ERYTECH Announces Abstract with Results from Eryaspase Phase 2 Trial in Acute Lymphoblastic Leukemia Selected for Oral Presentation at the American Society of Hematology 2020 Annual Meeting

Rhea-AI Summary

ERYTECH Pharma (Nasdaq & Euronext: ERYP) announced the selection of an abstract for an oral presentation at the 62nd American Society of Hematology Annual Meeting. This includes results from the NOPHO-sponsored Phase 2 trial of eryaspase in acute lymphoblastic leukemia (ALL) patients. The trial evaluated eryaspase's safety and efficacy for patients with hypersensitivity to pegylated asparaginase. Additionally, a second abstract concerning population pharmacokinetics of eryaspase in ALL and pancreatic adenocarcinoma patients will be featured as a poster presentation. Both presentations aim to demonstrate the potential of eryaspase in treating hemato-oncological conditions.

Positive

• Oral presentation selected for ASH meeting indicating recognition of eryaspase's potential.
• Phase 2 trial results suggest eryaspase's efficacy for ALL patients with hypersensitivity to existing treatments.

Negative

• None.

• Oral presentation to discuss findings from the Nordic Society of Paediatric Haematology and Oncology (NOPHO)-sponsored Phase 2 trial that confirm the potential of eryaspase as a treatment option for ALL
• Second abstract of new analysis supporting population pharmacokinetics of eryaspase in patients with ALL or pancreatic adenocarcinoma will also be presented

LYON, France and CAMBRIDGE, Mass. , Nov. 05, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announces that an abstract detailing results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients, has been selected for oral presentation at the upcoming 62^nd American Society of Hematology (ASH) Annual Meeting being held virtually December 5-8. A second abstract detailing population pharmacokinetics of eryaspase in ALL or pancreatic adenocarcinoma patients has been accepted for a poster presentation at the meeting.

Abstract #467: NOR-GRASPALL 2016 (NCT03267030): Asparaginase encapsulated in Erythrocytes (eryaspase) – a promising alternative to PEG-asparaginase in case of hypersensitivity

The NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The study findings will be featured as an oral presentation at ASH by Dr. Line Stensig Lynggaard, representing NOPHO, on 6^th December 2020 2.45pm PST/ 5.45pm EST / 11.45pm CET. Final results from this trial will be presented at the meeting.

The abstract can be found on-line at: https://ash.confex.com/ash/2020/webprogram/Paper139373.html

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

An analysis of the population pharmacokinetics (Pop PK) of eryaspase in patients with ALL or pancreatic adenocarcinoma (PAC) will be presented as a poster by Dr. Frank Hoke (ERYTECH’s Head of Clinical Pharmacology) on Monday 7^th December 2020 from 8am PST / 11am EST / 5pm CET. The analysis shows the extended circulation time of eryaspase, provides information on patient factors that influence the exposure of eryaspase, and evaluates patient population (PAC vs ALL) and formulation (native vs recombinant).

The abstract can be found on-line at: https://ash.confex.com/ash/2020/webprogram/Paper134377.html

“We are proud to be working with the NOPHO group and look forward to their presentation of new clinical data for the treatment of ALL at ASH this year. Alongside the POP PK analysis, the reporting of the NOPHO study represents significant progress towards our goal of finding a potential path forward with the FDA for eryaspase in ALL,” said Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer. “We believe that our science-driven approach to the development of eryaspase will provide a new option for people with ALL and, potentially, other haematological malignancies and solid tumours.”

Data included in the abstracts is based on data cut-offs in second quarter 2020. The final oral presentation and poster will include additional data collected between the abstract submission cut-off and the ASH congress.

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.

About ERYTECH and eryaspase

ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of 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 inside donor-derived red blood cells, targets the cancer cell’s altered asparagine and glutamine metabolism. 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. An investigator-sponsored Phase 2 study in acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.

ERYTECH produces its product candidates for 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 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.        
For more information, please visit www.erytech.com        

Forward-looking information

This press release contains forward-looking statements including but not limited to statements with respect to the clinical development plans of eryaspase; the potential indications for and benefits of eryaspase; statements relating to the TRYbeCA-1 clinical trial, including the timeline for patient enrollment as well as expected timing of the availability of results and interim superiority analysis; potential impacts on the Company’s clinical trials, including TRYbeCA-1 clinical trial, due to the coronavirus (COVID-19) pandemic such as delays in regulatory review, manufacturing and supply chain interruptions; and the overall impact of the COVID-19 pandemic on the global healthcare system as well as the Company’s business, financial condition and results of operations. 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. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results and timeline may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s Securities and Exchange Commission (SEC) filings and reports, including in the Company’s 2019 Document d’Enregistrement Universel filed with the AMF on March 18, 2020 and in the Company’s Annual Report on Form 20-F filed with the SEC on March 18, 2020 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak 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 any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse 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 is highly uncertain, and that 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 imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on the Company’s business, operations and financial results for an extended period of time.

CONTACTS

ERYTECH                      Eric Soyer CFO & COO	LifeSci 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 investors@ERYTECH.com	+1 (212) 915 - 2577 cdavis@lifesciadvisors.com	+33 1 44 71 94 94 ERYTECH@newcap.eu

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FAQ

What are the findings from the NOPHO-sponsored Phase 2 trial of eryaspase?

The findings demonstrate eryaspase's potential as a treatment option for acute lymphoblastic leukemia (ALL) patients with hypersensitivity to pegylated asparaginase.

When will the results of the eryaspase trial be presented?

The results will be presented orally at the ASH Annual Meeting on December 6, 2020.

What is the focus of the second abstract presented by ERYTECH?

The second abstract focuses on the population pharmacokinetics of eryaspase in patients with ALL and pancreatic adenocarcinoma.

How many patients were involved in the NOPHO Phase 2 trial of eryaspase?

The NOPHO Phase 2 trial enrolled 55 patients.

What is the significance of eryaspase in treating ALL?

Eryaspase may provide a new treatment avenue for ALL patients who experience hypersensitivity reactions to traditional asparaginase treatments, addressing a critical need.