ERYTECH Selects Triple Negative Breast Cancer as Next Indication for Eryaspase
ERYTECH Pharma (Euronext: ERYP- Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the selection of Triple Negative Breast Cancer as the next target indication for broadening the scope of eryaspase (GRASPA®) development in solid tumors.
L-asparaginase is a cornerstone treatment in acute lymphoblastic leukemia (ALL), especially for pediatric patients, but the excessive toxicity of conventional L-asparaginase formulations has limited its use in other indications.
The positive Phase 2b result of eryaspase (L-asparaginase encapsulated in red blood cells) in metastatic pancreatic cancer, reported in 2017, represents, to our knowledge, the first-ever evidence of clinical benefit of an asparaginase-based product in a solid tumor indication. In this 141-patient randomized Phase 2b study, eryaspase in combination with chemotherapy demonstrated a 40% reduction in risk of death rate (HR=0.60; p=0.009) compared to chemotherapy alone.
Following these very encouraging results, ERYTECH conducted a comprehensive evaluation to determine other potential solid-tumor indications for developing eryaspase. Metastatic Triple-Negative Breast Cancer (TNBC) has now been selected as the next indication to expand the potential use of eryaspase in solid tumors. TNBC is an aggressive and metabolically active form of breast cancer with high rates of symptomatic metastases. A recent publication in Nature1 supports the hypothesis that restricting availability of asparagine can reduce metastatic progression of cancer cells in breast cancer. One of the most striking observations from our Phase 2b trial in pancreatic cancer was the 40% reduction of new lesions in the eryaspase arm compared to the control arm.
“TNBC is a heterogenous subgroup of breast cancer associated with poor patient outcome and high risk of recurrence compared to other breast cancer subtypes. Aside from BRCA1/2 mutation status, treatment options for TNBC remain limited,” commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH. “There is growing evidence of altered metabolism in TNBC. The evaluation of eryaspase in metastatic TNBC provides a promising new therapeutic approach, which capitalizes on reprogramming of the metabolic pathways in this disease.”
Gil Beyen, Chairman and CEO of ERYTECH, added, “The selection of TNBC as the second solid tumor indication for evaluating eryaspase anti-tumor activity brings hope for improving the health of these women. The safety profile of eryaspase provides additional rationale for combination with currently existing therapies to increase treatment options in TNBC.”
The development in TNBC complements ERYTECH’s pipeline of programs, which focus on the development of therapies that target amino acid metabolism of tumor cells. Set-up activities of a Phase 2 proof-of-concept clinical study have started and ERYTECH expects to enroll the first patient in Q3 2018.
About Triple-Negative Breast Cancer (TNBC)
Breast cancer is the most commonly diagnosed cancer in women globally with nearly 1.8 million new cases diagnosed annually2. It is estimated that over 600,000 women each year are diagnosed with breast cancer in the United States and Europe in aggregate3. Approximately 10-20% of breast cancers are TNBC, a form of breast cancer that lacks expression of estrogen receptor (ER), progesterone receptor (PR) and does not overexpress HER24. TNBC is associated with a poorer prognosis when compared to other breast cancer subtypes. As commonly utilized hormone therapy and HER2 targeting agents are not treatment options for women with TNBC, there is significant unmet need for novel therapeutic approaches in this subtype of breast cancer.
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 study in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b study of second-line treatment of patients with metastatic pancreatic 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 two other product candidates, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer 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). ERYTECH 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. 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 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.
|Knott et al., Nature, Februari 2018|
|2||World Health Organization (International Agency for Research on Cancer), Globocan 2012|
|3||Cancer Facts and Figures, 2018 (American Cancer Society)|
|4||Yam C et al., The Oncologist, September 2017|
Director of Investor Relations
+33 4 78 74 44 38
The Ruth Group
Lee Roth, +1 646-536-7012
Kirsten Thomas, +1 508-280-6592
+33 1 44 71 98 52
Investor relations - Julien Perez
Media relations - Nicolas Merigeau
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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Summer Business with Yourtyres.co.uk: New Shop Feature and High-Performance Tyre Models16.3.2018 17:11 | Tiedote
Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time, Yourtyres.co.uk, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at Yourtyres.co.uk. When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of Yourtyres.co.uk simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005448/en/ An advice mode immediately helps trade customers use the full pot
Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 15:00 | Tiedote
Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on Samsung.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005175/en/ Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on Samsung.com. (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum
AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 12:00 | Tiedote
AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005010/en/ AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ
CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 12:00 | Tiedote
Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005030/en/ Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential
Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 11:45 | Tiedote
Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power
Lighting Manufacturer LTS Licht & Leuchten, Part of the Fargerhult Group, to Offer Selected Spot- & Downlights with Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs16.3.2018 11:02 | Tiedote
Seoul Semiconductor, a global innovator of LED products and technology, announced that its SunLike Series natural spectrum LEDs, which implement light closest to the spectrum of natural sunlight, has been adopted for selected luminaires of LTS Licht & Leuchten GmbH, a German manufacturer of high-quality luminaires for hospitality, retail, and office applications. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005206/en/ LTS Jett 100 spotlights equipped with SunLike LED technology (Photo: Business Wire) LTS has adopted SunLike natural spectrum LEDs for selected products, including the Jett 100 and CSA 60 spotlights. A series of spotlights with a discreet and individual appearance, and clear, straightforward design lines, Jett spotlights harmoniously blend in with any type of retail application. The high color rendering and superior luminous intensity of these spotlights enable lighting designers to achieve accentuated ar
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