An alle, ich muss meine Postings dringend koregieren. Warum der Sinneswandel...?? Ich habe nach längerer Reserche ein paar Details bzw. Fakkten übersehen !! Deshalb halte ich an einem Kursziel von 17 € für nicht zu hoch gegriffen. 4SC könnte die nächste Dendreon oder Human Genome Science werden. Der Baustein bzw. die Grundlage ist schon mal geschafft. Einen zusätzlichen Hebel stellt die EU dar, die 4SC entsprechend fördert. Hier ein paar Fakkten von 4SC: Investment summary: Study read-outs in 2011 Results of three Phase II studies, one with vidofludimus and two with resminostat, largely define 4SC’s investment case. All of these are due to render results this year and, if positive, should put 4SC in a strong position to secure development partnerships for these two key compounds with major pharmaceutical groups. A positive result has already been obtained in the ENTRANCE study of vidofludimus in IBD. Two other compounds are also in early-stage studies. We continue to indicate a valuation of €225m, excluding cash, based solely on the risk-adjusted net present value of the key clinical stage programmes. In our view, this should become better recognised with positive clinical trial results. There should be significant upside associated with successful partnering activity. Investment summary: BD activity on positive studies 4SC is a Munich-based biotech company focused on the development of small molecule compounds for autoimmune disease and cancer. The R&D pipeline consists of four clinical stage compounds with a further two at the pre-IND stage (Exhibit 1). The outcome of three clinical studies – one with vidofludimus and two with resminostat – largely define the investment case, all of which should render results in 2011. Review: Three key studies to complete this year Results of three Phase II studies, one with vidofludimus and two with resminostat, largely define 4SC’s investment case. All are due to render results this year and, if positive, should put 4SC in a strong position to secure development partnerships for its two key compounds with major pharmaceutical groups. The most important of these studies is COMPONENT, which explores vidofludumus in rheumatoid arthritis (RA) and should read out in early Q2. Encouraging initial safety and efficacy data from the ongoing SAPHIRE study with resminostat in relapsed/refractory Hodgkin’s Lymphoma (HL) were presented at the American Society of Hematology last month. Ten out of the 18 evaluable patients (55%) showed clinical benefit, mostly stable disease, with two partial responders (11%). The study has progressed to the second stage of its two stage design (which required it to have achieved Patients were assessed for efficacy on the basis of combined Cheson and EORTC response criteria. Almost all of the 18 patients were determined to be partial metabolic responders (a >25% decrease in PET activity) under EORTC criteria and the two partial responders showed a >50% reduction in size of tumour lesions, per Cheson criteria. One of the partial responders is described in a case report as a 47 year old male who had been diagnosed with HL in 2000 and has since received multiple prior treatment regimens. This patient was showing a partial response at cycle six and a partial metabolic response at cycle three; both were maintained at cycle 10, an impressive result. First-line standard treatment of HL is combination chemotherapy of ABVD ≥5 responses in first stage), allowing a further 15 patients to be recruited. Resminostat was sufficiently well tolerated at 600mg qd (with mild to moderate GI and haematological side effects) to allow an optional increase to 800mg qd in the second stage. The most common grade 2-3 AEs were anaemia and thrombocytopenia, which were manageable with dose modification or symptomatic treatment. 1 or MOPP2and usually achieves a very high response rate. Second-line treatment is salvage/high-dose chemotherapy and autologous stem cell transplantation. However, there is no standard of care for patients who become resistant to second-line treatment. 1 ABVD = Adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine. 2 MOPP = mechlorethamine, Oncovin (vincristine), prednisone and procarbazine. There are a large number of studies underway in HL, but most are academic-sponsored trials involving combinations of approved drugs and/or exploratory studies in a broader patient lymphoma population that includes HL. Resminostat is one of three HDAC inhibitors in development for HL; the others being Novartis’s panobinostat and Syndax’s entinostat. Panobinostat is in a Phase III study – a registration submission based on interim data was planned for 2010 (although has not been confirmed as having taken place). The other key late-stage programme with a single agent is Seattle Genetics’s brentuximab vedotin, which is in a 322-patient Phase III study (AETHERA) in residual HL following stem cell transplant. Details of the SAPHIRE study as well as the SHELTER study for hepatocellular carcinoma (liver cancer) and the planned Phase II study in colorectal cancer (SHORE) are shown in Exhibit 2 (overleaf).
http://www.stockopedia.co.uk/research/study-read-outs-in-2011-51986/ Other studies underway or commencing Two other programmes are in early clinical development (4SC-203 and 4SC-205), with a fifth compound (4SC-202) due to enter studies shortly. Valuation: Significant upside based on partnering Positive result in IBD bodes well for vidofludimus in RA In October last year, 4SC reported a highly positive outcome to the ENTRANCE study of vidofludimus in IBD, which showed a total response rate of 88.5%, compared with around 20% for historical placebo controls. This bodes well for the RA indication, explored in the COMPONENT study, which is 4SC’s key value driver. Encouraging signal for resminostat in HL Data from 18 patients in the first stage of the two-part SAPHIRE trial of resminostat in Hodgkin’s lymphoma were presented at ASH last month. These confirmed 10 patients (55%) experienced clinical benefit, mostly SD with two PRs (11%). Full results including the second stage (15 patients) – some of which may receive a higher dose – are likely in the mid-year. Resminostat is also in the SHELTER study for liver cancer and is due to enter a third Phase II (SHORE) in colorectal cancer shortly. |
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