Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of engineered cell therapies, today
announces that first data analysis of the NKR-2 Phase I trial shows
encouraging results which will be presented during a poster session
at the 58th American Society of Hematology (ASH) Annual Meeting,
taking place on December 3-6, 2016, in San Diego, CA.
The NKR-2 Phase I trial is a single infusion,
dose escalation study evaluating the safety and feasibility of
NKR-2 T-cells in Acute Myeloid Leukemia and Multiple Myeloma
patients. This study was completed in September 2016 with a
successful safety follow-up for all dose level cohorts. There were
no cases of cytokine release syndrome, cell-related neurotoxicity,
auto-immunity, or CAR-T related death.
Based on recent analysis, encouraging clinical
update and correlative analysis, including post-infusion
immunophenotyping, will be presented at the poster session of the
ASH Annual Meeting:
Title: Safety Data from a First-in-Human
Phase 1 Trial of NKG2D Chimeric Antigen Receptor-T Cells in AML/MDS
and Multiple Myeloma (Poster Presentation)Abstract:
4052Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Poster IIIPresentation: Monday, December 5, 2016,
6:00pm - 8:00pm PSTLocation: San Diego Convention Center, Hall
GH
Dr. Christian Homsy, CEO of Celyad
commented: "NKR-2 Phase I trial was a safety study with
the primary objective of ensuring that there was no on-target,
off-tumor toxicity. We are positively surprised at reports of
unexpected clinical benefit, while testing just one single infusion
dosed between 50 and 1,000 times lower than our expected
efficacious dose extrapolated from animal experiments. Our
exceptionally strong animal data was obtained with three injections
of human equivalent doses of 1 to 2 billion cells per injection,
while the highest dose tested in the NKR-2 study was 30 million
cells in a single infusion. These results are therefore encouraging
and we look forward to triggering the next phase of our NKR-T
program once European agencies and the FDA have approved our THINK
trial protocol".
Dr. Frédéric Lehmann, VP Immuno-Oncology
at Celyad: "We are excited to present these data at ASH
and to explore the full potential of our NKR-2 autologous therapy
in our next development phase. The THINK trial will evaluate the
clinical activity and safety in seven indications, in both
hematologic malignancies and solid tumors. It is our hope that this
study will be the foundation of a robust approach to treating
patients with advanced tumors."
Dr. David Gilham, VP Research and
Development at Celyad: "NKR-2 CAR T cell therapy was
designed to act like a drug with short term persistence and
multiple injections in order to provide a better controlled and
more predictable safety profile than that of other traditional
CAR-T products. The primary objective is to avoid uncontrolled
in-vivo cell expansion and long term persistence thereby replacing
this paradigm with well controlled pharmacokinetics. We are
re-assured to note that the safety outcome of this Phase I study
confirms the pre-clinical animal data generated to date."
***END***
About Celyad
Celyad is a clinical-stage biopharmaceutical
company focused on the development of specialized cell-based
therapies. The Company utilizes its expertise in cell engineering
to target severe diseases with significant unmet need, including
cancer. Celyad's Natural Killer Receptor based T-Cell (NKR-T)
platform has the potential to treat a broad range of solid and
liquid tumors. Its lead oncology candidate, NKR-2, has been
evaluated in a single dose escalation Phase I clinical trial to
assess the safety and feasibility of NKR-2 T-cells in patients
suffering from AML or MM. In addition, Celyad has completed a Phase
III trial in the EU for its C-Cure® cardiovascular disease
candidate in ischemic heart failure. Celyad was founded in 2007 and
is based in Mont-Saint-Guibert, Belgium, and Boston, Massachusetts.
Celyad's ordinary shares are listed on the Euronext Brussels and
Euronext Paris exchanges, and its American Depository Shares are
listed on NASDAQ Global Market, all under the ticker symbol
CYAD.
For more information about Celyad, please visit:
www.celyad.com
About Celyad's NKR-T Cell
Platform
Celyad is developing a unique Natural Killer
Receptor (NKR) based T-Cell platform to target a wide range of
solid and hematological tumors. Unlike traditional CAR-T cell
therapy, which target only one tumor antigen, Natural Killer (NK)
cell receptors enable a single receptor to recognize multiple tumor
antigens.
Celyad's lead candidate, NKR-2, is a T-Cell
engineered to express the human NK receptor, NKG2D, which is an
activating receptor that triggers cell killing through the binding
of NKG2D to any of eight naturally occurring ligands that are known
to be overexpressed on more than 80% of tumors.
Preclinical results indicate that NKR-2 has
multiple mechanisms of actions and goes beyond direct killing by
signifying that its encoded T-Cells attack the tumor cells,
inhibits the mechanisms that enable tumors to evade the immune
system, activates and recruit anti-tumor immune cells and disrupts
the blood supply to the tumor. These mechanisms promote the
induction of adaptive immunity, meaning the body develops a
long-term cell immune memory against specific tumor antigens of the
targeted tumor.
In contrast to traditional CAR-T therapeutic
approaches, and based on strong preclinical evidence, Celyad's
current NKR-2 program does not employ patient lymphodepleting
pre-conditioning, thereby avoiding the toxicities associated with
chemotherapy and allowing the immune system to remain intact.
Celyad is developing both autologous and
allogeneic NKR-2 administrations. For autologous NKR-2, Celyad
collects the patient's own T-Cells and engineers them to express
NKG2D in order to target cancer cells effectively. Celyad's
allogeneic platform engineers the T-Cells of healthy donors, that
also express TCR Inhibitory Molecules (TIMs), to avoid having the
engineered donor cells be rejected by the patient's normal tissues
(also called Graft vs. Host Disease).
The preclinical research underlying this
technology was originally conducted at Dartmouth College by Dr.
Charles Sentman and has been published extensively in peer-reviewed
publications.
About the ASH Annual
meeting
Organized by the American Society of Hematology,
the ASH Annual Meeting is the world's premier event in malignant
and non-malignant hematology. The meeting gathers more than 20,000
international hematology professionals from every subspecialty and
provides an opportunity to review thousands of scientific abstracts
highlighting updates in the hottest topics in hematology.
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 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 |
CelyadEU: Christian Homsy, CEO
and Patrick Jeanmart, CFO: T:
+32 (0)10 39 41 00
investors@celyad.com US: Graham
Morrell, VP Investor Relations & Communication:
gmorrell@celyad.com |
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visit www.celyad.com Follow us on LinkedIn
& Twitter @CelyadSA
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 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.
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, Celyad, 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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