On November 15, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the acceptance of an abstract with the results of its expanded access program (EAP) evaluating eryaspase in acute lymphoblastic leukemia (ALL) for poster presentation at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia and virtually (Press release, ERYtech Pharma, NOV 15, 2021, View Source [SID1234595525]).
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Abstract #1214: Expanded Access Program: Evaluating Safety of Erythrocytes Encapsulating L-Asparaginase in Combination with Polychemotherapy in Patients Under 55 Years Old with Acute Lymphoblastic Leukaemia (ALL) at Risk to Receive Other Formulations of Asparaginase
The eryaspase Expanded Access Program (EAP) was conducted at ten clinical sites in France and enrolled 18 patients. The EAP evaluated tolerability and biological efficacy in patients under 55 years of age with ALL, unable or at risk to receive any other available asparaginase formulation. Patients in this study had developed hypersensitivities to prior E-Coli- and Erwinia-derived asparaginase therapies.
Hypersensitivity is the most common cause of truncated asparaginase therapy which has been associated with decreased event free survival. In the EAP and consistently across eryaspase ALL studies, including the NOPHO1 study, eryaspase provides a sustained asparaginase enzyme activity level with few hypersentivity reactions and is generally well tolerated in combination with chemotherapy.
Eryaspase provides a promising additional option for patients for whom further asparaginase treatment is contraindicated. The company intends to move forward towards the submission of a BLA to the US Food and Drug Administration (FDA) for eryaspase in hypersensitive patients.
The study findings will be presented as a poster presentation by Prof Dr. Yves Bertrand, Institute of Pediatric Hematology and Oncology, Civil Hospital of Lyon, Lyon, France.