- No safety issues or dose limiting toxicity reported in the
first patient at the fourth dose level.
- Next patient, 11th of the trial, has been infused.
- The trial is a dose escalation study evaluating safety and
feasibility of NKR-2 T-cell therapy in patients with Acute Myeloid
Leukemia or Multiple Myeloma.
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
first patient enrolled at the fourth dose level in its Phase I/IIa
clinical trial evaluating the safety and feasibility of its NKR-2
T-cell therapy using T-cells engineered to express the NKG2D
receptor 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. The next patient of the
cohort has already been infused. We continue to accumulate evidence
in this human trial consistent with our pre-clinical data that no
preconditioning or lymphodepletion is required to administer these
unique natural killer receptor expressing T-cells
successfully".
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 |
To subscribe to Celyad's newsletter,
visitwww.celyad.com Follow us on Twitter @CelyadSA
and on LinkedIn
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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