Celyad completes the
NKR-2 Phase I trial with successful safety follow-up of the fourth
dose level
- No safety issues or dose limiting toxicity reported.
- The trial was a single administration, dose escalation study
evaluating the safety and feasibility of NKR-2 T-cell therapy in
patients with Acute Myeloid Leukemia or Multiple Myeloma.
- Results of the trial are expected to be available in late Q4
2016
Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of cell therapies, today announced
the successful completion of the 21-day safety follow-up of the
last patient enrolled at the fourth dose level in its Phase I
clinical trial evaluating the safety and feasibility of its NKR-2
T-cell therapy - in Acute Myeloid Leukemia and Multiple Myeloma
patients. No safety issues or toxicities were reported.
Dr. Christian Homsy, CEO of Celyad: "We
are pleased that no adverse safety signal has been reported. Based
on the successful completion of the fourth cohort, we are looking
forward to starting the global Ph I/IIa multiple dose trial, in the
US and EU, of our NKR-2 autologous therapy in the fourth quarter of
this year."
Dr. Frédéric Lehmann, Head of Immuno-Oncology
at Celyad: "The absence of any safety or toxicity signal up to
this point continues to support our belief that this unique
engineered T-cell construct can be safely administered and
potentially lead to a therapeutic effect providing hope to the
thousands of patients who need better treatments for both AML and
MM."
***END***
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 mechanism of actions and goes beyond direct killing by
signifying that its encoded T-Cells attack the tumor cells, inhibit
the mechanisms that enable tumors to evade the immune system,
activate and recruit anti-tumor immune cells and disrupt 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.
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.
NKR-2 is currently being tested in a Phase I/IIa
trial in acute myeloid leukemia and multiple myeloma patients. The
trial is designed to assess the safety and feasibility of NKR-2,
with secondary endpoints including clinical activity. Key research
investigations include understanding the persistence of NKR-2 cells
within the patient.
For more information, please contact:
For Europe: Consilium Strategic Communications Chris
Gardner,Chris Welsh, and Laura Thornton -
T: +44 (0)20 3709 5700
-celyad@consilium-comms.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 |
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visitwww.celyad.com Follow us on Twitter @CelyadSA
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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, is currently
being evaluated in a Phase I/IIa clinical trial. 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
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.
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, 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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