Business Wire

ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL

Jaa

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the determination of the recommended pivotal Phase 3 dosing from its U.S. Phase 1 dose escalation study with eryaspase (GRASPA®) in first line treatment of adult ALL patients.

The U.S. Phase 1 study with eryaspase (GRASPA) is an open label dose escalation study evaluating the safety of eryaspase in combination with CALGB 8811 protocol for first line treatment of adult ALL patients. The study is performed at five clinical sites across the United States. Prof. Dr. Richard Larson, director of the Hematologic Malignancies Clinical Research Program at the University of Chicago, is the principal investigator of the study.

ERYTECH recently announced that all patients had been treated in the third dose escalation cohort of this Phase 1 study. The steering committee of the study reviewed the safety data of all three treatment cohorts and agreed to pursue further development at the dose level of 100 U/kg. This dose level had been previously recommended following ERYTECH’s Phase 2 study in elderly ALL patients. It is also the dose level used in the Phase 2b study in second line, metastatic pancreatic cancer, that recently reported positive efficacy and safety results, and in the ongoing Phase 2b study in AML, from which top-line results are expected by the end of this year.

In parallel with running an expansion cohort of this Phase 1 study at this recommended dose, ERYTECH will potentially initiate the steps toward the launch of a pivotal Phase 3 study in first line adult ALL patients at this dose level.

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 amino acid metabolism of cancer, 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 acute lymphoblastic leukemia (ALL), but side effects limit treatment, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.

Eryaspase achieved positive efficacy and safety results in a Phase 2 study in elderly patients with ALL, and a Phase 2/3 study in children and adults with relapsed or refractory ALL. ERYTECH believes that the positive results of its Phase 2b clinical study in second-line metastatic pancreatic cancer are significant indicators of eryaspase as a potential treatment approach in solid tumors. ERYTECH also has an ongoing Phase 1 clinical study of eryaspase in the United States in adults with newly diagnosed ALL and a Phase 2b clinical study in Europe in elderly patients with newly diagnosed acute myeloid leukemia (AML), each in combination with chemotherapy.

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 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).

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, 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.

Contact information

ERYTECH
Naomi Eichenbaum
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
The Ruth Group
Lee Roth
Investor relations
+1 646 536 7012
lroth@theruthgroup.com
or
Kirsten Thomas
Media relations
+1 508 280 6592
kthomas@theruthgroup.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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

E Ink and LTS Partner to Develop Smart Patch to Improve Medical Management23.10.2017 10:00Tiedote

E Ink Holdings, "E Ink" (8069.TW), the leading innovator of electronic ink technology and LTS Lohmann-Therapie Systeme AG, “LTS” leading in the development and manufacturing of transdermal therapeutic systems, today announced their partnership to develop a “Smart Patch” prototype. The Smart Patch prototype is a transdermal therapeutic system (TTS) that delivers medication to patients in a convenient, controlled and comfortable manner and features an E Ink display to deliver and convey relevant information about patch performance. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023005449/en/ The “Smart Patch” prototype features an E Ink display to convey relevant information about patch performance to patients. (Photo: E Ink Holdings) According to a report conducted by the New England Healthcare Institute

MaxLinear and Corinex to Use G.hn for Open Smart Metering Solution23.10.2017 09:00Tiedote

MaxLinear, Inc. (NYSE:MXL), a leading provider of radio frequency (RF), analog and mixed-signal integrated circuits for the connected home, wired and wireless infrastructure, and industrial and multimarket applications and Corinex, a unique supplier of broadband solutions (BPL) for smart metering and smart grid infrastructure improving grid operational efficiency, security and integration of renewable energy and EV’s today announced that they will cooperate to create a broadband utility infrastructure solution based on standard ITU-T G.hn technology to enable smart metering and other smart grid applications. The G.hn solution will address the growing interest of electricity utilities in leveraging broadband powerline networks for Smart Grid applications, while ensuring multi-vendor interoperability, openness and easy integration into a wide range of Smart Meters and Smart Grid infrastr

NTT Communications to Share Industry Views with Global Carrier Community at Capacity Europe 2017 in London23.10.2017 09:00Tiedote

Executives from NTT Communications (NTT Com), the global data and IP services arm of Fortune Global 500 telecom leader NTT (TYO: 9432), will play a prominent speaking role at this year’s Capacity Europe conference in London – Europe’s largest annual meeting for the global carrier community. During the conference, which runs October 24-26 at the Intercontinental London 02, NTT Com executives will participate in three panels that provide expert analysis and perspective on trending industry topics including the Internet of Things (IoT), network security and the importance of innovation and leadership. NTT Com is in a unique position to address global wholesale trends and opportunities as the global carrier consistently ranks as one of the top IP network providers worldwide. “Coming together as an industry to share insights and perspective is not only beneficia

ADC Therapeutics Announces Closing of $200 Million Private Financing to Fund Two Lead Programs Through Registrational Trials23.10.2017 07:55Tiedote

ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced that it has raised $200 million through a private placement. The financing was oversubscribed and supported by both existing and new investors, including Auven Therapeutics, Redmile, the Wild Family Office and AstraZeneca. The proceeds will be used to progress ADCT-301 and ADCT-402 into planned registrational trials in 2018. Both candidates are currently in four clinical studies in important sub-types of lymphoma and leukemia. ADCT will also advance ADCT-301 into a combination study for solid tumors. Further it will allow the Company to continue the development of the Phase I study of ADCT-502 in patients with advanced solid tumors with HER2 expression, to file INDs for ADCT-602 and ADCT-6

Mitsui Chemicals Tohcello, Inc. Establishes a New Company in Taiwan23.10.2017 05:00Tiedote

Mitsui Chemicals, Inc. (Head Office: Minato-ku, Tokyo; President & CEO: Tsutomu Tannowa) announced that its wholly owned subsidiary, Mitsui Chemicals Tohcello, Inc. (Head Office: Chiyoda-ku, Tokyo; President & CEO: Yoshihisa Fujimaki) has decided to establish a company in Taiwan that will manufacture and sell the ICROS™Tape, a tape for semiconductor manufacturing. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171022005001/en/ ICROS(TM)Tape (Photo: Business Wire) The ICROS™Tape is a protective tape used for semiconductor manufacturing. It holds the world’s largest market share as a protective tape for the back grinding process of silicon wafer. The semiconductor market is experiencing growing demand attributable in part to the growth of mobile terminals. Demand is expected to continue to grow a

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201721.10.2017 00:00Tiedote

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

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