Alliance includes €127 million in milestones for HDAC inhibitor resminostat.

Yakult Honsha is paying 4SC €6 million (about $8.5 million) up front and potentially another €127 million (roughly $183 million) in development and regulatory milestones for an exclusive license to develop and commercialize resminostat (4SC-201) in Japan. 4SC is currently taking the oral pan-histone deacetylase (HDAC) inhibitor through Phase II trials against hepatocellular carcinoma, Hodgkin lymphoma, and colorectal cancer in Kras-mutant patients. Yakult will focus on development of resminostat for the hepatocellular carcinoma and colorectal cancer, but retains rights to the drug for other oncology indications in Japan.

The firm will be responsible for all development and clinical activities in its licensed territory. 4SC will receive double-digit royalties on future sales, including costs of the API, which 4SC will supply to Yakult.

“As Yakult Honsha is the market leader in the gastrointestinal oncology field in Japan, we have found the most suitable partner for our core indications: hepatocellular carcinoma and colorectal cancer,” notes Ulrich Dauer, 4SC’s CEO.

Resminostat is designed to modify the DNA structure of tumor cells and trigger their differentiation and apoptosis, 4SC explains. Interim data from the ongoing Phase II Shelter hepatocellular carcinoma study showed that 9 of the  first 13 enrolled patients showed disease stabilization after six weeks of treatment. Six of these patients continued to display disease stabilization after 12 weeks of therapy. Shelter is evaluating resminostat either alone or in combination with sorafenib (Nexavar®), as second-line therapy for advanced hepatocellular cancer. Additional ongoing studies include the Phase I/II Shore study evaluating resminostat as second-line treatment of colorectal cancer in Kras-mutant patients, and the Saphire study evaluating the drug as third-line treatment of Hodgkin lymphoma in patients who are refractory or relapse after chemotherapy.

4SC’s lead clinical candidate is vidofludimus, an orally administered small molecule disease modifying antirheumatic candidate in development for autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. 4SC claims the drug has a dual mechanism of action that inhibits both IL-17 and the dihydroorotate dehydrogenase enzyme.

Vidofludimus is currently being evaluated in a Phase IIb study in combination with methotrexate against rheumatoid arthritis, and an exploratory Phase IIa study in inflammatory bowel disease.  The therapeutic efficacy of vidofludimus is based on a dual mechanism of action that inhibits the cytokine interluken-17 (IL-17) and the dihydroorotate dehydrogenase enzyme (DHODH).

Just yesterday 4SC announced treating the first patient in a Phase I study with the selective histone deacetylase (HDAC) inhibitor 4SC-202, in patients with advanced hematological indications, including acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, myelodysplastic syndrome, and lymphomas.

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