Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Xetra  >  4SC AG    VSC   DE000A14KL72

4SC AG

(VSC)
  Report
SummaryQuotesChartsNewsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector newsAnalyst Recommendations

4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

share with twitter share with LinkedIn share with facebook
share via e-mail
0
12/13/2019 | 01:45am EST

DGAP-News: 4SC AG / Key word(s): Study
4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer
13.12.2019 / 07:30
The issuer is solely responsible for the content of this announcement.


4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

  • Safety Review Committee examined data from the second dose cohort and recommends EMERGE to continue with the third and final dose cohort
  • Patient recruitment for the third dose cohort will start in January 2020

Planegg-Martinsried, Germany, 13 December 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Safety Review Committee consisting of clinical and drug safety experts evaluated the safety data from the second dose cohort and recommended continuation with the third and final dose cohort in the ongoing Phase Ib/II EMERGE study (ClinicalTrials.gov identifier: NCT03812796). Patient recruitment for the third dose cohort will begin in January 2020. The study is being conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

The multi-center, single-arm, open-label study initiated in January 2019, is a dose escalation study in the first part, conducted initially in up to 15 patients with microsatellite-stable gastrointestinal cancer. The study evaluates domatinostat in combination with the checkpoint inhibitor avelumab. The study is conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with a checkpoint inhibitor and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose.

- Press release ends -

 

Related articles

25 July 2019, 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

11 July 2019, Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, Domatinostat's mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer


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 two drug candidates in clinical development: resminostat and domatinostat.

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 domatinostat

Domatinostat is an orally administered small molecule class I selective HDAC inhibitor. It strengthens the body's own anti-tumor immune response, influences the tumor and tumor microenvironment, making the tumor more visible to the immune system and facilitating the infiltration of immune cells into the tumor.

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. 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 from which initial data was presented at ESMO 2019. 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.

4SC also plans to advance domatinostat into a number of other studies in combination with a checkpoint inhibitor, including in patients with advanced Merkel-cell carcinoma (MCC), in 2019 and 2020.

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



13.12.2019 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


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: 934657

 
End of News DGAP News Service

934657  13.12.2019 

fncls.ssp?fn=show_t_gif&application_id=934657&application_name=news&site_id=zonebourse

© EQS 2019
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on 4SC AG
01/154SC AG : First Patient Enrolled in DONIMI Study Evaluating Domatinostat in the N..
EQ
01/094SC AG : 3 upcoming conferences
EQ
01/074SC : enters into avelumab supply agreement with Merck KGaA, Darmstadt, Germany ..
EQ
20194SC AG : Release according to Article 40, Section 1 of the WpHG [the German Secu..
EQ
20194SC AG : Preliminary announcement of the publication of quarterly reports and qu..
EQ
20194SC AG : Preliminary announcement of the publication of financial reports accord..
EQ
20194SC AG : Positive safety review of Phase Ib/II EMERGE study of domatinostat + av..
EQ
20194SC AG : Correction of a release from 19/11/2019 according to Article 40, Sectio..
EQ
20194SC AG : Release according to Article 40, Section 1 of the WpHG [the German Secu..
EQ
20194SC AG : Release according to Article 41 of the WpHG [the German Securities Trad..
EQ
More news
Financials (EUR)
Sales 2019 -
EBIT 2019 -
Net income 2019 -
Debt 2019 -
Yield 2019 -
P/E ratio 2019 -
P/E ratio 2020 -
Capi. / Sales2019 -
Capi. / Sales2020 -
Capitalization 112 M
Chart 4SC AG
Duration : Period :
4SC AG Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends 4SC AG
Short TermMid-TermLong Term
TrendsBullishBullishBearish
Income Statement Evolution
Consensus
 
Mean consensus -
Number of Analysts
Average target price
Last Close Price 2,43  
Spread / Highest target -
Spread / Average Target -
Spread / Lowest Target -
EPS Revisions
Managers
NameTitle
Jason Loveridge Chief Executive Officer
Clemens M. Doppler Chairman-Supervisory Board
Susanne Danhauser-Riedl Chief Medical Officer
Manfred Rüdiger Member-Supervisory Board
Helmut Jeggle Member-Supervisory Board
Sector and Competitors
1st jan.Capitalization (M$)
4SC AG15.17%124
IQVIA HOLDINGS INC.4.53%31 339
LONZA GROUP3.40%28 010
CELLTRION, INC.--.--%20 141
SEATTLE GENETICS, INC.-4.60%18 681
INCYTE CORPORATION-7.81%17 339