ERYASPASE
ERYTECH’s lead product is eryaspase, which consists of L-asparaginase (L-ASNase) encapsulated inside donor-derived red blood cells, targeting cancer cells’ altered asparagine metabolism, while remaining biologically active with a half-life of approximately two weeks. Since cancer cells are unable to produce their own asparagine, treatment with L-ASNase induces cell cycle arrest, leading to starvation/killing of certain cancer cells, and is currently used for the treatment of acute lymphoblastic leukemia (ALL). ERYTECH is now exploring the clinical utility of eryaspase in pancreatic cancer, which is a significant cause of cancer mortality, and treatment options are limited as the disease is usually advanced at diagnosis. Single-agent eryaspase in metastatic pancreatic adenocarcinoma patients was well-tolerated in a Phase 1 trial, while improvements in overall survival (OS) and progression-free survival (PFS) in combination with chemotherapy were observed in a later Phase 2b trial. Currently, ERYTECH is conducting a Phase 3 trial in which eligible metastatic pancreatic cancer patients are randomized to test the effects of eryaspase in combination with chemotherapy versus chemotherapy alone (NCT03665441). In addition, the role of eryaspase in patients with ALL who have hypersensitivity to pegylated asparaginase (PEG-ASNase) is being explored. Results from a NOPHO-sponsored Phase 2 trial demonstrated that twice-weekly eryaspase in combination with chemotherapy, provides a sustained asparaginase enzyme activity level, and is generally well tolerated with few hypersensitivity reactions. The trial results were presented at the 62nd ASH Annual Meeting held in December 2020. The investigators concluded that eryaspase is an attractive treatment option for patients who have developed hypersensitivities to PEG-ASNase. Erytech recently announced its intention for a pre-BLA meeting with the US FDA to discuss a route forward to approval in this indication....
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