4SC to present supportive preclinical data on resminostat's potential as maintenance therapy for CTCL

4SC AG (4SC, FSE Prime Standard: VSC) will present supportive preclinical data on the potential of the histone deacetylase (HDAC) inhibitor resminostat as maintenance therapy for advanced-stage cutaneous T-cell lymphoma (CTCL) at two conferences.

There are two HDAC inhibitors currently available in the U.S. to treat CTCL, but these are indicated only for treatment of patients with progressive disease and not for maintenance therapy. 4SC is currently enrolling advanced-stage CTCL patients in the RESMAIN pivotal study in 11 European countries to evaluate resminostat as maintenance therapy which could be an important additional therapeutic option for clinicians and patients.

The data presented at the following two conferences highlight the mechanistic rationale for pursuing a maintenance indication.

Epigenetics in Drug Discovery Session, Advances in Drug Discovery Conference

Poster: Resminostat – an epigenetic approach for CTCL maintenance treatment

Date: 6-7 March 2017

Location: Cambridge, United Kingdom

Clinical Epigenetics International Meeting

Poster: Resminostat – an epigenetic approach for CTCL maintenance treatment

Date: 9-10 March 2017

Location:Dusseldorf, Germany

Abstract summary

Progression of CTCL appears to be associated with a transition from Th1 to Th2 T-helper cell status that is related to altered expression of STAT4/STAT6. Resminostat’s ability to (1) induce apoptosis in several CTCL cell lines and (2) impact on STAT4/STAT6 expression were evaluated in preclinical experiments.

Resminostat demonstrated anti-tumor activity in CTCL cells at clinically relevant doses. Resminostat also increased STAT4 expression and decreased STAT6 expression, suggesting a stabilization of the less advanced CTCL stage (Th1) or even a reconversion of the advanced Th2 to the Th1 phenotype.

The poster will be published on 4SC’s website on Monday, 6 March 2017.

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 RESMAIN pivotal study is open for recruitment since November 2016 and is being conducted at more than 50 clinical centers in 11 European countries. 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. 4SC anticipates top-line data to be available in 2019.

About Resminostat

Resminostat is an orally administered histone deacetylase (HDAC) inhibitor with an epigenetic mechanism of action that potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and – in particular – in combination therapy with other anti-cancer drugs. As an inhibitor that blocks HDAC classes I, IIB and IV, resminostat can potentially offer benefit to patients as it inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body’s own immune response to cancer.

Resminostat has been shown to be well tolerated in patients with advanced cancers in Phase I studies. Its use in the treatment of cutaneous T-cell lymphoma (CTCL), Hodgkin's lymphoma and liver, lung, colon, pancreatic and biliary tract cancers has been and is being investigated in further clinical studies. Initial positive efficacy results for resminostat have – amongst others – been observed in combination with the standard medication sorafenib in selected patients with advanced liver cancer (hepatocellular cancer, HCC).

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve a number of 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.