On December 7, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients, which were presented by Dr. Line Stensig Lynggaard at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting yesterday (Press release, ERYtech Pharma, DEC 7, 2020, View Source [SID1234572280]). In a webcast later today, Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, will comment on the data and be available for Q&A.

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The Phase 2 NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. The trial was conducted by the Nordic Society of Pediatric Hematology and Oncology (NOPHO) at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. Primary objectives of the trial were asparaginase enzyme activity and safety. Both endpoints were met.

Eryaspase demonstrated sustained asparaginase enzyme activity above the threshold of >100 U/L at trough levels, 14 days after first infusion in 54 of the 55 patients treated.

Eryaspase was generally well tolerated when added to chemotherapy and almost all patients were able to receive the intended courses of asparaginase (median of 5 doses per patient). Of the 55 patients, only 2 patients had severe allergic reaction and withdrew eryaspase treatment.

Dr Line Stensig Lynggaard, the study leader for NOPHO, commented: "Maintaining adequate asparaginase treatment following hypersensitivity to PEG-asparaginase remains an important goal when treating patients with ALL. A global shortage of supply Erwinia-derived asparaginase, which is the current alternative treatment option to PEG-asparaginase, highlights the need for new alternative treatment options. Our study has demonstrated that eryaspase, given as a convenient schedule every two weeks, provides a sustained asparaginase enzyme activity level, few hypersentivity reactions and is generally well tolerated in combination with chemotherapy. We conclude that eryaspase is an attractive treatment alternative for ALL patients with hypersensitivity to PEG-asparaginase."

"We are proud to be working with the NOPHO group in conducting this study in ALL and very grateful to them for presenting the findings at ASH (Free ASH Whitepaper) this year. The full study results provide the possibility of an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase" said Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer. "We look forward to discussing further the potential path forward for eryaspase in ALL with regulatory authorities, including the FDA".

A related eryaspase poster will be presented by Dr. Frank Hoke (ERYTECH’s Head of Clinical Pharmacology) on Monday 7th December 2020 from 8am PST / 11am EST / 5pm CET.

Abstract #2799: Population Pharmacokinetics of Eryaspase in Patients with Acute Lymphoblastic Leukemia or Pancreatic Adenocarcinoma

The analysis shows the extended circulation time of eryaspase, provides information on patient factors that influence the exposure of eryaspase, and evaluates patient population (pancreatic cancer vs ALL) and formulation (native vs recombinant asparaginase). Specifically, the simulations demonstrate that 100 U/kg dosed every two weeks would achieve the clinical AEA target levels of 100 U/L at trough in approximately 95% of patients.

The abstract (#2799) can be found at: View Source

Webcast Details

ERYTECH will hold a webcast later today, Monday, December 7, at 4:00 pm CET / 10:00am ET.

Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, Dr. Iman El-Hariry, Chief Medical Officier of ERYTECH Pharma, and Gil Beyen, Chief Executive Officer of ERYTECH Pharma, will comment on the data and be available for Q&A.

The webcast can be followed live online via the link: View Source

Conference ID#: 2272914#

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.