On August 24, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a regulatory update, that it is no longer seeking approval for Graspa in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the U.S. Food and Drug Administration (FDA) (Press release, ERYtech Pharma, AUG 24, 2022, View Source [SID1234618656]).
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"We are obviously disappointed to stop the process of seeking approval for Graspa in ALL after all the work done and clinical promise observed in this indication," said Gil Beyen, Chief Executive Officer of ERYTECH. "In multiple clinical trials, Graspa showed promising results for patients, and we were encouraged by the dialogue with the FDA and the Fast Track designation that we received for this indication last year. However, the changing competitive landscape, combined with new FDA’s requests for additional clinical data that would require significant additional resources on our part, led to the difficult decision to stop the development of Graspa in ALL. We are now focusing our resources on our most promising preclinical programs, while pursuing strategic partnering options to maximize value for our shareholders and employees."
Following positive results of a Phase 2 trial, sponsored by the Nordic Organization for Paediatric Haematology and Oncology (NOPHO), presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, ERYTECH has been in discussions with the FDA for the approval of Graspa to treat ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy.
A meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021, after which the Company confirmed its intention to submit a BLA, subject to the submission of additional requested information to the FDA and agreement on an Initial Pediatric Study Plan (iPSP).
The Company recently received feedback from the FDA on its iPSP, submitted in July 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, the Company has determined that it is in the best interests of the Company and its shareholders to no longer seek approval for Graspa in ALL and to focus its resources on its preclinical programs and strategic partnering activities.
Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022, the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and the Company expects to give further updates on these strategic initiatives in the fourth quarter of this year.