Graspa’s last gasp

The long and painful journey of Erytech’s leukaemia project Graspa has come to an end. Four years after the EU filing for the L-asparaginase formulation was pulled (for the second time), Erytech has given up trying to get it approved in the US. The aim with Graspa had been to improve on the profile of L-asparaginase, a standard component of chemotherapy for ALL, by encapsulating it in donor-derived red blood cells to protect it from breakdown, but development stalled for various reasons. An EU filing had been submitted based on 80-patient data back in 2015, but after the EMA informed Erytech that it was not convinced of Graspa’s safety the group withdrew the file. It then decided to focus on developing Graspa for solid tumour indications, but academic data in ALL patients who were “hypersensitive” to standard L-asparaginase appeared to provide a path forward in the US. But then solid tumour trials bombed, and the FDA approved a rival asparaginase product, Jazz’s Rylaze. Erytech’s US filing plans went into a protracted delay – which mercifully ended yesterday. Erytech, 90% off its 2013 IPO price, sold a production plant in April, and is evaluating “strategic options”.