ERYTECH to Present Pharmacodynamic Data from Phase 2/3 Trial of Eryaspase in ALL at ASCO 2018
The European Phase 2/3 trial pharmacodynamic data will be presented during the poster session of the Hematologic Malignancies by Dr.
Co-Director of the proteomics and metabolomics core facility at
Poster Session: Pharmacodynamic Characterization of eryaspase (L-asparaginase Encapsulated in Red Blood Cells) in Combination with Chemotherapy in a Phase 2/3 Trial in Patients with Relapsed Acute Lymphoblastic Leukemia (NCT01518517).
Poster: | 7049 |
Lead Author: | Dr. Iman El Hariry |
Poster Session: | Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Location: | Hall A |
Date: | Monday, June 4 |
Time: | 8:00 a.m. – 11:30 a.m. |
This randomized Phase 2/3 study enrolled patients with relapsed ALL (n=80, age: 1-55 years), randomized to eryaspase or native ASNase in combination with chemotherapy. The study demonstrated prolonged asparaginase activity and marked reduction in allergic reactions with eryaspase, when compared with control native asparaginase. In addition, the study demonstrated an overall favorable safety profile as well as a higher complete remission (CR) rate with eryaspase.
The duration of asparagine (ASN) depletion was also evaluated in the study, and was inferior in the eryaspase arm, compared to control. These results are largely confounded by the lack of a reliable assay to measure ASN due to ex vivo depletion of ASN before the enzyme can be quenched. This can lead to over-estimation of ASN depletion with a free asparaginase enzyme, less so with an encapsulated enzyme. Importantly, ASN depletion ≤2 μM was maintained for approximately 7 days in 70% and 75% of patients, in the eryaspase and control arms, respectively. Of interest, correlation with complete remission rate suggests ASN depletion ≤2 μM may not be needed with eryaspase; rather, a level ≤7.55 μM at Day 6 may be sufficient.
The abstract is available on the
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.