4SC files maintenance CTCL therapy Kinselby in EU

4SC’s chief executive Jason Loveridge
Jason Loveridge via LinkedIn

4SC’s chief executive Jason Loveridge

German biotech 4SC has filed its oral HDAC inhibitor Kinselby with the EMA, hoping to provide a much-needed new therapy for patients with the rare cancer cutaneous T-Cell lymphoma (CTCL).

CTCL is a group of non-Hodgkin lymphoma (NHL) diseases that tend to be slow-growing, but can cause debilitating symptoms, including extensive rashes, redness and scaly patches on the skin, and skin tumours. It can become life-threatening as tumours spread to other organs and tissues and, in advanced cases, median overall survival is less than five years.

There is no curative treatment at the moment, although, various drugs including chemotherapy, retinoids, interferons, other HDAC inhibitors (only in the US market), and Kyowa Kirin’s anti-CCR4 antibody Poteligeo (mogamulizumab) have been shown to drive the disease into remission.

4SC maintains that Kinselby (resminostat) has the potential to become a practice-changing therapy for advanced-stage CTCL as the first approved maintenance therapy that can prevent relapse and postpone progression.

The filing is based on the results of the RESMAIN study, which showed that maintenance therapy with Kinselby after initial treatment of CTCL extended progression-free survival to 8.3 months from 4.2 months in patients assigned the standard approach of ‘watchful waiting’ plus placebo.

The HDAC inhibitor also improved median total PFS to 24.3 months, compared to 14.9 months for placebo, and extended the time to next treatment (TTNT) from 4.2 months to 8.8 months with side effects that were “mainly mild to moderate, manageable, and reversible,” according to the biotech.

“The team has worked hard to successfully file the marketing authorisation application for resminostat in CTCL ahead of schedule,” said 4SC’s chief executive, Jason Loveridge.

“This represents a significant step forward for 4SC […] as it further de-risks our resminostat programme and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders.”

If approved, Kinselby will be 4SC’s first commercial-stage product, and the company has been seeking out a commercial partner to help bring the drug to patients in Europe and other markets. It already has a partner in Japan, Yakult Honshu, which is preparing to file for approval there in the first half of this year.

Applications in the UK and Switzerland are also planned, and 4SC has started discussions with the FDA over a possible filing in the US.

The company was sitting on cash reserves of just over €10 million as of the end of September last year, but with RESMAIN now finished has said that should see it through to the third quarter of this year. It has predicted that Kinselby sales could be worth around €600 million in Europe alone over 10 years.