Celyad Announces Positive New Data from its CAR-T
NKR-2 Phase I Trial at 2016 ASH Annual Meeting
Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of engineered cell-based therapies,
presented new data from the Phase I trial of NKR-2 in patients with
acute myeloid leukemia (AML) and multiple myeloma (MM) at the 2016
American Society of Hematology (ASH) Annual Meeting being held in
San Diego, CA from December 3-6, 2016. NKR-2 is a CAR-T product
candidate using NKG2D, an NK Cell activating receptor transduced on
T lymphocytes.
"We are pleased with the early evidence of
activity in AML and MM patients in our low single dose regime
testing. This efficacy and clean safety profile support our belief
that NKR-2 is differentiated from other CAR-T therapies in
development," said Dr. Christian Homsy, CEO of Celyad. "We look
forward to initiating our THINK (Therapeutic Immunotherapy with
NKR-2) study designed to evaluate NKR-2 at higher doses and with
multiple administrations in both solid and liquid tumors in the
near term."
Data presented demonstrate the drug to be safe
and well tolerated in the highest dose level tested to date (3x107)
as well as showing early efficacy signals, including prolonged
survival in both AML and MM patients. Highlights of the data
include:
- Strong safety signals, including no cases of cytokine release
syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T
related death.
- Although no blast reduction was observed, an AML patient
reported no progression (3+months) and improvement in all
hematological parameters under no additional therapy at the highest
dose (3x107).
- Other previously reported patients also showed prolonged
survival with unanticipated responses to subsequent treatments, and
improvements in hematological parameters despite aggressiveness of
baseline disease.
- In vitro testing of the two patients for which tumor samples
were available showed that CAR-T NKR-2 destroyed tumor cells,
confirming the relevance of the previously published pre-clinical
work.
Dr. Frédéric Lehmann, VP Clinical
Development & Medical Affairs at Celyad: "We are very
encouraged by these interim clinical and correlative data of this
Phase I safety trial evaluating CAR-T NKR-2 in refractory AML and
multiple myeloma patients who have limited or no treatment options.
Celyad is eagerly awaiting the initiation of the THINK study
designated to evaluate CAR-T NKR-2 at higher doses and with a
multiple administrations schedule in these hematological
indications and in five solid tumor types."
CAR-T NKR-2 Phase I trial data results were
presented at the poster session of the ASH Annual Meeting, on
Monday, December 5th 2016.Title: Safety Data from
a First-in-Human Phase 1 Trial of NKG2D Chimeric Antigen Receptor-T
Cells in AML/MDS and Multiple Myeloma (Poster
Presentation)Abstract: 4052Session:
616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Poster IIILocation: San Diego
Convention Center, Hall GH
About the CAR-T NKR-2 Phase 1
Trial
The CAR-T NKR-2 Phase I trial is a single
infusion, dose escalation study evaluating the safety and
feasibility of NKR-2 CAR-T cells in AML and MM patients. 12
patients were treated at low escalating doses NKR-2 cells (max
3x107). This study was completed in September 2016 with a
successful safety follow-up for all dose level cohorts.
Conference Call Details (Conference ID:
30079023)
A conference call will be held on Wednesday,
December 7, 2016 at 2:00pm (CET) / 8:00am (EDT) to review the
topline results of the CAR-T NKR-2 Phase I safety trial and to
present NKR-T clinical development plan with the initiation of the
THINK trial. Christian Homsy, Chief Executive Officer, and David
Gilham, Vice-President Research and Development, will deliver a
brief presentation followed by a Q+A session.
Audio Conference Joining
Instructions: in the ten minutes prior to call start time,
call the appropriate Participant Dial-In Number listed below. Enter
the following Direct Event Passcode 3345179 and
you will be joined automatically to the conference.
The call can be accessed by dialing the numbers
below:
- Standard International Dial-in
Number:
+44 (0) 1452 553430
- Belgium Free Call Dial-In
Number:
080048711
- France Free Call Dial-In
Number:
0805631562
- UK Free Call Dial-In
Number:
08006945720
- US Free Call Dial-In
Number:
18663311865
The conference slideshow will be available
during the call at
https://webconnect.webex.com/webconnect/onstage/g.php?MTID=e678a000da16ca49230d4c2560a8fec23
***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, the CAR-T 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. 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, 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 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 |
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 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 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 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.
C3BS-CQR-1, C-Cure®, NKG2D CAR T-cell,
CAR-T 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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