Celyad announces initiation of the SHRINK trial
20 July 2017 - 3:00PM
Celyad SA/NV (EURONEXT Brussels:CYAD) (EURONEXT Paris:CYAD)
(NASDAQ:CYAD), a leader in the discovery and development of CAR-T
cell therapies, today announced the initiation of the SHRINK trial,
a third clinical trial with its lead product candidate CYAD-01
(CAR-T NKG2D), targeting metastatic colorectal patients.
SHRINK (Standard
CHemotherapy Regimen and
Immunotherapy with NKR-2) is an
open-label Phase I study evaluating the safety and clinical
activity of multiple doses of CYAD-01, administered concurrently
with the neoadjuvant FOLFOX treatment in patients with potentially
resectable liver metastases from colorectal cancer.
Dr. Christian Homsy, CEO of Celyad
commented: “We are happy to start the SHRINK trial as it
will allow us to evaluate the efficiency of our promising CYAD-01
therapy in combination with chemotherapy. We are confident that our
partnership with key Belgian cancer institutions will provide us
with new insights in the treatment of metastatic colorectal cancer.
Today’s announcement, in conjunction with our ongoing THINK trial
and the upcoming LINK study, reaffirms our commitment and
dedication to beat cancer with a strong focus on solid tumors.”
Dr. Frédéric Lehmann, VP Clinical
Development and Medical Affairs at Celyad added: “As
leaders in our field, it is our task to further develop the
potential of our CAR-T treatments. Starting SHRINK is another
important milestone for us and for patients worldwide, evaluating
the synergetic effect of the concurrent administration of our lead
candidate CYAD-01 with standard chemotherapy as first-line
treatment for metastatic colorectal cancers. We now look forward to
the first infusion of a colorectal patient in the coming weeks and
to the registration of other patients. The SHRINK study is one of
the new Celyad studies to be initiated in 2017 as part of a global
comprehensive clinical program supporting the development of our
CYAD-01 candidate.”
SHRINK will be conducted in Belgium in key
oncology centers. It contains a dose escalation and an extension
stage. The dose escalation design will include three dose levels
adjusted to body weight: up to 3x108, 1x109 and 3x109 of CYAD-01.
At each dose, the patients will receive three successive
administrations, two weeks apart at the specified dose. The dose
escalation part of the study will enroll up to 18 patients while
the extension phase would enroll 21 additional patients.
The colorectal cancer indication evaluated in
the SHRINK trial was selected based on evidence generated in the
pre-clinical settings and in the ongoing THINK study.
SHRINK is Celyad’s third clinical trial of its
CYAD-01 product candidate, a CAR-T cell therapy using NKG2D ligands
as a target. The two other trials are CM-CS1 (completed) and THINK
(ongoing).
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 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. 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. Preclinical 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 preclinical 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 preclinical research underlying this technology
was originally conducted at Dartmouth College by Dr. Charles
Sentman and has been published extensively in peer-reviewed
publications.
To subscribe to Celyad’s newsletter,
visit www.celyad.comFollow us on LinkedIn &
Twitter @CelyadSA
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 CYAD-01 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 I clinical trial for
CYAD-01; 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.
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: NewCap
Pierre Laurent and Nicolas Mérigeau - T: + 33(0)1 44 71 94 94 - celyad@newcap.eu
For Belgium: Comfi
Gunther De Backer and Sabine Leclercq - T.: +32 (0)2 290 90 90 - celyad@comfi.be
For the U.S.: Stern Investor Relations
Will O’Connor and Michael Schaffzin - T.: +1 212.362.1200 - celyad@sternir.com
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From Apr 2024 to May 2024
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From May 2023 to May 2024