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ERYTECH Announces Conference Webcast to Discuss Results from Eryaspase Phase 2 Trial in Acute Lymphoblastic Leukemia to be Presented at the American Society of Hematology 2020 Annual Meeting

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ERYTECH Pharma (Nasdaq & Euronext: ERYP) has announced a webcast on December 7 at 4:00 pm CET/10:00 am ET to discuss the results of the NOPHO Phase 2 trial for eryaspase in patients with Acute Lymphoblastic Leukemia (ALL). The trial involved 55 patients and aimed to evaluate the safety of eryaspase as a treatment alternative for those with hypersensitivity to PEG-asparaginase. The findings will be presented at the 62nd ASH Annual Meeting on December 6.

Positive
  • Webcast scheduled for December 7 to discuss Phase 2 trial results.
  • Eryaspase shows promise as an alternative treatment for patients with hypersensitivity to PEG-asparaginase.
  • The trial was conducted at 21 clinical sites across Nordic and Baltic countries.
Negative
  • Eryaspase is not yet approved in any country.
  • The uncertainty regarding the commercial success of eryaspase due to regulatory hurdles.

Webcast scheduled for Monday, December 7 at 4:00 pm CET/10:00 am ET

LYON, France and CAMBRIDGE, Mass., Dec. 03, 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 a webcast scheduled for investors to discuss the results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients.

The data will be presented by Dr. Line Stensig Lynggaard at the 62nd American Society of Hematology (ASH) Annual Meeting. On the webcast, 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.

Oral Presentation Details (accessible only if registered for the ASH annual 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 6th 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

Webcast Details

ERYTECH will hold a webcast on 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: https://edge.media-server.com/mmc/p/yp9nynh6.

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.

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 was recently completed in the Nordic countries of Europe. Eryaspase is not approved in any country.

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

PDF available at: http://ml.globenewswire.com/Resource/Download/a076b04e-4b8a-4e48-88e7-06570c97b315


FAQ

What are the results of the NOPHO Phase 2 trial of eryaspase?

The trial evaluated eryaspase for ALL patients with hypersensitivity to PEG-asparaginase, involving 55 participants.

When is the webcast about eryaspase scheduled?

The webcast is scheduled for December 7, 2020, at 4:00 pm CET/10:00 am ET.

Where will the Phase 2 trial results be presented?

The results will be presented at the 62nd ASH Annual Meeting on December 6, 2020.

What is the significance of eryaspase for ALL patients?

Eryaspase may serve as a treatment alternative for patients who experience hypersensitivity reactions to standard PEG-asparaginase.

Is eryaspase approved for use in any countries?

Currently, eryaspase is not approved in any country.

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