Celyad publishes additional pre-clinical data in support of THINK trial
June 21 2017 - 5:00AM
Celyad SA (EURONEXT Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD),
a leader in the discovery and development of CAR-T cell therapies,
today announces it has published a special report in the
peer-reviewed journal “Future Oncology” summarizing pre-clinical
work undertaken on NKR-2, the CAR-T cell therapy currently tested
in the company’s THINK trial.
Celyad’s special report entitled Exploiting
Natural Killer Group 2D Receptors for CAR-T cell therapy discloses
new results confirming the potency of CAR-T NKR-2 cells against
various human cancer cell lines in vitro including leukemia,
colorectal and pancreatic cancer. Furthermore, new data show
the ability of CAR-T NKR-2 cells to effectively challenge
established pancreatic cancer xenografts in humanized mouse
models.
These pre-clinical studies were performed with
Celyad’s long-term collaborator Professor Charles Sentman and
further confirm the choice of indications being investigated in the
ongoing THINK trial.
Dr. David Gilham, VP of Research &
Development at Celyad: “This publication provides
important additional pre-clinical evidence supporting the range of
cancer indications being explored in the THINK trial. This is an
example of our on-going work to further define and understand the
mechanisms of action of CAR-T NKR-2 cells that will provide greater
insight to support our developing clinical program.”
Dr. Christian Homsy, CEO of
Celyad: “We are pleased to provide further pre-clinical
evidence validating our approach in the THINK trial, in which we
aim to demonstrate the potential of CAR-T NKR-2 cells as a
disruptive technology in the treatment of cancer.”
Celyad’s special report is available on Future Oncology’s
website:
http://www.futuremedicine.com/doi/abs/10.2217/fon-2017-0102
About Celyad
Celyad is a clinical-stage biopharmaceutical
company focused on the development of specialized CAR-T cell based
therapies. The company utilizes its expertise in cell engineering
to target cancer. Celyad’s Natural Killer Receptor based T-Cell
(NKR-T) platform has the potential to treat a broad range of solid
and hematologic tumors. Its lead oncology candidate, the CAR-T
NKR-2, has been evaluated in a single dose escalation Phase
1 clinical trial to assess the safety and feasibility of CAR-T
NKR-2 cells in patients suffering from AML or MM. This Phase
1 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 the THINK trial
THINK (THerapeutic Immunotherapy with NKR-2) is a
multinational (EU/US) open-label Phase 1b 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 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.
CAR-T NKR-2 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. Pre-clinical results
indicate that CAR-T NKR-2 has multiple mechanisms of actions and
goes beyond direct cancer cell killing. It 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 development of a long-term immune memory
against specific tumor antigens of the targeted tumor.In contrast
to traditional CAR-T therapeutic approaches, and based on strong
pre-clinical evidence, Celyad’s current CAR-T NKR-2 program does
not use 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 approaches. 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, to
also express TCR Inhibitory Molecules (TIMs), to avoid having the
donor cells rejected by the patient’s normal tissues (also called
Graft vs. Host Disease).The pre-clinical 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 |
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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 CAR-T NKR-2 cell therapy, 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 1 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.
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