New data supports resminostat’s mechanism of action in CTCL maintenance therapy

  • Resminostat beneficially modulates expression of genes associated with CTCL skin infiltration and disease progression
  • Poster presentations at the 25th Biennial Congress of the European Association for Cancer Research (EACR), 30 June – 3 July 2018, Amsterdam, The Netherlands

Planegg-Martinsried, Germany, 28 June 2018 – New preclinical data of 4SC AG (4SC, FSE Prime Standard: VSC) demonstrates that resminostat impacts the expression of a number of genes underlying the key biological mechanisms of cutaneous T-cell lymphoma (CTCL, a blood cancer affecting the skin).

Frank Hermann, M.D., Chief Development Officer of 4SC, said: “Resminostat is a histone-deacetylase inhibitor that reactivates silenced genes and downregulates excessively active genomic areas in cancer cells. In several CTCL cell lines we saw two highly interesting new effects: firstly, resminostat downregulates the expression of genes responsible for the capability of diseased cells to infiltrate the skin, and second, it beneficially modulates the expression of genes which, according to Litvinov et al., are associated with disease progression, an effect which supports our hypothesis that resminostat can significantly prolong time to progression for patients.”

Together with earlier data demonstrating that resminostat specifically downregulates the expression of the messenger molecule IL-31 associated with the severe itching in patients with CTCL, these new data add significantly to the understanding of how resminostat affects tumor cells to prevent disease progression. The data supports 4SC’s clinical development plans to advance resminostat to market authorization in order to offer a new and effective treatment option to CTCL patients and physicians in the maintenance setting.

4SC is currently investigating resminostat as maintenance therapy in the pivotal RESMAIN study in advanced-stage CTCL. RESMAIN top-line data are expected in 2019.

Poster presentations at the 25th Biennial Congress of the European Association for Cancer Research

Poster Epigenetic insights: Resminostat regulates targets associated with the pathogenesis of cutaneous T cell lymphoma (CTCL)
Session Experimental / Molecular Therapeutics, Pharmacogenomics
Time Sunday, 1 July 2018, 10:05 – 17:15 CEST
Location Poster Area, Hall 3
Poster Pre-clinical insight into how platelet count affects the activity of HDACi resminostat in combination with the multi-kinase inhibitor sorafenib in HCC
Session Experimental / Molecular Therapeutics, Pharmacogenomics
Time Monday, 2 July 2018, 10:05 – 17:15 CEST
Location Poster Area, Hall 3


Litvinov, I. V. et al. (2017). Gene expression analysis in Cutaneous T-Cell Lymphomas (CTCL) highlights disease heterogeneity and potential diagnostic and prognostic indicators. Oncoimmunology 6, e1306618.

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31 January 2018, Positive DSMB safety review of 4SC’s pivotal RESMAIN study of resminostat in CTCL

10 October 2017, Resminostat demonstrates potential to significantly alleviate itching in CTCL patients

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 and a Phase II study in biliary tract cancer 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 cutaneous T-cell lymphoma (CTCL)

CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.

Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable, halting disease progression, improving quality of life and prolonging progression free and overall survival.

About the RESMAIN study – Resminostat for maintenance treatment of CTCL

The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It will include 150 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) and have achieved disease control with systemic therapy. The patients are randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm.

The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival and the key secondary objective is to prolong the time to symptom worsening (itching). A comprehensive biomarker program is also included in the study to ensure vital knowledge about the biological background of resminostat treatment and CTCL is acquired.

The concept of maintenance therapy

The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma CTCL. Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organ can be involved. None of the current therapeutic options achieve stable disease for long periods, with most patients progressing within six months on average.

Resminostat is being evaluated as maintenance treatment – prolonging the period patients are stable and not progressing. Recent preclinical data further suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving the quality of life for patients.

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, 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 47 employees as of 31 March 2018 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.

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