Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of engineered cell therapies, with
clinical programs in cardiovascular disease and immuno-oncology,
today announced the infusion of the first patient of the second
cohort of its Phase I clinical trial evaluating the Company's NKG2D
CAR T-Cell therapy in acute myeloid leukaemia (AML) and multiple
myeloma (MM) indications.
Dr. Christian Homsy, CEO of Celyad, said: "The
treatment of the first patient enrolled in the second cohort of our
first-in-man Phase I trial evaluating NKG2D CAR T-Cells
demonstrates continued progress in developing our lead
immune-oncology program. Once the safety evaluation is complete, we
expect to continue enrolment in the study to further evaluate the
therapy's safety and to determine an appropriate dose. Due to its
unique ability to target ligands present on most cancers, we
believe our NKG2D CAR T-Cells have potential as a new treatment
option for patients with a broad range of cancer types, including
haematological malignancies and various solid tumours."
Dr. Frédéric Lehmann, Vice President of Immuno-Oncology
at Celyad, added: "We are proud to have advanced our first
NKG2D CAR T-Cell Phase I study so rapidly. I am grateful to our
dedicated investigators at Dana Farber Cancer Institute and look
forward to completing enrolment in this important trial. Celyad
continues to be committed to developing immune-oncology CAR-T
programs that should provide clinically meaningful benefit for
patients."
The Phase I/IIa trial is designed to assess the safety and
feasibility of NKG2D CAR T-Cells, with secondary endpoints
including clinical activity. Data readouts from the first 12
patients treated in the Phase I portion are expected in mid-2016.
Once the recommended dose is determined, the IIa phase of the trial
will commence, with 12 additional patients treated at the
recommended dose.
For more information, please contact:
For Europe : Consilium
Strategic Communications Amber Fennell,
Chris Gardner, Chris Welsh, and
Laura Thornton -- T:
+44 (0)20 3709 5700 –
celyad@consilium-comms.com |
For the U.S. : The Ruth
Group Lee Roth (Investors), and
Kirsten Thomas (Media) - T:
+1 646 536 7012 / 7014
-- celyad@theruthgroup.com |
For France :
NewCap Pierre Laurent and Nicolas
Mérigeau -- T: + 33(0)1 44 71 94 94 --
celyad@newcap.eu |
For Belgium :
Comfi Gunther De Backer: t.: +32 (0)2 290 90 90
– gunther@comfi.be |
Celyad Christian
Homsy, CEO and Patrick Jeanmart,
CFO : T :
+32 (0)10 39 41 00 investors@celyad.com |
To subscribe to Celyad's
newsletter, visit www.celyad.com
Follow us on Twitter @CelyadSA
About CAR-NKG2D
Celyad's lead immuno-oncology product candidate, CAR-NKG2D, is a
chimeric antigen receptor (CAR) T-Cell autologous therapy to treat
cancer. The CAR technology developed by Celyad uses human natural
killer cell (NK cell) receptor which, unlike traditional CAR
technologies such as those targeting the CD19 antigen, has the
potential to target ligands present on a broad range of solid
tumors and blood cancers.
The research underlying this technology was originally conducted
by Dartmouth College Professor Charles Sentman, and has been
published in numerous peer-reviewed publications such as Journal of
Immunology in 2009, Cancer Research in 2006, and Blood in 2005.
CAR-NKG2D has an active Investigational New Drug (IND) application
with the FDA for a Phase I clinical trial in certain hematologic
cancers.
CAR-NKG2D entered a Phase I clinical trial in April
2015. The full data readout from the Phase I dose escalation
trial is expected in mid-2016. The trial is designed to assess
the safety and feasibility of NKG2D CAR T-cell in certain acute
myeloid leukemia and multiple myeloma patients as primary
endpoints, with secondary endpoints including clinical
efficacy.
About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in
engineered cell therapy with clinical programs initially targeting
indications in cardiology and oncology. Celyad is developing its
lead cardiovascular disease product candidate, C-Cure®, for the
treatment of ischemic heart failure, and has completed enrollment
of a Phase III trial in Europe and Israel. In addition, the Company
is developing a novel portfolio of CAR T-cell therapies that
utilize human Natural Killer cell receptors for the treatment of
numerous blood and solid cancers. Its lead oncology product
candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in
April 2015.
Celyad's ordinary shares are listed on Euronext Brussels and
Euronext Paris under the ticker symbol CYAD and Celyad's American
Depositary Shares are listed on the NASDAQ Global Market under the
ticker symbol CYAD.
To learn more about Celyad, please visit
www.celyad.com
Forward looking statements
In addition to historical facts or statements of current
condition, this press release contains forward-looking statements,
including statements about the potential safety and feasibility of
NKG2D CAR T-cell therapy and C-Cure and the clinical potential of
the Company's technology platform generally and the timing of
future clinical trials, which reflect our current expectations and
projections about future events, and involve certain known and
unknown risks, uncertainties and assumptions that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements.
In particular it should be noted that the 30-day safety data
described in the release are preliminary in nature and the Phase 1
trial is not completed. There is limited data concerning safety and
feasibility of NKG2D CAR T-cell therapy. These data may not
continue for these subjects or be repeated or observed in ongoing
or future studies involving our NKG2D CAR T-cell therapy, C-Cure or
other product candidates. It is possible that safety issues or
adverse events may arise in the future.
These forward-looking statements are further qualified by
important factors, which could cause actual results to differ
materially from those in the forward-looking statements, including
risks associated with conducting clinical trials; the risk that
safety, bioactivity, feasibility and/or efficacy demonstrated
in earlier clinical or pre-clinical studies may not be replicated
in subsequent studies; risk associated with the timely submission
and approval of anticipated regulatory filings; the successful
initiation and completion of clinical trials, including Phase III
clinical trials for C-Cure® and Phase I clinical trial for NKG2D
CAR T-cell; risks associated with the satisfaction of regulatory
and other requirements; risks associated with the actions of
regulatory bodies and other governmental authorities; risks
associated with obtaining, maintaining and protecting intellectual
property, our ability to enforce our patents against infringers and
defend our patent portfolio against challenges from third parties;
risks associated with competition from others developing products
for similar uses; risks associated with our ability to manage
operating expenses;, and risks associated with our ability to
obtain additional funding to support our business activities and
establish and maintain strategic business alliances and business
initiatives. A further list and description of these risks,
uncertainties and other risks can be found in the Company's
Securities and Exchange Commission filings and reports, including
in the Company's prospectus filed with the SEC on June 19, 2015 and
future filings and reports by the Company. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. The Company expressly disclaims any obligation to update
any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based, unless required by law or regulation.
C3BS-CQR-1, C-Cure, NKG2D CAR T-cell, C-Cathez TM, OnCyte,
Celyad, Cardio3 BioSciences and the Cardio3 BioSciences, Celyad,
C-CathezTM, CHART-1, CHART-2 and OnCyte logos are signs
internationally protected under applicable Intellectual Property
Laws. Mayo Clinic holds equity in Celyad as a result of
intellectual property licensed to the Company.
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