Celyad (Euronext Brussels:CYAD) (Euronext Paris:CYAD)
(NASDAQ:CYAD), a pioneer in the discovery and development of CAR-T
cell therapies, today announces exciting early clinical results of
the first dose-level in the hematological arm of its THINK trial
(
THerapeutic
Immunotherapy with
CAR-T
NKG2D).
Christian Homsy, CEO of Celyad
comments: “We are pleased to have demonstrated the first
objective clinical response of CYAD-01 (a.k.a. CAR-T
NKG2D) as this is the very first time a relapsed,
refractory AML patient has reached a MLFS with gene-engineered
T cells without pre-conditioning lymphodepletion nor additional
other concurrent treatment to CYAD-01 administration. This success
further reinforces our confidence in our approach and the validity
of NKG2D ligands as a target. We will now use the collected
data to move forward with the next stage of our product
development: reinforcing responses in as many clinical
settings as possible.”
At the first dose-level 3x108 CYAD-01 T cells
were administered without any prior conditioning chemotherapy to a
cohort of three patients with hematologic cancer (two with AML and
one with Multiple Myeloma, MM). One AML patient has achieved
a MLFS after administration with CYAD-01 at the H. Lee Moffitt
Cancer Center and Research Institute (Florida, USA).
Dr. David Sallman, Assistant Member in
the Malignant Hematology Department of Moffitt Cancer Center,
comments, “The results announced today regarding CYAD-01
provide the first clinical validity of CYAD-01 as a tumor-specific
antigen-receptor and AML as a disease sensitive to gene-engineered
cell therapies. As antigen targeting offers significant challenges
in AML, this outcome brings hope for the further use of
gene-engineered T cells for patients with AML that have run out of
therapeutic options. It’s all the more striking that this outcome
was observed without any prior lymphodepletion highlighting the
potential of using a physiologic antigen-receptor.”
AML is a blood cancer characterized by a rapid
increase of abnormal white blood cells in the bone marrow, which in
turn affects the production of normal blood cells. More than 20,000
people in the US and almost as many people in Europe are diagnosed
every year with this type of blood cancer. As AML’s incidence
increases with age and as population ages, it is expected that a
growing number of people might be affected by this type of
cancer.
Dr. Frédéric Lehmann, Vice President
Clinical Development and Medical Affairs at Celyad adds:
“With this first objective and ongoing response, obtained without
additional treatments such as lymphodepletion, CYAD-01 confirms the
potential to treat relapsed refractory AML, one of the deadliest
cancers with a median overall survival of less than 4 months. The
concept of CAR-T cells with the NKG2D receptor is now progressing
to further validation.”
The THINK trial, conducted in the US and in
Europe, includes two stages: a dose escalation and an extension
stage. The dose escalation is being conducted in parallel in solid
cancers (colorectal, pancreatic, ovarian, triple negative breast
and bladder) and in hematologic (AML and MM) cancer groups, while
the extension phase will evaluate in parallel each tumor type
independently. The dose escalation design includes three dose
levels adjusted to body weight: up to 3x108, 1x109 and 3x109
CYAD-01. At each dose, the patients receive three successive
administrations, two weeks apart, of CYAD-01 at the specified dose.
To date, 14 patients have been dosed in the THINK trial. One Grade
Three and one Grade Four event have been observed, both resolved
within 72 hours. No dose limiting toxicities (DLT) nor deaths
related to the investigational product have been reported.
Celyad’s management will host a
conference call at 2pm CEST/8am EDT on Friday, October 6,
2017
Conference Call Details
A conference call will be held on Friday,
October 6, 2017 at 2:00pm (CEST) / 8:00am (EDT) to provide an
update on Celyad’s clinical strategy. Christian Homsy, Chief
Executive Officer, and Patrick Jeanmart, Chief Financial Officer,
will deliver a brief presentation followed by a Q&A session.
Participants are asked to call the assigned
numbers approximately five minutes before the conference call
begins.
The call can be accessed by dialling the numbers
below and using the passcode: 95148855
International: |
+44
(0) 2071 928338 |
Belgium: |
02
793 3847 |
France: |
0170700781 |
UK: |
0800
2796619 |
US: |
1 877
8709135 |
About Celyad
Celyad is a clinical-stage biopharmaceutical
company focused on the development of specialized CAR-T cell based
therapies. Celyad 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, CYAD-01 (CAR-T
NKG2D), has been evaluated in a single dose escalation Phase I
clinical trial to assess the safety and clinical activity of
multiple administrations of autologous CYAD-01 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). 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
the NASDAQ Global Market, all under the ticker symbol CYAD.
For more information about Celyad, please visit:
www.celyad.com
For more information, please
contact:
CelyadChristian Homsy, CEO et Patrick
Jeanmart CFO - T: +32(0) 10 39 41
00 –
investors@celyad.comNicolas Van Hoecke,
Director, Investor Relations & Communications - T:
+32(0) 10 39 41 48 –
nvanhoecke@celyad.com |
For Europe: Consilium Strategic Communications
Chris Gardner et Chris
Welsh - T:
+44 (0)20 3709 5700 –
celyad@consilium-comms.com |
For France: NewCapPierre
Laurent et Nicolas Mérigeau
- T: + 33(0)1 44 71 94 94 -
celyad@newcap.eu |
For Belgium: ComfiGunther De
Backer et Sabine Leclercq - T.: +32 (0)2
290 90 90 – celyad@comfi.be |
For the U.S.: Stern Investor RelationsWill
O’Connor et Michael Schaffzin – T.: +1
212.362.1200 – celyad@sternir.com |
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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, including current and planned
preclinical and clinical trials for Celyad’s product candidates;
the clinical and commercial potential of these product candidates
and the adequacy of Celyad’s financial resources; Celyad’s
intellectual property portfolio, including plans related thereto;
Celyad’s expectations regarding its strategic collaborations and
license agreements with third parties, including Novartis, Celdara
Medical, and Dartmouth College, and the potential impact of such
collaborations on Celyad’s future financial condition; and Celyad’s
expected cash burn, which reflect Celyad’s 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 and risks,
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 trials
or preclinical studies may not be replicated in subsequent trials
or studies; risks associated with the timely submission and
approval of anticipated regulatory filings; the successful
initiation and completion of clinical trials, including its
clinical trials 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, Celyad’s ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; risks associated with competition
from others developing products for similar uses; risks associated
with Celyad’s ability to manage operating expenses; and risks
associated with Celyad’s ability to obtain additional funding to
support its 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 Celyad’s U.S. Securities and Exchange Commission
(SEC) filings and reports, including in its Annual Report on Form
20-F filed with the SEC on April 4, 2017 and subsequent filings and
reports by Celyad. 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. Celyad 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.
- 1 MLFS for Morphological Leukemia-Free Status
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