Apogenix: Death Receptor CD95 Promotes Tumour Growth

Published: May 27, 2010

Heidelberg, May 27, 2010 – Apogenix GmbH, a protein therapeutic-based biopharmaceutical company specializing in malignant and inflammatory diseases, today announced the publication of an independent Nature article. This publication describes in vitro and in vivo studies of CD95: “CD95 promotes tumour growth” (Nature, May 27, 2010) by Professor Marcus Peter and his team, previously at the Ben May Department for Cancer Research, The University of Chicago Cancer Research Center, now in the Department of Medicine at the Northwestern Feinberg School of Medicine, Chicago, IL.

In vitro and in vivo data in this publication showed that cancer cells in general, regardless of their CD95 apoptosis sensitivity, depend on constitutive activity of CD95, stimulated by cancer-produced CD95L, for optimal growth. Results demonstrated that CD95 has a growth-promoting role during tumorigenesis and indicate that efforts to inhibit its activity rather than to enhance it should be considered during cancer therapy.

Professor Peter told Apogenix: “Our data indicate that the CD95/CD95L system, rather than being tumour suppressive, drives cancer growth - joining the ranks of TNFR1 and TNF-alpha in stimulating tumour growth. In line with our results, studies by other groups suggest that CD95 activates neuronal stem cells and acts as a tumour promoter for glioblastoma.”

Apogenix is developing APG101: a soluble CD95-Fc fusion protein that blocks CD95L from binding to the CD95 receptor, thus inhibiting tumour cell migration and invasive growth. APG101 is currently in Phase II trials to treat Glioblastoma multiforme (GBM), the most common and aggressive type of primary brain tumour. Results from the trial are expected in 2011.

Harald Fricke, CMO of Apogenix, said: “This is an independent confirmation of our approach to treating glioblastoma and potentially other tumours. Professor Peter and his team at the University of Chicago are highly respected for their studies on the activities of death receptors and the related signaling components in cell death as well as for the relevance of nonapoptotic activities in cancer development.”

With APG101 Apogenix intends to fundamentally improve the treatment of GBM. The goal of the current Phase II study is to achieve clinical proof-ofconcept for APG101.

About Apogenix

Apogenix, a spin-out from the German Cancer Research Center (DKFZ), is developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, based either on the targeted modulation of apoptosis (programmed cell death) or by blocking the invasive growth of tumour cells. The company is developing APG101, its lead product candidate, to treat Glioblastoma multiforme (GBM), the most common and aggressive type of primary brain tumour. APG101 is in preparation to enter Phase II trials for the treatment of acute Graft-versus-Host Disease (aGvHD), the rejection of recipient tissue by transplanted bone marrow. In preclinical studies, Apogenix is focusing on Interleukin-4 (IL-4) blockers. IL-4 plays an essential role in the development of apoptosis resistance in cancer cells and cancer stem cells. Since its inception in autumn 2005, the company has raised €43 million and has been awarded public grants totalling nearly €5.8 million. Apogenix is based in Heidelberg, Germany.

About APG101

The company’s lead product candidate, APG101, a soluble fusion protein combining the extracellular domain of the CD95-receptor and the Fc-portion of IgG, completed Phase I studies in 2009. In December 2009, APG101 entered a controlled Phase II trial for the treatment of Glioblastoma multiforme (GBM) and is in preparation to enter Phase II trials for the treatment of acute Graft-versus-Host Disease (aGvHD). Apogenix plans to out-license APG101 no later than the completion of proof of concept Phase II trials. Apogenix has been granted orphan drug status for APG101 to treat GBM in Europe and the U.S and for the prevention of aGvHD in Europe.

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