DGAP-News: 4SC AG: First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

Nachricht vom 06.02.201906.02.2019 (www.4investors.de) -

DGAP-News: 4SC AG / Key word(s): Study

4SC AG: First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer
06.02.2019 / 07:30

The issuer is solely responsible for the content of this announcement.
First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

Planegg-Martinsried, Germany, 6 February 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced the enrollment of the first patient in the investigator-sponsored Phase II study EMERGE (ClinicalTrials.gov identifier: NCT03812796), conducted by Prof. David Cunningham from The Royal Marsden NHS Foundation Trust (London, UK).

The multi-center, single-arm, open-label study examines domatinostat plus checkpoint inhibitor avelumab in up to 75 patients with advanced gastrointestinal cancer - precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Jason Loveridge, Ph.D., CEO of 4SC: "Enrolling the first patient in the EMERGE study is a significant milestone for 4SC. We thank Prof. Cunningham and his team as well as the involved clinical centers for their enthusiasm in conducting this important study.

We are convinced that the combination of domatinostat with checkpoint inhibitors is the best route to most rapidly progress domatinostat towards market approval. In parallel to the EMERGE study, we are evaluating domatinostat in combination with another checkpoint inhibitor (pembrolizumab) in melanoma patients in the SENSITIZE study.

We will continue to execute on our clinical development plan, which is intended to lead to the initiation of a potentially pivotal trial in 2019."

- Press release ends -


Related articles

30 January 2019, First patient enrolled in 3rd dose cohort of Phase Ib/II study SENSITIZE

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

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

20 September 2018, Domatinostat plus chemotherapy - Overcoming drug resistance

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 three key drug candidates in various stages of preclinical and clinical development: resminostat, domatinostat (4SC-202) and 4SC-208.

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 46 employees as of 30 September 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About domatinostat (4SC-202)

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. 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 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.



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

LifeSci Advisors
Hans Herklots
Managing Directorhherklots@lifesciadvisors.com
+41 79 598 7149

06.02.2019 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


Fraunhoferstr. 22

82152 Planegg-Martinsried

+49 89 700763-0
+49 89 700763-29
Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange

End of News
DGAP News Service

772727  06.02.2019 

Aktuelle Nachrichten aus der 4investors-Redaktion

21.02.2019 - Mologen Aktie: Kommt nun die zweite Welle von Gewinnmitnahmen?
21.02.2019 - Wirecard Aktie: Kommt noch ein Absturz?
21.02.2019 - Dermapharm bringt neue Heuschnupfen-Arzneien auf den Markt
21.02.2019 - RIB Software übernimmt Mehrheit an Levtech
21.02.2019 - Datron hält Dividende konstant - Gewinnanstieg erwartet
21.02.2019 - Datagroup: „Auftragseingang in den vergangenen Monaten war sensationell”
21.02.2019 - Siltronic Aktie stürzt ab - Ausblick verschreckt die Börse
21.02.2019 - Deutsche Telekom hebt Dividende an: In den USA läuft es
21.02.2019 - Henkel erhöht die Dividende - Gewinnrückgang erwartet
21.02.2019 - Nordex: Börse hakt Gewinneinbruch schnell ab - Kaufsignal!


21.02.2019 - Mologen Aktie: Kommt nun die zweite Welle von Gewinnmitnahmen?
21.02.2019 - Wirecard Aktie: Kommt noch ein Absturz?
21.02.2019 - Geely Aktie: Ein Grund zur Sorge
21.02.2019 - Nel Aktie: Gehen die Bullen jetzt hart ins Risiko?
21.02.2019 - Deutsche Bank Aktie: Was jetzt wichtig ist…
21.02.2019 - Steinhoff Aktie: Noch mehr Stress mit Aktionären?
20.02.2019 - Mologen Aktie: Ist die Kursparty gleich vorbei?
20.02.2019 - Commerzbank Aktie: Ein positives Zeichen, aber…
20.02.2019 - Nel Aktie: Die Absturzgefahren werden nicht kleiner
20.02.2019 - TUI Aktie: Schwierigkeiten beim Comebackversuch


21.02.2019 - Deutsche Telekom: Prognose für 2020 steigt an
21.02.2019 - Glencore: Komplizierte Gemengelage
21.02.2019 - Henkel: Investitionen drücken Marge
21.02.2019 - Fresenius Medical Care: Gewinnerwartungen steigen an
21.02.2019 - Aixtron Aktie: Das belastet den Aktienkurs
20.02.2019 - ElringKlinger Aktie: Die Quittung für den Dividenden-Ausfall
20.02.2019 - Fresenius kommt an der Börse gut an - Kaufempfehlungen
20.02.2019 - Telefonica Deutschland: Erste Reaktionen auf die Zahlen für 2018
20.02.2019 - Deutsche Telekom Aktie: Wird das noch was?
19.02.2019 - Mensch und Maschine: Kaufempfehlung für die Aktie


21.02.2019 - Adidas Aktie: Gelingt der Befreiungsschlag? - UBS Kolumne
21.02.2019 - DAX: Die Bullen sind am Drücker - UBS Kolumne
21.02.2019 - Nikkei 225-Index gewinnt seit Jahresbeginn rund 7 Prozent - Commerzbank Kolumne
21.02.2019 - DAX: Fokus auf 11.570 - bis dahin ist es aber noch ein gutes Stück - Donner & Reuschel Kolumne
20.02.2019 - Trend läuft weiter gegen den Euro - Donner & Reuschel Kolumne
20.02.2019 - DAX: Bekommen die Käufer nun kalte Füße? - UBS Kolumne
20.02.2019 - EuroStoxx 50: Markante Widerstandszone voraus - UBS Kolumne
20.02.2019 - Nachlassende Nachfragedynamik belastet Rohstoffpreise, langfristig Angebotslücke? - Commerzbank Kolumne
20.02.2019 - DAX lächelt freundlich, Bodenbildung aber keine Euphorie - Donner & Reuschel Kolumne
19.02.2019 - Deutschland: ZEW-Konjunkturerwartungen für den Februar - VP Bank Kolumne

All Right Reserved by minimalthemes - ©2018 Stoffels & Barck GbR