ERYTECH Requested a Pre-BLA Meeting with the FDA to Discuss Path to Approval in ALL Paris Stock Exchange:ERYP

ERYTECH Requested a Pre-BLA meeting with the FDA
to discuss the path to approval in ALL

ERYTECH Invited by FDA to Request Pre-BLA Meeting F.first step in the marketing approval method with the FDA for eryaspase for the treatment of hypersensitive ALL patients based on the positive results of the NOPHO sponsored phase 2 clinical trial

Lyon (France) and Cambridge, MA (USA), April 20 2021 ERYTECH Pharma (Nasdaq and Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances in red blood cells, today to announced the initiatedion of the process of searching marketing approval from the US Food and Drug Administration (US FDA) for its main product candidate eryaspase in patients with acute lymphocytic leukemia (ALL) that have evolved hypersensitivity responses to PIN-asparaginase based on the positive results of the NOPHO-sposited Phase 2 clinical trial

Maintaining adequate asparaginase treatment after PEG asparaginase hypersensitivity is an important goal in the management of patients with ALL. A global shortage of Erwinia-derived asparaginase, the current alternative treatment option for PEG asparaginase, highlights the need for alternative treatment options for these patients.

Results from the NOPHO sponsored Phase 2 clinical trial showed that eryaspase in combination with chemotherapy, administered every two weeks, provides sustained asparaginase enzyme activity and is generally well tolerated with few hypersensitivity reactions. The study results were presented at the 62nd ASH annual meeting in December 2020. The researchers positioned eryaspase as a potentially attractive treatment option for patients who developed hypersensitivity to PEG-asparaginase.

ERYTECH initiated a dialogue with the US FDA in 2020 to evaluate the potential of eryaspase to be approved for the treatment of hypersensitive ALL patients based on the NOPHO-sponsored Phase 2 clinical trial. The FDA confirmed the unmet medical need and, after reviewing a comprehensive data package submitted by ERYTECH, the company invited the company to request a pre-BLA meeting to explore the potential of the NOPHO-sponsored Phase 2 clinical discuss a study in support of marketing approval in the United States.

ERYTECH has requested a pre-BLA meeting and depending on the feedback received at that meeting, the company plans to submit a biological license application (BLA) for its lead product candidate eryaspase for the treatment of hypersensitive ALL patients.

About the NOPHO study (NOR-GRASPALL-2016)

The NOPHO sponsored Phase 2 clinical trial (NOR-GRASPALL-2016) evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously had hypersensitivity reactions to pegylated asparaginase treatment. The study 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 55 patients were enrolled. The primary objectives of the study were the activity and safety of asparaginase enzyme. Both endpoints are met.

in the study, eryaspase showed sustained asparaginase enzyme activity above the threshold of> 100 U / L at trough levels 14 days after the first infusion in 54 of 55 treated patients. 96% of the patients were able to complete the intended asparaginase treatment.

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 had a severe allergic reaction and withdrew from eryaspase treatment.

About acute lymphocytic leukemia

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

About ERYTECH and eryaspase

ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell drugs for severe cancers and orphan diseases. Using its proprietary ERYCAPS® platform, which uses a new technology to encapsulate drug substances in red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is to develop product candidates that target the altered metabolism of cancer cells by depriving them of 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 altered asparagine and glutamine metabolism of the cancer cell. Eryaspase is in phase 3 clinical development for the treatment of second-line pancreatic cancer and in phase 2 for the treatment of first-line triple negative breast cancer. A phase 2 investigator-sponsored clinical trial in patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to PEG asparaginase was recently completed in the Nordic countries of Europe. Eryaspase is currently not approved in any country.

ERYTECH manufactures its candidate products 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.

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 the 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

Forward-Looking Information

This press release contains forward-looking statements, including, but not limited to, statements regarding eryaspase’s clinical development and regulatory plans, including the Company’s anticipated timing for filing a BLA, the Company’s ability to obtain regulatory approval. Obtain agencies for the treatment of patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to PEG-asparaginase and the company’s expectations regarding alternative markets for hypersensitive ALL patients. Certain of these statements, predictions, and estimates may be identified by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates” , “May”, “will” and “continue” and similar expressions. Such 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 when they were made, but which may or may not prove to be correct. Actual events are difficult to predict and may depend on factors outside ERYTECH’s control. No assurances can be made with respect to product candidates in the pipeline that the candidates will receive the necessary regulatory approvals or that they will prove commercially successful. Therefore, actual results and timeline may differ materially from expected future results, performance or performance expressed or implied by such statements, forecasts and estimates. A further description of these risks, uncertainties and other risks can be found in the Company’s regulated filings with the French Autorité des Marchés Financiers (AMF), the filings and reports of the Company’s Securities and Exchange Commission (SEC), including in the 2020 Document d ‘Universal Submission 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 filings and reports by the company. Given these uncertainties, no statements are made as to the accuracy or reasonableness of such forward-looking statements, forecasts and estimates. In addition, 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 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 with respect thereto, or any change in events, circumstances or circumstances on which any such statement, prediction or estimate is based, except to the degree required by law. In addition, the COVID-19 pandemic and associated containment efforts have had serious adverse effects on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The magnitude and duration of the impact on the Company’s business and operations is highly uncertain, and that impact includes effects on clinical trial operations and the supply chain. Factors that will affect the impact on the Company’s business and operations include the duration and magnitude of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic impact of the pandemic. The pandemic could have a material adverse effect on the Company’s business, operations and financial results over an extended period of time.

CONTACTS

ERYTECH
Eric Soyer
CFO and COOLifeSci Advisors, LLC
Investor Relations
Corey Davis, Ph.D.NewCap
Mathilde Bohin /
Louis-Victor Delouvrier
Investor Relations
Nicolas Merigeau
Media relations

+33 4 78 74 44 38
[email protected]

+1 (212) 915-2577
[email protected]

+33 1 44 71 94 94
[email protected]

ERYTECH_PR_pre-BLA_ALL – FINAL 2

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