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”.

Graspa's long and painful journey
Aug 2022 US filing will not be pursued
Apr 2022 US filing is planned for Q3
Mar 2022 US filing is planned for Q2 "if FDA allows to file"
Jan 2022 US filing is planned for Q1
Nov 2021 Erytech stops Graspa's TNBC trial
Oct 2021 After readout delays Graspa fails in pancreatic cancer, OS HR=0.92 (p=0.375)
Jul 2021 US filing is planned by end 2021, in "hypersensitive" ALL
Dec 2020 Ash data on academic trial in ALL patients with hypersensitivity to pegylated asparaginase 
Jul 2018 EU filing is pulled for 2nd time; focus switches from ALL to solid tumours
Oct 2017 EU filing is resubmitted
Nov 2016 EU filing is pulled for 1st time, to allow more data generation
Sep 2016 Expected EU approval is delayed from late 2016 to 2017, to address some issues
Sep 2015 Graspa is filed for ALL in the EU
ALL=acute lymphoblastic leukaemia. Source: company filings.

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