4SC: Landmark RESMAIN study data presented at the 5th World Congress of Cutaneous Lymphomas

Resminostat (Kinselby) as a maintenance therapy is now clinically proven to postpone disease progression in advanced Cutaneous T-Cell Lymphoma (CTCL) which could significantly change current clinical practice.

Planegg-Martinsried, Germany, 11 April 2024 – 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 announces that renowned dermato-oncology expert and principal investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, will present data from the pivotal RESMAN study of resminostat (Kinselby) at the 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA, April 11-13, 2024.

The findings include:

• RESMAIN is one of the largest, randomized, controlled, clinical trials in cutaneous T-cell lymphoma (CTCL) to-date

·         Resminostat (Kinselby) as a maintenance treatment for advanced CTCL, is clinically proven to postpone disease progression in patients – a new treatment paradigm in CTCL

• Resminostat (Kinselby) showed a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916)
• The median time to next treatment (median TTNT) showed a significant improvement for resminostat (Kinselby) versus placebo, more than doubling to 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.428, 0.825)
• The side effects of resminostat were mainly mild to moderate, manageable and reversible

·         Additional analyses showed

• A clinically meaningful improvement in median “total” PFS (defined from start of last prior therapy to disease progression) of 24.3 months for patients treated with resminostat, compared to 14.9 months for those in the placebo group
• That resminostat (Kinselby) significantly delayed the development of new, or worsening of existing, skin tumours
• 4SC filed for Marketing Authorization approval in the European Union in February 2024.

Jason Loveridge, Ph.D., CEO of 4SC, commented: “We are proud to present these landmark data at such a renowned conference. Our unique treatment has been clinically proven to significantly slow disease progression in patients with advanced CTCL, providing hope where there are no curative treatment options. Our focus in the near term is on the registration and commercialisation of Kinselby in Europe, following our EMA marketing authorization application, in order to rapidly bring this therapy into clinical use.”

About 4SC

4SC AG 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 2023 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

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, 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 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 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) that 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 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.