Celyad Completes 30-Day Safety Follow-Up of First Patient of Second Cohort in NKG2D CAR T-Cell Phase I Trial
January 05 2016 - 1:00AM
Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (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 completion of the 30-day
safety follow-up of the first patient enrolled in the second
cohort in the Phase I clinical trial evaluating the safety and
feasibility of its NKG2D CAR T-cell therapy, in cancer patients
suffering from acute myeloid leukemia (AML) or multiple myeloma
(MM).
Dr. Christian Homsy, CEO of Celyad,
said: “The NKG2D CAR T-Cell Phase I trial is progressing
well. No safety issue were reported since the beginning of the
trial. We look forward to recruiting the next patients in this
second dose cohort”.
Dr. Frédéric Lehmann, Head of
Immuno-oncology at Celyad, added: “Our NKG2D CAR T-Cell
Phase I study is advancing at a nice pace and according the initial
plans. No safety issue were reported after the first dose cohort
and the second one knows a good start. I am grateful to our Phase 1
investigators who have positioned us so well for this
milestone”.
The Phase I/IIa trial is designed to assess the
safety and feasibility of NKG2D CAR T-Cells, with secondary
endpoints including clinical activity in two different
haematological indications. 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 enroll 12 additional patients.
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 :
NewCapPierre Laurent and
Nicolas Mérigeau - T: + 33(0)1 44 71 94
94 - celyad@newcap.eu |
For Belgium : ComfiGunther De Backer:
t.: +32 (0)2 290 90 90 – gunther@comfi.be |
CelyadChristian Homsy, CEO and
Patrick Jeanmart, CFO : T :
+32 (0)10 39 41 00
investors@celyad.com |
|
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visit www.celyad.comFollow 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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