ERYTECH announces the publication of positive results from the Eryaspase Phase 2 trial in hypersensitive ALL in the British Journal of Hematology

ERYTECH announces the publication of positive results from the Eryaspase phase 2 trial in hypersensitive ALL

in the British newspaper of Hematology

• The study confirms the potential of eryaspase (GRASPA®) as an attractive treatment option for acute lymphoblastic leukemia (ALL) patients with hypersensitivity to PEG-asparaginase
  

Cambridge, MA (USA) and Lyon (France), April 06, 2022– Erytech Pharma Inc. (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today Announces Results of Phase 2 Trial Sponsored by NOPHO eryaspase in ALL patients are now published in the British newspaper of Hematology.

The NOR-GRASPALL-2016 Phase 2 trial evaluated the safety and pharmacological profile of eryaspase in patients with ALL who had previously experienced hypersensitivity reactions to pegylated asparaginase treatment. 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. The main objectives of the trial were the activity and safety of the enzyme asparaginase. Both endpoints were met.

Eryaspase demonstrated sustained above-threshold asparaginase enzyme activity of >100 U/L at trough levels 14 days after the first infusion in 92.5% of patients. Eryaspase was generally well tolerated when added to chemotherapy, and almost all patients were able to receive planned courses of asparaginase (median of 5 doses per patient). Of the 55 patients, only 2 patients had a severe allergic reaction and discontinued treatment with eryaspase.

The principal researcher,dr. Birgitte Klug Albertsenassociate professor at Aarhus University Hospital, Denmark, commented, “I amrecognizing that the editors of theBritish newspaper of Hematologyselectedour study for publication. The study demonstratedthis eryaspasegiven as aconvenient bi-weekly schedule, provides sustained asparaginase enzymeactivity levelI above recommendationthreshold for othersAsparaginasetreatments, few hypersensitivity reactions and is generally well toleratedin combination with chemotherapy. We conclude that andryaspaseseems to bea promisingprocessing alternative for all patients with hypersensitivity toPEG-asparaginase.”

“We are proud to work with the NOPHO group in conducting this ALL study, and hope that the study results will provide the possibility of an alternative treatment for ALL patients with hypersensitivity to PEG- asparaginase.” said Dr. Iman El-Hariry, Medical Director of ERYTECH. “We have an ongoing dialogue with the US FDA regarding possible regulatory approval in this indication based on the NOPHO sponsored trial..”

The paper: “Asparaginase encapsulated in erythrocytes as second-line therapy in hypersensitive patients with acute lymphoblastic disease Leukemia” by Line Stensig Lynggaard, Goda Vaitkeviciene, Cecilia Langenskiöld, Anne Kristine Lehmann, Päivi M. Lähteenmäki, Kristi Lepik, Iman El Hariry, Kjeld Schmiegelow and Birgitte Klug Albertsen, can be viewed online at https://doi.org/10.1111/bjh.18152appearing in British newspaper of Hematology, 2022;00:1–10posted by Wiley.

For more information and copies of the document, please contact Wiley at https://wolsupport.wiley.com/s/

On 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 United States and Europe. More than 13,000 cases are diagnosed each year in the United States and Europe, with the majority of patients being diagnosed
before the age of 20. Asparaginase has been an integral part of the treatment of ALL for many years, but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in patients with ALL has been associated with
lower event-free survival highlighting the need for additional asparaginase-based treatment options.

About ERYTECH and eryaspase (GRASPA®)

ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies based on red blood cells for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses novel technology to encapsulate drug substances within red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH is primarily focused on the development of product candidates that target the altered metabolism of cancer cells by depriving them of the amino acids necessary for their growth and survival.

The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated in donor red blood cells, targets the impaired asparagine and glutamine metabolism of cancer cells. Proof of concept of eryaspase as a cancer metabolism agent has been established in different trials in acute lymphoblastic leukemia (ALL) and pancreatic cancer. An investigator-sponsored Phase 2 (IST) trial evaluating the use of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase recently reported positive results, based on which the Company intends to seek approval in the United States and potentially in other territories. The Company is also pursuing a Phase 1 clinical trial sponsored by a front-line pancreatic cancer researcher.

Eryaspase has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of advanced pancreatic cancer and the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity reactions to pegylated asparaginase derived from E. coli. The FDA and the European Medicines Agency have granted eryaspase orphan drug status for the treatment of pancreatic cancer and ALL.

ERYTECH produces its product candidates for the treatment of patients in Europe at its GMP approved manufacturing site in Lyon, France, and for patients in the United States at its GMP manufacturing site in Princeton, New Jersey, USA. Eryaspase is not an approved drug.

ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the regulated market of Euronext in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indices.

For more information, please visit www.erytech.com

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avant-garde Iinformation

This press release contains forward-looking statements, including, but not limited to, statements regarding the clinical development and regulatory plans of eryaspase, including the timing of a potential BLA submission to the FDA for treatment of acute lymphoblastic leukemia, the Company’s ability to obtain regulatory approval for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity reactions to PEG-asparaginase, the Company’s ability to expand the field indication of eryaspase, the Company’s ability to obtain additional financing under the OCABSA financing agreement or other financing attempts, and the Company’s anticipated cash flow. Some of these statements, forecasts and estimates can be recognized by the use of words such as, but not limited to, “believes”, “anticipates”, “expects”, “intends”, ” plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. These statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were believed to be reasonable at the time they were made, but which may or may not prove to be correct. Actual events are difficult to predict and may depend on factors beyond ERYTECH’s control. There can be no assurance with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or prove to be commercially successful. Accordingly, actual results and timing may differ materially from any anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. A more detailed description of these risks, uncertainties and other risks can be found in the regulatory documents filed by the Company with the Autorité des marchés financiers (AMF), the documents and reports of the Securities and Exchange Commission (SEC) of the Company, including in the Company’s 2020 Information Document. Universal Registration filed with the AMF on March 8, 2021 and in the Company’s Annual Report on Form 20-F filed with the SEC on March 8, 2021 and future Company filings and reports. Given these uncertainties, no representation is made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Further, forward-looking statements, forecasts and estimates speak only as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update such forward-looking statements, forecasts or estimates to reflect any change in ERYTECH’s expectations in this regard, or any change in events, conditions or circumstances on which such statement, forecast or estimate is based. , except to the extent required by law. Additionally, the COVID-19 pandemic and associated containment efforts have had a severe negative impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on the Company’s business and operations are highly uncertain, and such impact includes effects on its clinical trial operations and supply chain. Factors that will influence the impact on the Company’s business and operations include the duration and extent of the pandemic, the extent of containment and mitigation measures imposed or recommended, and the general economic consequences of the pandemic. . The pandemic could have a material adverse effect on the Company’s business, operations and financial results for an extended period.