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Agreements

Date: 2015-07-28

Type of information: Development agreement

Compound: companion diagnostic tests for APG101

Company: Apogenix (Germany) R-Biopharm (Germany)

Therapeutic area: Cancer - Oncology

Type agreement:

development

Action mechanism:

companion diagnostic/fusion protein. APG101 is a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG. The interaction between the CD95 ligand and the CD95 receptor activates an intracellular signaling pathway that stimulates the invasive growth and migration of tumor cells, such as glioblastoma cells. APG101 binds to the CD95 ligand and thus inhibits activation of the CD95 signaling pathway, resulting in reduced tumor cell growth and migration. APG101 was granted orphan drug status for the treatment of glioma (EU/3/09/709) in the EU and for the treatment of glioblastoma and myelodysplastic syndromes in the US.

Disease:

Details:

* On July 28, 2015, Apogenix announced  that it has entered into an agreement with R-Biopharm, a global provider of innovative clinical diagnostics, to develop companion diagnostic tests for Apogenix’ lead drug candidate APG101. APG101 is a CD95 ligand inhibitor which restores the body’s immune response against tumors and inhibits invasive tumor cell growth. The drug candidate is being developed for the treatment of solid tumors and malignant hematological diseases. Apogenix and R-Biopharm will develop patient-stratifying companion diagnostic tests to identify glioblastoma patients who are most likely to benefit from treatment with APG101. The cooperation further includes the development of in vitro diagnostic tests to determine expression of the CD95 ligand in other types of tumors. Apogenix will validate the resulting diagnostic tests in a pivotal phase II/III trial in glioblastoma and in additional clinical trials for the treatment of other solid tumors.

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