On June 15, 2018 ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will present preclinical data on the enzymatic activity of eryaspase (GRASPA) for the treatment of relapsed acute lymphoblastic leukemia (ALL) and results of its Phase 2b clinical trial evaluating eryaspase (GRASPA) for the treatment of acute myeloid leukemia (AML) at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held June 14-17, 2018 in Stockholm, Sweden (Press release, ERYtech Pharma, JUN 15, 2018, View Source;p=RssLanding&cat=news&id=2354712 [SID1234527348]).
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The preclinical eryaspase data will be presented during Poster Session I by Dr. Karine Aguera, ERYTECH’s R&D Project Leader.
Poster Session: Preclinical Demonstration of Intracellular Activity of Asparaginase Encapsulated in Red Blood Cells Both in the Absence and in the Presence of Neutralizing Anti-Asparaginase Antibodies
Abstract #: PF160
Lead Author: Karine Aguera
Poster Session: Poster Session I
Location: Poster Area
Date: Friday, June 15, 2018
Time: 5:30 p.m. – 7:00 p.m. (CEST)
In these in vivo and in vitro preclinical studies, eryaspase was effective in reducing L-asparagine (ASN) levels, both in the presence and absence of neutralizing anti-asparaginase antibodies (nAbs). The preclinical findings, confirmed in additional in vitro experiments with eryaspase, support the theory that intra-cellular asparaginase activity may be responsible for the sustained effect on ASN reduction and can provide a more effective approach for the delivery of the L-asparaginase enzyme in patients with ALL, particularly in patients who have developed nAbs.
The AML Phase 2b trial data will be presented during Poster Session II by Dr. Mathilde Hunault of Centre Hospitalier Universitaire (CHU) d’Angers, France.
Poster Session: A Phase 2b of Eryaspase in Combination with Low-Dose Cytarabine as First-Line Therapy in Elderly Patients with Acute Myeloid Leukemia (ENFORCE – NCT01810705)
Abstract #: PS984
Lead Author: Xavier Thomas
Poster Session: Poster Session II
Location: Poster Area
Date: Saturday, June 16, 2018
Time: 5:30 p.m. – 7:00 p.m. (CEST)
The Phase 2b trial to evaluate the efficacy of eryaspase in elderly AML patients did not meet its primary endpoint to improve overall survival in this difficult-to-treat patient population. Patient selection is likely the most important factor, with enrolled patients remaining only briefly on treatment and unable to achieve a potential drug effect. Individualized risk stratification based on multi-parameter assessment tools and co-morbidity burden should be considered for older adults with AML participating in clinical trials.
ERYTECH also has an abstract on the incidence of Venous Thromboembolism (VTE) in 125 ALL patients, treated in five studies.
Abstract: Venous Thromboembolism in Patients with Acute Lymphoblastic Leukemia (ALL) Treated with Eryaspase (L-Asparaginase Encapsulated in Red Blood Cells)
Abstract #: PB1627
Lead Author: Yves Bertrand
Location: EHA Website Abstracts
The findings of this study show that the risk of VTE with eryaspase treatment in ALL patients was low and observed primarily in adults. The low incidence of these events may be related to decreased incidence of impaired coagulation parameters.
All of the abstracts are currently available on the EHA (Free EHA Whitepaper) website. The posters will be accessible on ERYTECH’s website at the start of each poster session.