4SC AG: 4SC AG – Discontinuation Domatinostat Program

Planegg-Martinsried (pta051/01.02.2022/19:00) - Planegg-Martinsried, Germany, 1 February 2022 – The Management Board and Supervisory Board of 4SC AG (FSE Prime Standard: VSC) today decided that as a result of a review of more recent clinical data 4SC discontinues the development program for domatinostat, an orally administered small molecule class I selective HDAC inhibitor.

4SC will now focus its resources completely on resminostat and on seeing an outcome to the ongoing pivotal RESMAIN study in CTCL and prepare for its commercialization in case of positive data. 4SC continues to be well funded and expects to have sufficient cash in-hand to obtain topline results from the RESMAIN study.

Jason Loveridge, Ph.D., CEO of 4SC commented: "As a company, we understand that developing new medicines for patients suffering from malignant diseases is an important, but difficult undertaking. Accordingly, we continually evaluate our development programs as data emerge to support prudent decisions that provide the greatest potential to create value for both patients and our shareholders.

It is of course disappointing that we have decided to discontinue development of domatinostat, including all currently ongoing clinical studies. The preclinical data we generated for the candidate were very persuasive, but the clinical information now available, and which will be published in due course, indicates that domatinostat is unlikely to provide value to patients, physicians, or shareholders. We thank the investigators, the patients, and support staff who have participated in this important research program and will now focus our resources on resminostat and expect to reach an outcome for our pivotal study in CTCL as planned in 2023."

- Press release ends -

Further information

About 4SC

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 41 employees as of 1 February 2022 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

About resminostat

Resminostat ( http://www.4sc.com/product-pipeline/resminostat/ ) is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.

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 by halting disease progression and improving patient’s quality of life.

About the RESMAIN study – resminostat for maintenance treatment of CTCL

The pivotal RESMAIN study ( https://clinicaltrials.gov/ct2/show/NCT02953301 ) is being conducted at more than 50 clinical centers in 11 European countries and Japan. It will include more than 190 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that 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 in CTCL.

About the concept of maintenance therapy

The pivotal RESMAIN study ( https://clinicaltrials.gov/ct2/show/NCT02953301 ) 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 organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within several months.

Resminostat is being evaluated as maintenance treatment - a unique innovative treatment approach in CTCL (Stadler et al., 2021) - intended to prolong the period patients are stable and not progressing. Furthermore, recent preclinical data suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving their quality of life.

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

4SC

ir-pr@4sc.com
+49 89 700763-0

(Ende)