ERYTECH to Present Results from Phase I Trial of eryaspase in ALL and New Pre-clinical Data at AACR 2018
ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will present full results from its U.S. Phase I trial evaluating eryaspase (GRASPA ® ) in combination with chemotherapy for the treatment of acute lymphoblastic leukemia (ALL) and pre-clinical data on the erymethionase program at the upcoming American Association for Cancer Research Annual Meeting, being held April 14-18, 2018 in Chicago, Illinois.
The U.S. Phase I ALL data will be presented during the poster session of the Phase I clinical trials by the lead author of the abstract, Dr. Alison Walker. The data from the dose-escalating Phase I clinical study demonstrate that eryaspase, L-asparaginase encapsulated in red blood cells, was well-tolerated when combined with CALGB 8811 protocol for frontline treatment of adults with ALL. Based on the PK data and the safety findings, the recommended dose for further clinical development is determined at 100 U/kg.
ERYTECH will also present pre-clinical data on the combination of eryaspase and erymethionase, methionine-gamma-lyase encapsulated in red blood cells, at a poster session on Wednesday, April 18, which show promising in vitro and in vivo bi-therapy therapeutic efficacy in different cancer models.
Poster Session: A Phase I study of eryaspase (L-asparaginase encapsulated in red blood cells) in combination with induction and consolidation chemotherapy for adult patients with newly diagnosed acute lymphoblastic leukemia (ALL)
|#CT023 / 16|
|Dr. Alison Walker|
|PO.CT01 - Phase I Clinical Trials 1|
|Sunday, April 15|
|1:00 p.m. – 5:00 p.m.|
Poster Session: Enzymatic combination investigation in cancer therapy
|#5827 / 23|
|PO.ET01.04 - Combination Chemotherapy 2|
|Wednesday, April 18|
|8:00 AM – 12:00 PM|
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The Company’s lead product, eryaspase, also known under the trade name GRASPA®, consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
ERYTECH produces eryaspase at its own GMP-approved and operational manufacturing site in Lyon (France), and at a site for clinical production in Philadelphia (USA). ERYTECH has entered into licensing and distribution partnership agreements for eryaspase for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, which will market the product under the GRASPA® brand name. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for eryaspase for the treatment of ALL, AML and pancreatic cancer.
In addition to eryaspase, ERYTECH is developing erymethionase, methionine-γ-lyase encapsulated in red blood cells, to target cancer cells’ amino acid metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
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.
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy, and anticipated future performance of ERYTECH and of the market in which it operates. 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. They include all matters that are not historical facts. 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 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, the Company’s Securities and Exchange Commission filings and reports, including in the Company’s prospectus filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, on November 13, 2017 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.
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
+33 1 44 71 98 52
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Cushman & Wakefield To Acquire Its Irish Affiliate From Sherry FitzGerald Group16.7.2018 13:49 | Pressemelding
Global real estate services firm Cushman & Wakefield today announces it has entered into a definitive agreement to acquire the commercial property arm of Sherry FitzGerald Group in the Republic of Ireland. The deal is expected to complete in early September 2018. Cushman & Wakefield already has a 20% stake in the Irish commercial property business which operated as its exclusive affiliate in the Republic – rebranding two years ago as Cushman & Wakefield Ireland. The firm, which has more than 100 commercial property professionals and offices in Dublin, Limerick and Galway, will now be fully integrated into Cushman & Wakefield, one of the world’s largest real estate services firms with 48,000 employees in approximately 400 offices and 70 countries. Managing Director Aidan Gavin becomes Cushman & Wakefield’s Head of Ireland and will also sit on the firm’s UK & Ireland Executive Committee. Cushman & Wakefield will maintain its close affiliate relationship with the wider Sherry FitzGerald G
Fischer & Schickendantz and Solution Alliance SRL Adopt Andersen Brand in Uruguay16.7.2018 13:30 | Pressemelding
