4SC AG: 4SC announces update relating to Resminostat's (Kinselby) Marketing Authorisation Application

Planegg-Martinsried (pta002/07.01.2025/07:30) - Planegg-Martinsried, Germany, 7 January 2025 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today announced that it had submitted its responses to the Day-120 List of Questions from the European Medicines Agency (EMA) in December 2024 as planned, following 4SC's initial Marketing Authorisation Application (MAA) filing for resminostat (Kinselby) in March 2024. The EMA has notified 4SC that examination of the Company's MAA shall continue according to schedule.

The Day-120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process for resminostat (Kinselby), an orally available treatment for Cutaneous T-cell Lymphoma (CTCL).

Subject to the EMA's decision, marketing authorisation approval is expected around mid-2025. This filing moves resminostat (Kinselby) another step closer to market following Orphan Drug Designation from the EMA in 2023 and from the Swiss Agency for Therapeutic Products (SwissMedic) in September 2024.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "This filing marks a significant step forward for resminostat (Kinselby) as we progress ever closer to marketing authorisation approval, which is expected in mid-2025. We remain committed to bringing this much needed treatment to patients as soon as possible, and preparations for market launch are ongoing, as well as actively engaging with potential partners interested in commercializing the drug."

- Press release ends -

For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Nick Bastin, Vareen Outhonesack

Phone: +44 20 3922 0891

4SC@optimumcomms.com

About 4SC

4SC AG ( http://www.4SC.com ) is a clinical-stage biopharmaceutical company developing small-molecule drugs that target key indications in cancer with high unmet medical needs. 4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises one drug candidate in clinical development: Kinselby (resminostat).

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 15 employees as of 31 December 2024 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

About Kinselby (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 was investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.  

In 2023, the Company announced positive topline data from its RESMAIN study on resminostat (Kinselby), one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to-date, which showed

* A statistically significant improvement of 97.6% in progression free survival (PFS) compared to placebo (median PFS: 8.3 months versus 4.2 months)
* A median time to next treatment (median TTNT) versus placebo showed a significant improvement, more than doubling (8.8 months compared to 4.2 months)
* A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group
* The side effects of resminostat were mainly mild to moderate, manageable, and reversible.

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, and primarily affects the skin, but may ultimately involve lymph nodes, blood, and visceral organs.  

Currently, CTCL is incurable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available options; 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 ) was 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) and have achieved disease control with systemic therapy. The patients were randomized 1:1 to receive either resminostat or placebo. Patients who experienced disease progression – while being on placebo – were offered resminostat in an open label treatment arm.  

The primary goal of the study was to determine whether maintenance treatment with resminostat prolongs progression-free survival and other secondary objectives. Data demonstrating that resminostat met the primary endpoint of the RESMAIN study was published in May 2023.

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 a few 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.

(Ende)