DGAP-Adhoc

4SC Signs Licensing and Development Agreement with Menarini for Resminostat in Asia-Pacific Excluding Japan - Seite 3

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. Yakult Honsha is
currently developing resminiostat in two randomised clinical Phase II
trials in Japanese and Korean patients in the indications of HCC and NSCLC.