Asunercept
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Asunercept (INN; development codes APG101 and CAN008)[1] is a soluble CD95-Fc fusion protein which is in clinical development for the treatment of glioblastoma multiforme (GBM) and myelodysplastic syndromes (MDS).[2] Asunercept has been granted orphan drug status for the treatment of GBM and MDS in the EU and the US.[3][4][5] It has also received PRIME designation by the European Medicines Agency (EMA) for the treatment of GBM.[6]
Mechanism of action
[edit | edit source]Asunercept blocks the CD95–ligand (CD95L) from binding to the CD95-receptor (CD95), which induces apoptosis. In oncology, this blockade is intended to prevent the killing of activated T cells[7] that can be induced by tumor-associated macrophages (TAMs),[8] endothelial cells,[9] or fibroblasts.[10]
In MDS, CD95L-signaling is a negative regulator of erythrocyte production in the bone marrow and its blockade has been shown to rescue erythroid progenitors.[11]
Clinical development
[edit | edit source]A randomized, double-blind, placebo-controlled phase I study to examine the safety and tolerability of asunercept has shown that it is well tolerated.[12] The efficacy of asunercept was tested in a phase II randomized controlled trial for patients with GBM. A total of 83 patients with first or second relapse of GBM were enrolled in the successful proof-of-concept trial. The primary goal of doubling the number of patients reaching progression-free survival at six months (PFS6) was substantially exceeded.[13]
Asunercept has also been successfully tested in a phase I trial to treat patients with MDS.[14] MDS is a disease in which the bone marrow does not make enough healthy blood cells, which leads to blood cytopenias, especially anemia.[15]
References
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