Business Wire

ERYTECH to Present Results from Phase I Trial of eryaspase in ALL and New Pre-clinical Data at AACR 2018

Jaa

Regulatory News:

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)

Poster:

    #CT023 / 16

Lead Author:

Dr. Alison Walker

Poster Session/Section:

PO.CT01 - Phase I Clinical Trials 1

Date:

Sunday, April 15

Time:

1:00 p.m. – 5:00 p.m.
 
 

Poster Session: Enzymatic combination investigation in cancer therapy

 

Poster:

#5827 / 23

Lead Author:

Karine Aguera

Poster Session/Section:

PO.ET01.04 - Combination Chemotherapy 2

Date:

Wednesday, April 18

Time:

8:00 AM – 12:00 PM
 

Abstracts are available on the AACR website. The two posters are to be presented at the 2018 AACR Annual Meeting and will be available on the Erytech website after April 18, 2018.

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.

Forward-looking information

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.

Contact information

ERYTECH
Naomi Eichenbaum
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
NewCap
Julien Perez
Investor relations
Nicolas Merigeau
Media relations
+33 1 44 71 98 52
erytech@newcap.eu

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Quadient Announces General Availability of Quadient Inspire R1225.6.2018 17:30Tiedote

www.quadient.com : Quadient, the award-winning leader in Customer Communications Management (CCM), announced the general availability of its newest release, Quadient Inspire R12, which includes the new Digital Advantage Suite. The updated version of Quadient Inspire is designed to give customers and partners greater control over the systems and processes used to drive consistent communications across all channels with an emphasis on digital experiences. With Inspire R12, users design omni-channel communications in days rather than months with a simple, modern and comprehensive platform. The solution makes it possible to change designs and test for all channels in minutes, with fully integrated tracking and approval processes built in. Additionally, R12 integrates all parts of the communications process from linking journey maps to communications, postal sorting, address, phone and email verifications, email delivery, SMS delivery, mail delivery tracking, and production monitoring to re

The Dementia Discovery Fund Raises $350 Million25.6.2018 16:00Tiedote

The Dementia Discovery Fund (DDF) today announces the completion of its fundraising, with £250 million ($350 million at the time of completion) raised from an influential group of strategic investors committed to developing new medicines for dementia. The goal was met today with a new investment of $60 million from US AARP, the global nonpartisan organisation dedicated to empowering Americans 50 and older to choose how they live as they age. The fundraising far exceeded its initial target of $200 million (£130 million), making it the first and largest venture fund focused entirely on discovering and developing novel therapies for dementia, including Alzheimer’s disease. The DDF makes early stage venture capital investments to develop novel disease-modifying therapeutics for all forms of dementia. The fund is managed by SV Health and was formed through the collaboration of leading pharmaceutical companies (Biogen, Eli Lilly and Company, GSK, Johnson & Johnson, Otsuka (Astex), Pfizer and

Professor Thierry Philip Takes Office as OECI President25.6.2018 15:22Tiedote

Professor Thierry Philip, President of the Institut Curie, has been elected President of the Organisation of European Cancer Institutes ( OECI ) for a three-year term. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005600/en/ Pr Thierry Philip (Photo: Business Wire) At the end of June 2018, Professor Philip, an oncologist and pediatrician, will take over as head of this European organization, which brings together 90 institutes and university centers and whose mission is fully devoted to cancer. This European non-governmental, non-profit organization aims to promote cooperation between its members or associate members and pursues a triple objective: to provide cancer patients in Europe with equal access to high-quality care; to assist European institutes with the implementation of a quality system for oncology care; to promote and accelerate the progress of translational research. In this regard, half of the 90 OECI ce

Boehringer Ingelheim and Lilly announce positive top-line Phase III data results for empagliflozin as adjunct to insulin in type 1 diabetes25.6.2018 15:07Tiedote

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that both randomised controlled trials in the EASE phase III programme, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in HbA1c after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10, and 25 mg). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005579/en/ Type 1 diabetes currently affects approximately 30 million adults worldwide.1 It is an autoimmune disease in which the body does not produce sufficient amounts of insulin and therefore requires life-long daily insulin administration to regulate blood sugar. For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. People with type

European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection25.6.2018 15:03Tiedote

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years. In Europe, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. No dosage adjustment of BIC/FTC/TAF is required in patien

AlipayHK and GCash Launch Cross-Border Remittance Service Powered by Alipay’s Blockchain Technology25.6.2018 15:00Tiedote

AlipayHK and GCash today announced the launch of a cross-border remittance service through their e-wallet platforms, powered by cutting-edge blockchain technology developed by Alipay, the online payment platform operated by Ant Financial Services Group (“Ant Financial”, “Ant”). This is the first blockchain-based cross-border digital wallet remittance service globally, offering a fast, secure, convenient, transparent and low-cost way to transfer money directly between individuals in Hong Kong and the Philippines. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005561/en/ Mary Grace (left), who has been working in HK for 22 years, demonstrated how it took her 3 seconds to transfer money to her family back in the Philippines, through the mobile payment app AlipayHK (Photo: Business Wire) Alipay has applied blockchain technology to streamline the remittance process, radically improving the speed of delivery, enhancing trans

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme