluates 4SC's epigenetic cancer compound
resminostat in combination with the cancer drug sorafenib as a potential
novel first-line therapy of Asian patients in Japan and South Korea with
advanced liver cancer (hepatocellular cancer, HCC).

In April 2011, 4SC has granted an exclusive license to Yakult Honsha, the
Japanese market leader in gastro-intestinal cancer therapeutics, for the
development and commercialization of resminostat in Japan. After
successfully completing a Phase I safety study with resminostat in Japanese
patients with advanced solid tumors in May 2014, Yakult Honsha initiated
the Phase I/II study in patients with HCC, a cancer with high medical need
and very limited therapeutic options, which has a particularly high
incidence in Japan.

In the Phase II part in 170 Asian patients with advanced HCC, resminostat
in combination with sorafenib as first-line therapy in HCC did not meet the
primary endpoint of statistically significant prolonged time to disease
progression (TTP) compared to sorafenib monotherapy. Based on the result of
the Phase II part, Yakult Honsha will not conduct a pivotal study of
resminostat/sorafenib combination as first-line treatment of HCC in all-
comer patients.

However, patients with high expression levels of the ZFP64 biomarker at
baseline seem to have longer TTP in the sorafenib/resminostat combination
therapy when compared with sorafenib monotherapy.

Yakult Honsha is now analyzing the results in more detail. Other ongoing as
well as planned clinical trials, and in particular 4SC's anticipated Phase
II CTCL trial in the EU, will not be affected.


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Information and Explanation of the Issuer to this News:

About Resminostat

Resminostat is an HDAC (histone deacetylase) inhibitor administered in
tablet form with an innovative epigenetic mechanism of action. The compound
has already been clinically tested for treating Hodgkin's lymphoma as well
as liver, lung, colon, pancreatic, and biliary tract cancer. In new
preclinical models, resminostat further showed promising anti-cancer and
immunomodulatory activity.

About liver cancer (liver cell carcinoma, hepatocellular carcinoma, HCC)

With around 748,000 new cases each year, liver cancer is the fifth most
common type of cancer worldwide and the third most frequent tumor-related
cause of death. In the past three decades alone, the number of new cases
has almost doubled. Liver cancer often remains undetected until it reaches
an advanced stage, resulting in only a slim chance of recovery. The
tyrosine kinase inhibitor sorafenib is the only approved drug-based first-
line therapy for patients with advanced liver cancer which has been shown
to offer a survival benefit in clinical trials.

About the resminostat partnering agreement with Yakult Honsha for Japan

4SC granted an exclusive license to Yakult Honsha for the development and
commercialization of resminostat in Japan in April 2011. 4SC has received
an upfront payment from Yakult Honsha of EUR 6 million and is eligible for
up to approximately EUR 127 million payable upon achieving specified
milestones including clinical and regulatory events in Japan. In addition
to milestone payments, Yakult Honsha will pay 4SC double-digit royalties
linked to product sales of resminostat. Yakult Honsha will be responsible
for all clinical requirements for resminostat development in Japan in
oncology indications.

About 4SC

4SC (www.4sc.com) is a biotechnology company dedicated to the research and
development of small-molecule drugs focused on epigenetic mechanisms of
action for the treatment of cancers with high unmet medical needs. These
drugs are intended to provide innovative treatment options for cancer
patients that are more tolerable and efficacious than existing therapies,
provide a better quality of life and offer increased life expectancy. The
Company's pipeline comprises promising products that are in various stages
of clinical development. 4SC's aim is to generate future growth and enhance
its enterprise value by entering into partnerships with pharmaceutical and
biotech companies. Founded in 1997, 4SC had 50 employees at 1 May 2016. 4SC
has been listed on the Prime Standard of the Frankfurt Stock Exchange since
December 2005.

Forward-looking information

This press release contains certain forward-looking statements. Any
forward-looking statement applies only on the date of this press release.
By their nature, forward-looking statements are subject to a number of
known and unknown risks and uncertainties that may or may not occur in the
future and as a result of which the actual results and performance may
differ substantially from the expected future results or performance
expressed or implied in the forward looking statements. No warranties or
representations are made as to the accuracy, achievement or reasonableness
of such statements, estimates or projections, and 4SC AG has no obligation
to update any such information or to correct any inaccuracies herein or
omission herefrom which may become apparent.

Contact

4SC AG
Corporate Communications & Investor Relations
Wolfgang Güssgen, wolfgang.guessgen@4sc.com, +49 89 700763-73
Dr. Anna Niedl, anna.niedl@4sc.com, +49 89 700763-66

MC Services
Katja Arnold, katja.arnold@mc-services.eu, +49 89 210228-40

The Ruth Group
Carol Ruth, cruth@theruthgroup.com, +1 646 536 7004

27.05.2016 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap.de

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Language:     English
Company:      4SC AG
              Am Klopferspitz 19a
              82152 Planegg-Martinsried
              Germany
Phone:        +49 (0)89 7007 63-0
Fax:          +49 (0)89 7007 63-29
E-mail:       public@4sc.com
Internet:     www.4sc.com
ISIN:         DE000A14KL72
WKN:          A14KL7
Listed:       Regulated Market in Frankfurt (Prime Standard); Regulated
              Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart,
              Tradegate Exchange
 
End of Announcement                             DGAP News-Service
 
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