USPTO rejects new reexamination request against Celyad’s US Patent for Production of Allogeneic TCR-Deficient CAR-T Cells
March 16 2017 - 2:00AM
Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a
leader in the discovery and development of engineered cell-based
therapies, today announced that the U.S. Patent and Trademark
Office (USPTO) has decided to reject a new reexamination request of
Celyad’s U.S. Patent No. 9,181,527, relating to allogeneic human
primary T-cells that are engineered to be TCR-deficient and express
a CAR. The patent remains valid and enforceable.
“This is the fourth time that our US Patent for
Production of Allogeneic TCR-Deficient CAR-T cells is challenged
and each time, the USPTO has been favorable to Celyad. This patent
is key for the players that are developing in the US allogeneic
CAR-T cell approaches and it places Celyad in a very good position
to optimize the significant potential of its allogeneic platform,
either on our own or through strategic collaborations”,
said Christian Homsy, CEO of Celyad.
About the THINK
trial
THINK (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
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 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.
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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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 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 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.
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