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 21-day
safety follow-up of the last patient enrolled in the second
dose level in the Phase I/IIa clinical trial evaluating the safety
and feasibility of its NKR-2 T-cell therapy using T-cells with
NKG2D receptor in cancer patients suffering from acute myeloid
leukemia (AML) or multiple myeloma (MM).
Dr. Christian Homsy, CEO of Celyad,
said: “The NKR-2 Phase I trial is progressing well. No
product related safety issue were reported since the beginning of
the trial. We look forward to treating the next patient who will be
the first of the third dose cohort”.
Dr. Frédéric Lehmann, Head of
Immuno-oncology at Celyad, added: “We are pleased of the
progression of this study which remains encouraging so far with no
safety issue reported and a good enrolment of patients along the
first two cohorts. We are grateful to our Phase 1 investigators at
the Dana Farber Cancer Institute for their work to achieve this
milestone”.
NKR stands for Natural Killer Receptor. NKG2D
CAR T-cells are now called NKR-2 T-cells and the product
development name is NKR-2.
Existing CAR-T cells are engineered using
constructs encoding an antibody single chain variable fragment, the
signalling domain of CD3 zeta and one or more co-stimulatory
domain(s). While very favourable outcomes have been presented
using CD19 based constructs, current CAR-T target a limited set of
cancers. NKR-2 was generated by fusion of the native human
NKG2D receptor gene with the human CD3 zeta cytoplasmic signalling
domain and uses the natural co-stimulatory molecule DAP10. This new
generation construct allows the targeting of a much broader set of
cancers via the recognition of eight well characterized NKG2D
ligands, MICA, MICB and ULBP 1-6. Those ligands are expressed on
most blood and solid tumors.
The Phase I trial is designed to assess the
safety and feasibility of NKR-2, in two different haematological
indications. The safety follow-up period post-infusion has
been decreased to 21 days after approval by the U.S. Food and Drug
Administration (FDA) and Institutional Review Board (IRB).
Data readouts from the first 12 patients treated in the Phase I
portion are expected in mid-2016, once a recommended dose is
determined.
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 NKR-2
Celyad’s lead immuno-oncology product candidate,
NKR-2, is a T-Cell encoded to express the Natural Killer activating
receptor, NKG2D. The technology developed by Celyad uses a human
natural killer cell (NK cell) receptor which, unlike traditional
CAR technologies, targeting the CD19 antigen, has the potential to
target ligands expressed 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. NKR-2 has an active Investigational New
Drug (IND) application with the FDA for a Phase I clinical trial in
certain hematologic cancers.
NKR-2 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 NKR-2 in acute myeloid
leukemia and multiple myeloma patients, 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 next generation 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, NKR-2 (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 NKR-2-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 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 NKR-2. These data may not continue for
these subjects or be repeated or observed in ongoing or future
studies involving our NKR-2 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 NKR-2; 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, NKR-2,
C-CathezTM, OnCyte, Celyad, 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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