Corporate | 21 October 2014 07:30
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4SC AG / Key word(s): Patent
Press Release 4SC further strengthens patent protection for its lead compound resminostat – US Patent granted for the manufacturing process of resminostat – Resminostat manufacturing process is thus protected in all key global markets now – Worldwide composition-of-matter patent for resminostat already in place since 2013 Planegg-Martinsried, Germany, 21 October 2014 – 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, today announced that the company has further strengthened the patent protection for its lead anti-cancer compound resminostat. The US Patent Office has granted the patent for resminostat’s manufacturing process. The patent, which runs until 20 July 2029, protects the chemical process used in the manufacture of resminostat. This constitutes an additional obstacle for potential competitors while further extending the total term of resminostat’s portfolio of property rights. Overall, this means the resminostat manufacturing process is protected until 2029 in almost all key markets around the world, including Europe, Japan, China, Russia, Hong Kong, Singapore and Australia – and now the USA. This supplements worldwide protection for resminostat’s strategically important composition-of-matter patent, which was achieved on a global basis already in 2013. Enno Spillner, Chief Executive Officer of 4SC, said: “We are pleased to announce the protection of the resminostat manufacturing method in the world’s most important markets, in addition to its material composition. This contributes another strategically important element to our lead compound’s patent portfolio. We believe it is important to take action sufficiently early to prepare resminostat for a subsequent global marketing strategy.” Ends About Resminostat Resminostat (4SC-201), 4SC’s lead oncology compound, is an oral histone-deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, in particular in combination with other cancer drugs. Like other epigenetic therapies, resminostat has been shown to modify transcription of genes in cancer cells and, thereby, to reprogram the phenotypes of such cancer cells. Resminostat is therefore assumed to be able to halt tumour progression and induce tumour regression. Furthermore, due to its epigenetic mode of action resminostat is supposed to develop additional synergetic effects when combined with classical cancer therapies and thus also fight the development of tumour cell resistance. For example, in preclinical trials, resminostat has shown that it effectively inhibits epithelial-mesenchymal transition (EMT). EMT, which may be promoted through the administration of certain conventional cancer therapies, leads to the formation of particularly aggressive tumour cells, which ultimately may result in greater proliferation of cancer cells in patients and the patients’ death. On the whole, a reinforcing positive therapeutic effect is expected to be achieved through well-tolerated parallel administration of a traditional cancer therapy and an epigenetic compound such as resminostat. Resminostat – by 4SC and its Japanese partner Yakult – has been investigated in a broad clinical campaign comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin’s Lymphoma (HL), colorectal cancer (CRC), and non-small-cell lung cancer (NSCLC). In the Phase II SAPHIRE trial in patients with advanced Hodgkin’s Lymphoma (HL), resminostat monotherapy has demonstrated anti-tumour activity, with an overall response rate of 34% and a clinical benefit in 54% of the patients in a heavily pre-treated patient population together with very good safety and tolerability. In the Phase IIa SHELTER study resminostat has been evaluated as monotherapy and in combination with sorafenib as a second-line treatment in advanced HCC after proven radiological disease progression under first-line sorafenib therapy. Patients receiving the resminostat/sorafenib combination therapy showed a median overall survival of 8.1 months. The resminostat/sorafenib combination therapy had shown a progression-free survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 5.4 months. Notably, in both tumour indications, HCC and HL, gene expression levels of the new biomarker ZFP64 measured prior to study treatment start in blood cells of patients, were identified to be potentially indicative of survival outcome upon treatment with resminostat. Hereby, the set of patients with a high level of ZFP64 gene expression at baseline showed a statistically significant increase of median overall survival compared with patients with low ZFP64 expression levels. Resminostat was further studied in a Phase I dose escalation approach in advanced colorectal cancer (CRC) patients evaluating resminostat in combination with the standard chemotherapeutic FOLFIRI regimen. Positive results for safety and tolerability as well as promising signs of clinical activity of this combination were published at the 2013 ASCO conference. 4SC is currently in preparation of the next step to develop resminostat towards market approval in first-line HCC, a randomised-controlled, double-blind Phase II study evaluating the resminostat sorafenib combination compared to the current treatment standard sorafenib, as a first line treatment of advanced HCC. About 4SC The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops targeted, small-molecule drugs for treating diseases with high unmet medical needs in various cancer and autoimmune indications. These drugs are intended to provide innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. The Company’s pipeline comprises promising products that are in various stages of clinical development. 4SC’s aim is to generate future growth and enhance its enterprise value by entering into partnerships with leading pharmaceutical and biotech companies. Founded in 1997, 4SC had a headcount of 65 employees (55 FTEs) at 30 September 2014. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
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21.10.2014 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
| Language: | English | |
| Company: | 4SC AG | |
| Am Klopferspitz 19a | ||
| 82152 Martinsried | ||
| Germany | ||
| Phone: | +49 (0)89 7007 63-0 | |
| Fax: | +49 (0)89 7007 63-29 | |
| E-mail: | public@4sc.com | |
| Internet: | www.4sc.de | |
| ISIN: | DE0005753818 | |
| WKN: | 575381 | |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart | |
| End of News | DGAP News-Service |
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