Fischer & Schickendantz, led by Juan Federico Fischer, and Solution Alliance SRL, led by Juan Ignacio Troccoli, have rebranded this week as Andersen Tax & Legal, a member firm of Andersen Global. The firm, based in Montevideo, entered a Collaboration Agreement with Andersen Global in September 2017, and is now a fully integrated member of the global verein. Juan Federico Fischer remarked, “Andersen is a symbol of quality and is recognized worldwide by both clients and professionals, and is ahead of the game in terms of creating a global firm with integrated tax and legal services. We are truly excited to officially be part of the team.” “Throughout their time with us as a collaborating firm and now a member firm, the team in Uruguay has demonstrated a deep commitment to providing seamless, best-in-class service. Additionally, Juan Federico is a member of Andersen Global’s Latin American regional board, and is the true embodiment of the values that our organization represents. I look fo
Norsk Titanium Produces Space Demonstration Hardware16.7.2018 11:00 | Pressemelding
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, has produced an Expansion Nozzle demonstrator in support of the European Space Agency’s Technology Research Programme (TRP). The TRP is an European Space Agency (ESA) technology development effort supporting all of ESA’s fields of activity across the entire spectrum of technical disciplines, providing the technological nucleus for most future developments. Norsk was awarded a TRP contract with the ESA in 2014 to explore the application of Norsk’s Rapid Plasma Deposition™ (RPD™) process to space applications. Through the TRP contract, Norsk has refined its material characterization and quality assurance processes, while providing ESA valuable insight into the application of additive processes to their unique needs. The culmination of this effort was the production of an Expansion Nozzle demonstrator. The Expansion Nozzle utilizes the latest RPD™ desi
CALVIN KLEIN Fragrances Announces Lupita Nyong'o and Saoirse Ronan as Faces of CALVIN KLEIN WOMEN16.7.2018 11:00 | Pressemelding
Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE:PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE:COTY], today revealed the worldwide print advertising campaign for the new fragrance CALVIN KLEIN WOMEN , the first CALVIN KLEIN fragrance to be developed under the vision of Chief Creative Officer, Raf Simons. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005092/en/ CALVIN KLEIN WOMEN The campaign features Lupita Nyong'o and Saoirse Ronan. Award-winning actors and voices of their generation, both women are universally recognized for their unique talent, creativity, intelligence and strength of character. Directed by artist Anne Collier with creative direction from Lloyd & Co., the campaign champions iconic women and celebrates heroines of contemporary culture. Lupita and Saoirse are featured in the print campaign, in a pair of striking and direct portraits, positioned next to chosen figure
Bank of America Reports Second-Quarter 2018 Financial Results16.7.2018 10:45 | Pressemelding
Bank of America reported its second-quarter 2018 financial results today. The news release, supplemental filing and investor presentation can be accessed in the following ways: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005280/en/ Bank of America newsroom at https://newsroom.bankofamerica.com Bank of America Investor Relations website at http://investor.bankofamerica.com Business Wire’s news webpage at http://www.businesswire.com/portal/site/home/news Investor Conference Call information Chief Executive Officer Brian Moynihan and Chief Financial Officer Paul Donofrio will discuss the financial results in a conference call at 8:30 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international), and the conference ID is 79795. Please dial in 10 minutes prior to the start of the call. Investors can also listen to a live audio webcast of the conference ca
Bank of Singapore is the First Singapore Private Bank to Receive Regulatory Approval to Open a Wealth Management Subsidiary in Luxembourg16.7.2018 09:36 | Pressemelding
Bank of Singapore today announced that it has been granted an investment company licence to operate a wealth management subsidiary in Luxembourg – a first for a Singapore private bank. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005252/en/ (Photo: BOSWM) Bank of Singapore, through this new subsidiary, BOS Wealth Management Europe Société Anonyme (S.A.), will be able to offer a comprehensive range of customised private banking solutions and investment advisory services to its ultra-high and high net worth clients in the European Economic Area (“EEA”) and the United Kingdom (“UK”). The EEA comprises the European Union (EU) countries and Iceland, Liechtenstein and Norway. Currently, Bank of Singapore serves its European clients from its Singapore headquarters and through its parent company OCBC Bank’s London office. There has been robust growth in assets under management from EEA clients as they hold Singapore in high