• The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA) and rapporteurs are expected to be appointed in July 2023

• EMA has notified 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG)

4SC AG (4SC, FSE Prime Standard: VSC) announced that the European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a MAA and has informed 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG).

If approved by regulatory authorities, Kinselby (resminostat) would be the first HDAC inhibitor approved in Europe for CTCL and the first and only drug approved for maintenance therapy in this disease, making it the Company’s most valuable asset. The positive outcome to RESMAIN creates an opportunity to either sell, license or partner 4SC’s resminostat program for commercialization worldwide (excluding Japan), where Yakult Honsha Co. Ltd, was granted an exclusive license for the development and marketing of resminostat in Japan in 2011.

Jason Loveridge, CEO of 4SC: "This is another key milestone for 4SC in moving resminostat to market in the EU. Now we have an accepted tradename for resminostat we will continue preparation of our MAA and the commercialisation of Kinselby for the benefit of all stakeholders".

About Kinselby (resminostat)  

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 is being conducted at more than 50 clinical centers in 11 European countries and Japan. It included 201 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients were 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 other secondary objectives.

About 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 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.

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.