IZB MARTINSRIED/MUNICH
IZB companies: new drug development highlights
IZB member companies 4SC AG, Evotec and SuppreMol have each made significant progress in their drug development programmes through alliances and licensing agreements. We report on the latest developments as well as on 4SC’s encouraging half-year results.
IZB member company 4SC AG has published overall survival data from a Phase 2 study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced liver cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, held in September. The international, open-label, two-arm SHELTER study enrolled patients with advanced liver cancer (hepatocellular carcinoma, HCC) who had shown proven radiological tumour progression under first- line therapy with the cancer drug sorafenib (Nexavar®). The study investigated safety and efficacy of resminostat as a monotherapy and in combination with sorafenib in this patient group with currently no approved treatment option. In both study arms, resminostat was proven to be safe and well tolerated. Notably, the overall health condition of the patients enrolled in the SHELTER study was particularly severe (measured by the clinical parameters ECOG status, BCLC stage and Child-Pugh class) compared to other clinical studies with alternative investigational drugs in second-line HCC patient populations. To 4SC’s best knowledge, the median overall survival in the resminostat/sorafenib combination group is the highest median value achieved to date in clinical studies investigating the efficacy of new treatment options for second-line advanced HCC in comparable patient populations who have shown proven radiological tumour progression on first-line sorafenib therapy. There is a particular high medical need for the development of new therapies for advanced HCC. To date, sorafenib is the only therapy approved for the first-line treatment of advanced HCC. For these HCC patients who have shown progressive disease on sorafenib there is no approved second-line treatment available.
Resminostat progression-free survival (PFS) efficacy data of the SHELTER study have been presented earlier this year at the Annual Meeting of the American Society of Clinical Oncology (ASCO). The data for the
with the previous year.
resminostat/sorafenib combination therapy showed one of the highest progression-free survival rate (PFSR) figures recorded to date by any second-line therapy in advanced clinical HCC studies. Dr Ulrich Dauer, CEOof 4SC, commented:
“We are very pleased with this study outcome. There is an enormous medical need in HCC especially after several investigational drugs, mostly protein kinase inhibitors, have recently failed in pivotal trials in this indication. Resminostat, as a leading HDAC inhibitor in advanced clinical development, offers a new and exciting therapeutic approach for advanced HCC: the use as a combination drug with sorafenib both in first-line and second-line HCC. We expect that the supplementary treatment with resminostat will restore or significantly improve the efficacy of the administered sorafenib therapy. I am confident that the impressive overall survival results from the SHELTER trial will give us further momentum for the preparation of our planned Phase 3 registration trial in combination with sorafenib in second-line HCC which we intend to start, preferably together with a partner, by mid 2013.”
4SC’s successful start continues in Q2 2012
4SC has also announced that the company has continued the successful start it made to the year in terms of strategy and operations and significantly improved its consolidated financial results in both the second quarter and the first six months of 2012 compared
As a result of increased revenue and reduced operating expenses, the operating loss of the company, which is currently still recording losses according to plan, improved by 18 per cent year-on-year to €7.8 million in the first half of 2012. Half-year revenue increased by 231 per cent to €0.73 million compared with H1 2011 boosted by the encouraging start to the research collaboration business of 4SC AG’s subsidiary 4SC Discovery GmbH, which commenced operations at the beginning of the year. The decline in operating expenses by 12 per cent to €8.57 million in the first half of 2012 is, in particular, attributable to the fall in research and development costs compared with the previous year due to the successful conclusion of a number of clinical trials. In terms of company funding, 4SC AG raised new funds totalling €12.61 million gross from a successful capital increase implemented in June and July, which is intended to enable the company to finance its next value-creating milestones and increase its cash reach.
www.4sc.de
Evotec enters strategic alliance with Janssen Pharmaceuticals
Evotec AG has licensed to Janssen Pharmaceuticals, Inc a portfolio of small molecules and biologics designed to trigger the regeneration of insulin-producing beta cells. Under the terms of the agreement, Janssen will receive exclusive access to a series of candidates designed to trigger the regeneration of insulin-producing beta cells. The small molecules and biologics were identified by scientists in the Harvard University laboratory of Douglas Melton, and further analysed in collaboration with scientists from Evotec, as part of Evotec and Harvard’s CureBeta research and development programme.
The agreement between Evotec and Janssen triggers an upfront payment of $8 million. Upon achievement of certain preclinical, clinical, regulatory and commercial goals, Janssen would make future milestone
September/October 2012 sp2 Inter-Active 31
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