Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of engineered cell therapies, today
announces the approval in Belgium to initiate the THINK clinical
trial. THINK is the second clinical trial of its NKR-2 product
candidate, a CAR-T cell therapy using NKG2D ligands as a target, to
evaluate safety and efficacy in seven cancer indications including
both solid and hematological malignancies.
THINK (THerapeutic
Immunotherapy with NKR-2) is a
multinational open-label Phase Ib study to assess the safety and
clinical activity of multiple administrations of autologous NKR-2
T-cells in seven, refractory cancers including five solid tumors
(colorectal, ovarian, bladder, triple-negative breast and
pancreatic cancers) and two hematological tumors (acute myeloid
leukemia and multiple myeloma).
This trial will be conducted in the US and in
Europe. It contains a dose escalation and an extension stage. The
dose escalation will be conducted in parallel in the solid tumor
and in the liquid cancer groups, while the extension phase will
evaluate in parallel each tumor independently.
The dose escalation design will include three
dose levels adjusted to body weight: up to 3x108, 1x109 and 3x109
NKR-2 T-cells. At each dose, the patients will receive three
successive administrations, two weeks apart, of NKR-2 T-cells at
the specified dose. The dose escalation part of the study will
enroll up to 24 patients while the extension phase would enroll 86
additional patients.
The seven indications evaluated in the THINK
trial were selected based on evidence generated in the pre-clinical
settings and in the first study recently completed (a Phase I
single injection, dose escalation study evaluating NKR-2 T-cells in
12 patients suffering from Acute Myeloid Leukemia (AML) or Multiple
Myeloma (MM) at Dana Farber Cancer Institute in Boston, MA,
USA).
Dr. Christian Homsy, CEO of Celyad
commented: "We are extremely happy to be able to start
this next phase of the clinical development program of NKR-2,
building on the successful outcome of the single dose, dose
escalation trial, to be presented at ASH. We now look forward
to treating the first patients in Belgium, and to receiving FDA
clearance to initiate the trial at our US-based sites."
Dr. Frédéric Lehmann, VP Clinical
Development and Medical Affairs at Celyad added: "We are
excited to initiate this multiple tumor study with key cancer
institutions in Belgium. While immunotherapy is rapidly
transforming the treatment of patients with cancer, there remains a
significant unmet medical need for more effective therapies. It is
our hope that Celyad's NKR-2 T-cells have the potential to be truly
disruptive in the way we treat cancer and this study is one more
step towards that goal."
***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 CAR-T cell using
Natural Killer Receptors (NKR) receptors, transduced on T
lymphocytes, 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.
For more information, please
contact:
For Europe: Consilium Strategic Communications
Chris Gardner and Chris Welsh
- 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 and
Sabine Leclercq: T.: +32 (0)2 290 90 90 -
celyad@comfi.be |
CelyadChristian Homsy, CEO and
Patrick Jeanmart, CFO: T:
+32 (0)10 39 41 00
investors@celyad.com |
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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, 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 on-going ex parte re-examination of
the Company's U.S. patent number 9,181,527, including the risk that
the U.S. Patent and Trademark Office may decide to cancel all or a
portion of the claims contained therein, 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 Annual Report on Form 20-F filed with the SEC on
April 8, 2016 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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