Date: 2011-04-14
Type of information: Licensing agreement
Compound: resminostat
Company: 4SC (Germany) Yakult Honsha (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: Licensing
Development
Commercialisation
Action mechanism:
Disease: hepatocellular carcinoma - colorectal cancer
Details: 4SC AG has granted an exclusive license to Yakult Honsha for the development and commercialization of resminostat in Japan. Resminostat 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.
4SC will receive an upfront payment from Yakult Honsha of € 6 million and up to € 127 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.
Financial terms: upfront payment of € 6 million and up to € 127 million payable upon achieving specified milestones including clinical and regulatory events
Latest news: 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 <25%).
SHORE trial will evaluate the efficacy, safety and pharmacokinetics of Resminostat as a second-line treatment in combination with FOLFIRI, a chemotherapy regimen for the treatment of colorectal cancer for patients with advanced and metastatic colorectal KRAS-mutant cancer. The first patient in the trial has been dosed in January, 2011.
