LYON, France--(BUSINESS WIRE)--Jul. 12, 2017--
Regulatory News:
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris - ERYP), a
French clinical-stage biopharmaceutical company developing innovative
therapies for rare forms of cancer and orphan diseases, today announced
that it has entered into a research collaboration with Queen’s
University in Canada to advance the preclinical development of ERYTECH’s
eryminase program specifically for the treatment of arginase-1
deficiency, a rare and severe metabolic disorder related to arginine
metabolism. The collaboration will leverage the expertise of Queen’s
University and ERYTECH’s ERYCAPS platform technology with the goal of
generating in vivo proof-of-concept data in an arginase-1
deficiency animal model.
Arginase-1 deficiency is a rare, inherited disorder of the urea cycle
caused by a mutation in the arginase-1 gene, resulting in the
accumulation of toxic levels of the amino acid arginine in the blood.
Symptoms generally appear in early infancy and include intellectual
disability, non-ambulatory muscle stiffness and seizures. It is a
debilitating, progressive disease with very limited treatment options
currently available.
The collaboration between ERYTECH and Queen’s University aims to
demonstrate the potential of ERYTECH’s eryminase to lower arginine in
the inducible arginase-1 deficiency mouse model developed by the
laboratory of Prof. Colin Funk of Queen’s University. Eryminase, a
product candidate being developed by ERYTECH, consists of an arginine
deiminase enzyme encapsulated in red blood cells using ERYTECH’s
proprietary ERYCAPS platform technology. ERYTECH believes the
encapsulation of the therapeutic enzymes in the red blood cells can
provide effective, long-acting therapeutic activity with reduced
toxicity.
Prof. Colin Funk, PhD, Queen’s University, commented, “Arginase-1
deficiency is a severe, rare disorder affecting a biochemical pathway
that disposes of toxic ammonia. Normally, our bodies are very efficient
at removing any ammonia that accumulates after eating a protein-rich
meal. However, in patients with arginase-1 deficiency, the ammonia is
'partially detoxified' leading to a large accumulation of the amino acid
arginine in the patient’s blood and brain. ERYTECH’s product candidate
eryminase aims to reduce the level of arginine in blood and thus, has
significant potential to reduce negative consequences of this disorder.
We look forward to working with ERYTECH to advance their preclinical
program.”
Dr. Alexander Scheer, PhD, Chief Scientific Officer of ERYTECH,
added, “This is our second collaboration in the field of rare
metabolic diseases that underscores the scope of our platform and its
applicability to highly specialized and rare conditions beyond oncology.
We are very pleased to enter this collaboration with Queen’s University
and look forward to working closely on this important program with Dr.
Funk who specializes in research related to urea cycle disorders.”
About Queen’s University
Queen’s University is one of the leading research-intensive institutions
in Canada. The mission is to advance research excellence, leadership and
innovation, as well as enhance Queen’s impact at a national and
international level. Through undertaking leading-edge research, Queen’s
is addressing many of the world’s greatest challenges, and developing
innovative ideas and technological advances brought about by discoveries
in a variety of disciplines. Queen’s University is a member of the U15
Group of Canadian Research Universities.
About ERYTECH: 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’s
lead product candidate, eryaspase, also known under the trade name
GRASPA®, reported 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. A Phase 1 clinical study of
eryaspase is ongoing in the United States in adults with newly diagnosed
ALL, and a Phase 2b clinical study in Europe in elderly patients with
newly diagnosed AML, each in combination with chemotherapy.
The company believes that eryaspase also has potential as a treatment
approach in solid tumors. ERYTECH has successfully completed Phase 2b
clinical trial in France evaluating eryaspase in patients with
second-line metastatic pancreatic cancer.
Eryaspase 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.
The EMA and the U.S. Food and Drug Administration (FDA) have granted
orphan drug designations for eryaspase (GRASPA) for the treatment of
ALL, AML and 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.
In addition to eryaspase, ERYTECH is developing other product candidates
targeting cancer metabolism: erymethionase and eryminase, respectively
methionine-γ-lyase and arginine-deiminase encapsulated in red blood
cells. ERYTECH is exploring furthermore exploring the use of its
platform in immune-oncology (ERYMMUNE) and enzyme 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170711006643/en/
Source: ERYTECH Pharma
ERYTECH
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