DGAP-News: ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase (GRASPA(R)) for Pancreatic Cancer


DGAP-News: ERYTECH PHARMA SA / Key word(s): Study
ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase
(GRASPA(R)) for Pancreatic Cancer

26.09.2016 / 10:38
The issuer is solely responsible for the content of this announcement.

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ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase
(GRASPA(R)) for Pancreatic Cancer

Primary data read-out from the trial expected by early 2017

Lyon (France), September 26, 2016 - ERYTECH Pharma (Euronext Paris: ERYP),
a French biopharmaceutical company developing 'tumor starvation' treatments
for acute leukemia and other oncology indications with unmet medical needs,
today announced the final patient has been enrolled in its Phase 2 trial of
eryaspase, also known as ERY-ASP or GRASPA(R), for the treatment of
pancreatic cancer.

The multicenter, randomized Phase 2 trial is evaluating eryaspase as a
second-line treatment of patients with metastatic pancreatic cancer. In the
study conducted in France, eryaspase was added to the standard of care
(currently Gemcitabine or FOLFOX regimen) and then compared to the standard
of care alone in a 2-to-1 randomization. The primary endpoint of the trial
is progression-free survival (PFS) at four months.

The trial has completed enrollment of 139 patients and we expect to report
primary results from this trial by early 2017.

"The Phase 2 trial of eryaspase for pancreatic cancer is, to our knowledge,
the largest cohort of solid tumor patients treated with an asparaginase-
based product to date," said Gil Beyen, Chairman and CEO of ERYTECH.
"Previously, deprivation of asparagine has shown to limit growth of
pancreatic and other solid tumors in preclinical models, but clinical proof
of concept has not yet been established. We believe a positive efficacy
signal in this trial could open a potentially large application area for
asparagine depletion in certain solid tumors."

About pancreatic cancer:

Pancreatic cancer is a disease in which malignant (cancer) cells are found
in the tissues of the pancreas. Every year there are about 150,000 new
cases of pancreatic cancer diagnosed in Europe and the United States.
Pancreatic cancer is a particularly aggressive cancer, with a five-year
survival rate of less than 10% and is currently the fourth most common
cause of cancer death in the EU for men and women. Pancreatic cancer could
be a suitable indication for eryaspase because it involves a large
proportion of tumors that are believed to be sensitive to asparagine
depletion, allowing it to potentially have an impact.

About ERYTECH and ERY-ASP (GRASPA(R)): 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,
eryaspase, also known as ERY-ASP or under the trade name GRASPA(R),
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
eryaspase 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.

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. Every year over 50,000 patients in
Europe and the United States are diagnosed with ALL or 2

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 eryaspase (GRASPA(R)), as observed in its Phase 2/3
pivotal clinical trial, offers an attractive alternative option for the
treatment of leukemia patients.

ERYTECH believes that eryaspase 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 eryaspase 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(R) 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).

CONTACTS

<pre>

ERYTECH                    The Ruth Group            NewCap
Gil Beyen                  Lee Roth                  Julien Perez
Chairman and CEO           Investor relations        Investor relations
Eric Soyer                 Kirsten Thomas            Nicolas Merigeau
CFO and COO                Media relations           Media relations
+33 4 78 74 44 38          +1 646 536 7012           +33 1 44 71 98 52
investors@erytech.com      lroth@theruthgroup.com    erytech@newcap.eu
                           +1 508 280 6592
                           kthomas@theruthgroup.com


</pre>

Forward-looking information

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.


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505389 26.09.2016