Celyad (Euronext Brussels:CYAD) (Euronext Paris:CYAD)
(NASDAQ:CYAD), a leader in the discovery and development of
engineered cell-based therapies, today announced a further step in
the CAR-T NKR-2 THINK trial with the registration of a first
refractory Multiple Myeloma patient. This patient is expected to
receive the first dose-level (3x108 CAR-T NKR-2 cells) in the
coming weeks, opening the first cohort of the hematological arm of
the study.
“Following the registration of three patients in
solid indications, the THINK trial is now following on from our
previous NKR-2 Phase I trial which demonstrated the safety and
signs of efficacy of CAR-T NKR-2 cells in cancer patients suffering
from hematological cancers,” said Christian Homsy, CEO of
Celyad. “We now look forward to enrolling patients
suffering from AML or MM into the hematological arm of THINK and we
hope that the related results will be as encouraging as they have
been so far with lower dose levels.”
“Multiple Myeloma causes approximately 10% of
all hematologic malignancies, and while efficient treatments are
available, most patients will eventually relapse. Celyad has
generated breakthrough preclinical data in murine models, leading
to 100% long-term survival. The enrollment of a first refractory
Multiple Myeloma patient demonstrates the consistency of our
clinical approach and highlights the unique ability of our CAR-T
NKR-2 technology to target both solid and hematological
malignancies,” remarked Dr. Frédéric Lehmann, VP Clinical
Development and Medical Affairs at Celyad.
About the THINK trialTHINK
(THerapeutic Immunotherapy with
NKR-2) is a multinational (EU/US) open-label Phase
Ib study to assess the safety and clinical activity of multiple
administrations of autologous CAR-T NKR-2 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).
The trial will test three dose levels adjusted
to body weight: up to 3x108, 1x109 and 3x109 CAR-T NKR-2 cells. At
each dose, the patients will receive three successive
administrations, two weeks apart, of CAR-T NKR-2 cells. The dose
escalation part of the study will enroll up to 24 patients while
the extension phase would enroll 86 additional patients.
About CelyadCelyad 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, the CAR-T NKR-2, has been evaluated in a single dose
escalation Phase I clinical trial to assess the safety and
feasibility of CAR-T NKR-2 cells in patients suffering from AML or
MM. This Phase I study was successfully completed in September
2016. 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
platform, using Natural Killer Receptor (NKR) transduced on to T
lymphocytes. The platform targets 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, CAR-T NKR-2, is a
CAR-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 CAR- T 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 recruits 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 CAR-T NKR-2 administrations. For autologous CAR‑T 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 |
For the U.S.: Stern Investor RelationsWill
O’Connor and Michael Schaffzin – T.:
+1 212.362.1200 – celyad@sternir.com |
To subscribe to Celyad’s newsletter,
visit www.celyad.com
Follow us on LinkedIn &
Twitter @CelyadSA
Forward looking statementsIn
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 CAR-T
NKR-2 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 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 CAR-T 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.
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From Jul 2023 to Jul 2024