4SC AG (Frankfurt, Prime Standard: VSC) and Yakult Honsha Co.; Ltd. (Tokyo: 2267) today announced the grant of an exclusive license by 4SC to Yakult Honsha for the development and commercialization of resminostat in Japan. Resminostat, an oral, pan-histone deacetylase (HDAC) inhibitor, is currently being evaluated in Phase II trials by 4SC in hepatocellular carcinoma (HCC), Hodgkin lymphoma (HL) and colorectal cancer in KRAS-mutant patients (CRC). Yakult Honsha will develop and commercialise resminostat primarily in HCC, CRC and retains the rights to develop and commercialise resminostat in other oncology indications in Japan.

Terms of the Agreement

4SC will receive an upfront payment from Yakult Honsha of EUR6 million and up to EUR127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult will pay 4SC double-digit royalties linked to product sales of resminostat, which will also include the API costs. 4SC will be the exclusive supplier of resminostat to Yakult Honsha. Yakult Honsha will be responsible for all development and clinical requirements in Japan for resminostat in HCC, CRC and other chosen oncology indications.

Ulrich Dauer, CEO of 4SC, commented, 'We are pleased to be entering this partnership with Yakult Honsha, which validates the potential of resminostat and delivers on our partnering strategy. 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. We are looking forward to a mutually rewarding relationship and working together with this partner of choice.'

Shigeyoshi Sakamoto, Head, Pharmaceutical Division/Managing Director, Member of the Board, noted, 'We are delighted to establish a partnership with 4SC, an expert in research and development of novel drugs for cancer. We believe that resminostat will contribute to the treatment of difficult cancers such as HCC, for which treatment needs remain to be met, and also to the treatment of CRC and other types of cancer. The open-label Phase II trials data have provided us with the confidence to more aggressively develop the drug.'

More information about resminostat trials can be found on www.clinicaltrials.gov.

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About Resminostat

Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor. HDAC inhibitors modify the DNA structure of tumour cells to cause their differentiation and programmed cell death (apoptosis) and are therefore considered to offer a mechanism of action that has the particular potential to halt tumour progression and induce tumour regression. Resminostat is currently being investigated in the Phase II SHELTER study as a second-line treatment for advanced hepatocellular carcinoma, in the Phase I/II SHORE study as a second-line treatment in colorectal cancer in KRAS-mutant patients, as well as a third-line treatment in Hodgkin's lymphoma in the SAPHIRE trial.

In the HCC SHELTER study interim results from the first 13 patients assessed by tumor staging revealed that nine of them (69%) showed stable disease after six weeks of treatment. After 12 weeks of therapy six of 11 patients assessed to date (54%) displayed continued disease stabilization.

Interim results from the SAPHIRE trial in relapsed or refractory HL patients, based on the first Simon stage group of 18 patients, demonstrated that half of these patients experienced a clinical benefit from treatment with resminostat. Of those two patients could be assessed as partial responders (PR, i.e. with more than 50% reduction in size of tumour lesions). Seven patients displayed stabilization of their disease (SD) with diminished metabolic activities of their tumor lesions as examined by PET analysis (3/7 showed Partial Metabolic Response, PMR, with reduction of metabolic activity of their target lesions >25%, 4/7 showed Stable Metabolic Disease, SMD, with reduction of metabolic activity of their target lesions

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