LYON, France–(BUSINESS WIRE)– Regulatory News:
ERYTECH, het Franse biofarmaceutische bedrijf dat innovatieve behandelingen van acute leukemie en andere kankersoorten door middel van ‘uithongering’ van tumoren ontwikkelt, heeft vandaag bekendgemaakt dat het twee posterpresentaties geeft op de jaarlijkse bijeenkomst van de American Association for Cancer Research (AACR). De bijeenkomst vindt van 16 tot 20 april 2016 plaats in New Orleans.
ERYTECH presenteert zijn bevindingen in twee preklinische onderzoeken die zijn uitgevoerd om aan te tonen dan erythrocyten, of rode bloedcellen, effectieve dragers zijn voor het specifieke transport van ingekapselde therapeutische agenten voor effectievere behandelingen tegen kanker.
ERYTECH to Present Two Posters at AACR
LYON, France–(BUSINESS WIRE)– Regulatory News:
ERYTECH (Euronext Paris: FR0011471135 – ERYP) (ADR:EYRYY), a French biopharmaceutical company developing innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, today announced that it will present two posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting, being held April 16-20, 2016 in New Orleans, LA, USA.
ERYTECH will present its findings from two preclinical studies that are intended to demonstrate that erythrocytes, or red blood cells, are effective carriers to specifically transport and deliver encapsulated therapeutic agents for improved efficacy in cancer treatment.
The topline data and logistical details of the two posters to be presented include:
Abstract #2356 / Poster #11: Erythrocytes used as tumor antigen delivery system to target antigen-presenting cell embody an innovative approach for in situ cancer immunotherapy
Date: Monday, April 18, 2016
Time: 1:00 – 5:00 p.m. ET
Location: Section 27
The first poster, presented by Dr. Magali Cremel, Project Manager at ERYTECH, will discuss a preclinical study on the use of erythrocytes for immunotherapy. The study found that tumor antigens were efficiently encapsulated in erythrocytes in a dose-dependent manner. Researchers concluded that the use of erythrocytes as tumor antigen carriers to specifically deliver antigen to antigen-presenting cells and induce efficient immune response against tumors can be a very promising strategy in cancer immunotherapy.
Abstract #4812 / Poster #7: Arginine deiminase loaded in erythrocytes: a promising formulation for L-arginine deprivation therapy in cancers
Date: Wednesday, April 20, 2016
Time: 8:00 a.m. – 12:00 p.m. ET
Location: Section 20
The second poster, presented by Dr. Fabien Gay, Project Manager at ERYTECH, will discuss a preclinical study of arginine deiminase (ADI) enzyme-loaded erythrocytes as a promising alternative to improve the half-life and reduce the immunogenicity of ADI as a treatment for arginine-dependent cancers. Argininosuccinate synthase (ASS1) is the key enzyme in the synthesis of arginine and its expression varies in tumors, where ASS1 loss is associated with poor prognosis in different cancers, making it important to select ASS1-negative patients for arginine-depletion based enzymatic therapy. The study found that ERYTECH’s product candidate, ERY-ADI, reduced the plasma arginine level with no reported tolerability issues. Researchers concluded that arginine depletion through ADI treatment acts against ASS1-negative cancer cells in vitro and ERY-ADI may represent an innovative approach to improve efficacy for sustained arginine depletion and for the treatment of ASS1-deficient cancers.
About ERYTECH and ERY-ASP (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 treatment of blood cancers, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by depriving tumors of nutrients necessary for their survival. ERYTECH has recently filed for European Marketing Authorization for its lead product candidate, ERY-ASP, also known under the trade name GRASPA®, following positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of ERY-ASP in the United States in adults with newly diagnosed ALL, and a Phase 2b clinical trial in Europe in elderly patients with newly diagnosed AML, each in combination with chemotherapy.
ERY-ASP 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, from circulating blood plasma.
Every year over 50,000 patients in Europe and the United States are diagnosed with ALL or AML. For about 80% of these patients, mainly adults and relapsing patients, current forms of L-asparaginase cannot be used due to their toxicity or as a result of allergic reactions. ERYTECH believes that the safety and efficacy profile of ERY-ASP/GRASPA®, as observed in its Phase 2/3 pivotal clinical trial, offers an attractive alternative option for the treatment of leukemia patients.
ERYTECH believes that ERY-ASP has the potential as a treatment approach in solid tumors and is conducting a Phase 2 clinical trial in Europe in patients with metastatic pancreatic cancer. In addition to its current product candidates that focus on using encapsulated enzymes to induce tumor starvation, ERYTECH is exploring the use of its platform for developing cancer vaccines and enzyme replacement therapies.
The EMA and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for ERY-ASP/GRASPA for the treatment of ALL, AML and pancreatic cancer. ERYTECH produces ERY-ASP 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 ERY-ASP 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.
ERYTECH is listed on Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. ERYTECH is also listed in the U.S. under an ADR level 1 program (OTC, ticker EYRYY).
This document may contain forward-looking statements and estimates with respect to the financial position, results of operations, business strategy, plans, objectives 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. Documents filed by ERYTECH Pharma with the French Autorité des Marchés Financiers ( www.amf-france.org), also available on ERYTECH’s website ( www.erytech.com) describe such risks and uncertainties. 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 the publication of this document. 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.