DGAP-News: 4SC AG: Phase II study of 4SC's resminostat in biliary tract cancer in Japan is initiated

Phase II study of 4SC's resminostat in biliary tract cancer in Japan is initiated

Final results are expected to be available by mid-2020.

Planegg-Martinsried, Germany, 19 April 2018 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that a Phase II study of 4SC's resminostat in combination with S-1 chemotherapy in biliary tract cancer in Japan was initiated by Yakult Honsha Co., Ltd. (Yakult Honsha), 4SC's development partner for resminostat in Japan. The promising results of the previous Phase I study were presented at the ESMO Congress in September 2017.

The Phase II study is conducted as a randomized, double-blind, placebo-controlled, multi-center study evaluating the combination of resminostat and S-1 chemotherapy versus S-1 chemotherapy plus placebo as second-line treatment in 100 Japanese patients with unresectable or recurrent biliary tract cancer. S-1 is a chemotherapy combination drug which is approved for the treatment of several solid tumor types including biliary tract cancer in Asia. The main goal of the study is to prolong progression free survival (PFS) and secondary objectives include efficacy and safety parameters. Final results are expected to be available by mid-2020.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "We very much appreciate the enthusiasm of our Japanese partner in the development of resminostat. Just recently Yakult Honsha joined our pivotal RESMAIN study of resminostat in cutaneous T-cell lymphoma and now they are progressing the further development of resminostat in biliary tract cancer. We look forward to hopefully being able to offer new and effective treatment options to patients and physicians in Japan."
 

- Press release ends -

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27 March 2018, Yakult Honsha joins 4SC's pivotal RESMAIN study of resminostat in CTCL - 4SC receives milestone payment

13 September 2018, Phase I study of 4SC's resminostat indicates efficacy in biliary tract cancer

Further information

About resminostat

Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body's immune response to cancer.

Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC. A Phase II study in biliary tract cancer is planned by 4SC's development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

About biliary tract cancer

Biliary tract cancers are highly lethal cancers that comprise a spectrum of carcinomas originating in the bile ducts, the gallbladder or the ampulla of Vater. According to epidemiologic studies the incidence has been increasing over the past few decades. In Japan, the incidence of biliary tract cancer and intrahepatic bile duct cancer is about 10 for every 100,000 people. These cancers typically have a poor prognosis, with 5-year survival rates in the range of 5 to 15%. In Japan, for patients with unresectable biliary tract cancer the combination of gemcitabine and cisplatin is recommended as the first-line chemotherapy. The oral fluoropyrimidine S-1 was also approved for biliary tract cancer in 2007 and is mainly used for second-line therapy.

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 will pay 4SC double-digit royalties linked to product sales of resminostat. Yakult Honsha is responsible for all clinical requirements for resminostat development in Japan in oncology indications.

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. Such drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies and provide a better quality of life.

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, 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 48 employees as of 31 December 2017 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).
 

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

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