ERYTECH to Present Preclinical and Clinical Data on Use of Eryaspase in ALL and AML at EHA 2018
The preclinical eryaspase data will be presented during Poster Session I by Dr.
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 website. The posters will be accessible on ERYTECH’s website at the start of each poster session.
About ERYTECH: www.erytech.com
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The Company’s lead product, eryaspase, also known under the trade name GRASPA®, consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
ERYTECH produces eryaspase at its own GMP-approved and operational manufacturing site in Lyon (
In addition to eryaspase, ERYTECH is developing erymethionase, methionine-γ-lyase encapsulated in red blood cells, to target cancer cells’ amino acid metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
CONTACTS
ERYTECH Naomi Eichenbaum Director Investor Relations |
NewCap Julien Perez Investor relations Nicolas Merigeau Media relations |
+33 4 78 74 44 38 +1 917 312 5151 naomi.eichenbaum@erytech.com |
+33 1 44 71 98 52 ERYTECH@newcap.eu |
Forward-looking information
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy, and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding the potential of ERYTECH’s product pipeline, its clinical development and regulatory plans for eryaspase, the timing of ERYTECH’s clinical studies and trials and announcements of data from those studies and trials, and the contents and timing of decisions by the
Source: Erytech Pharma S.A.