- Investigational New Drug Application reviewed and
accepted
- Enrollment
of US patients expected to begin in Q3 2019
- Clinical
trial authorizations now obtained in all twelve participating
countries
LYON, France and CAMBRIDGE, Mass.
, May 13, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a
clinical-stage biopharmaceutical company developing innovative
therapies by encapsulating drug substances inside red blood cells,
today announced the acceptance by the US Food and Drug
Administration (FDA) of its Investigational New Drug (IND)
application for eryaspase, consisting of the enzyme L-asparaginase
encapsulated inside donor derived red blood cells. The
acceptance of the IND will enable ERYTECH to initiate enrollment at
US trial sites for its ongoing pivotal Phase 3 TRYbeCA1 trial
evaluating eryaspase in second-line pancreatic cancer.
TRYbeCA1 is expected to enroll
approximately 500 patients with second-line metastatic pancreatic
cancer at more than 120 clinical sites in Europe and the United
States. In this trial, eligible patients are randomized 1-to-1 to
receive eryaspase in combination with standard chemotherapy
(gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or
chemotherapy alone. The primary endpoint of TRYbeCA1 is
overall survival. An interim efficacy analysis is planned for when
approximately two-thirds of events have occurred. The trial started
enrolling patients in Spain in September 2019 and is now actively
enrolling patients in several European countries. The notification
for the study to proceed in the US comes in addition to
clinical trial authorizations received in eleven European
countries.
"There is a high
unmet need for therapeutic options in pancreatic cancer,
particularly in metastatic patients who have progressed on
first-line chemotherapy. With the FDA's acceptance of the eryaspase
IND, we are excited to initiate US trial sites and to begin
enrolling patients in TRYbeCA1," stated Iman El Hariry, Chief
Medical Officer of ERYTECH. "We have
been pleased with the level of interest and enrollment from
European TRYbeCA1 sites thus far and will look to build upon the
momentum we have in Europe with investigators in the US. We
anticipate that the first US patient enrolled in TRYbeCA1 will be
in the third quarter of 2019. "
"We are very
pleased to learn that the FDA has reviewed our IND and is allowing
ERYTECH to proceed with the initiation of the TRYbeCA1 study in the
United States. This is good news for patients with pancreatic
cancer in the USA that now have another clinical trial opportunity
to combat this deadly disease" commented Dr. Manuel
Hidalgo, Chief, Division of Hematology and Medical Oncology at
Weill Cornell Medicine and New York Presbyterian Hospital.
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 approximately 150,000 new cases of
pancreatic cancer diagnosed in Europe and the United States.
Advanced pancreatic cancer is a particularly aggressive cancer,
with a five-year survival rate of less than 10%. It is currently
the fourth leading cause of cancer death in Europe and the United
States and is projected to rise to the second leading cause by
2030. Limited therapeutic options are currently available for this
indication, thereby reinforcing the need to develop new therapeutic
strategies and rational drug combinations with the aim of improving
overall patient outcomes and quality of life.
About
ERYTECH: www.erytech.com
ERYTECH is a clinical-stage
biopharmaceutical company developing innovative red blood
cell-based therapeutics for severe forms of cancer and orphan
diseases. Leveraging its proprietary ERYCAPS platform, which uses a
novel technology to encapsulate drug substances inside red blood
cells, ERYTECH is developing a pipeline of product candidates for
patients with high unmet medical needs.
ERYTECH's primary focus is on the
development of product candidates that target the altered
metabolism of cancer cells by depriving them of amino acids
necessary for their growth and survival. The Company's lead product
candidate, eryaspase, which consists of L-asparaginase encapsulated
inside donor-derived red blood cells, targets the cancer cell's
altered asparagine and glutamine metabolism. Eryaspase is in Phase
3 clinical development for the treatment of second-line pancreatic
cancer and in Phase 2 for the treatment of triple-negative breast
cancer. ERYTECH is also developing erymethionase, which consists of
methionine-gamma-lyase encapsulated in red blood cells to target
methionine-dependent cancers.
ERYTECH produces product
candidates at its GMP-approved manufacturing site in Lyon,
France, and at the American Red Cross in Philadelphia, USA. A
large-scale GMP manufacturing facility has recently completed
construction in Princeton, New Jersey, USA.
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.
ERYTECH
Eric Soyer
CFO & COO |
NewCap
Mathilde Bohin / Louis-Victor
Delouvrier
Investor relations
Nicolas Merigeau
Media relations |
+33 4 78
74 44 38
investors@erytech.com |
+33 1 44
71 98 52
erytech@newcap.eu |
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, expansion of manufacturing
capacity 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. All statements contained in
this press release other than statements of historical facts are
forward-looking statements, including, without limitation,
statements regarding the potential of ERYTECH's product pipeline,
its clinical development of eryaspase, and the timing of ERYTECH's
preclinical studies and clinical trials and announcements of data
from those studies and trials. 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
(AMF), the Company's Securities and Exchange Commission (SEC)
filings and reports, including in the Company's 2018 Document de
Référence filed with the AMF on March 29, 2019 and in the Company's
Annual Report on Form 20-F filed with the SEC on March 29, 2019 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.