Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a
leader in the discovery and development of engineered cell
therapies, with clinical programs in cardiovascular disease and
immuno-oncology, today announced the issuance of United States
Patent No. 9,273,283 (“US Patent 9,273,283”) relating to a method
of producing allogeneic primary human T cells that are engineered
to be T-Cell Receptor (TCR)-deficient and express a Chimeric
Antigen Receptor (CAR).
The US Patent 9,273,283 is the second patent of
Celyad allogeneic intellectual property portfolio that is awarded
by the United States Patent and Trademark Office (USPTO). The first
US patent (9,181,527) - that was granted to Celyad in November 2015
- was related to TCR deficient CAR T cells, regardless of the
method used to generate them. This new patent strengthens Celyad’s
coverage for its proprietary CAR T cells by adding broadly
protecting methods for making these modified allogeneic T cells,
and providing them as medicines. The resulting products may benefit
patients with various human disease conditions and particularly
cancer. By this reinforcement of the Company’s patent portfolio in
the CAR-T field, Celyad confirms its leadership in engineered cell
therapy, and in the allogeneic CAR T space.
Allogeneic technology has the potential to
broaden the therapeutic applications of CAR T-Cell immunotherapies
as it does not depend on cells derived from the patient.
Dr. Christian Homsy, CEO of Celyad:
“We are pleased to have obtained this new patent. To our
knowledge, this is the first patent covering a method of producing
allogeneic TCR-deficient CAR T-cells and administering them to
patients. Thanks to the combination of this patent with the US
Patent 9,181,527 that we received a few months ago, we have a
strong patent portfolio covering key elements in the allogeneic
TCR-deficient CAR T-cells production value chain. We intend to
maximize the significant potential of our allogeneic CAR T-cells
platform internally and externally through strategic collaborations
and partnerships”.
Dr. Peter de Waele, VP R&D and
Intellectual Property at Celyad: “Obtaining this patent
once again illustrates not only the innovative approach of our
NKR-T cell platform, but also our proprietary independence. It
provides support for our continuous efforts developing promising
allogeneic effective therapies, improving process efficiency and
broadening availability significantly”.
Celyad currently has pre-clinical studies
underway to develop allogeneic cancer therapies by using a TCR
Inhibitory Molecule, or “TIMTM”, in combination with a next
generation CAR construct that incorporates a Natural Killer
Receptor, or “NKR”. This proprietary process results in a
TCR-deficient NKR T-Cell aimed at eliciting no or a greatly reduced
graft- versus-host-disease (GVHD) response.
For more information, please
contact:
For Europe :
Consilium Strategic Communications Amber
Fennell, Chris Gardner, Chris
Welsh, and Laura Thornton - T:
+44 (0)20 3709 5700 –
celyad@consilium-comms.com |
For the U.S. : The Ruth Group Lee
Roth (Investors), and Kirsten Thomas
(Media) - T: +1 646 536 7012 / 7014
- celyad@theruthgroup.com |
For France :
NewCapPierre Laurent and
Nicolas Mérigeau - T: + 33(0)1 44 71 94
94 - celyad@newcap.eu |
For Belgium : ComfiGunther De Backer:
t.: +32 (0)2 290 90 90 – gunther@comfi.be |
CelyadChristian Homsy, CEO and
Patrick Jeanmart, CFO : T :
+32 (0)10 39 41 00
investors@celyad.com |
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visit www.celyad.comFollow us on Twitter
@CelyadSA
About Celyad
Founded in 2007, and based in Belgium, Celyad is
a leader in engineered cell therapy with clinical programs
initially targeting indications in cardiology and oncology. Celyad
is developing its lead cardiovascular disease product candidate,
C-Cure®, for the treatment of ischemic heart failure, and has
completed enrollment of a Phase III trial in Europe and Israel. In
addition, the Company is developing a novel portfolio of CAR T-cell
therapies that utilize human Natural Killer cell receptors for the
treatment of numerous blood and solid cancers. Its lead oncology
product candidate, NKR-2 T-cell, entered a Phase I clinical trial
in April 2015.
Celyad’s ordinary shares are listed on Euronext
Brussels and Euronext Paris under the ticker symbol CYAD and
Celyad’s American Depositary Shares are listed on the NASDAQ Global
Market under the ticker symbol CYAD.
To learn more about Celyad, please
visit www.celyad.com
About NKR-T
Celyad’s lead immuno-oncology product candidate,
NKR-2, is a T-Cell encoded to express the Natural Killer activating
receptor, NKG2D. The technology developed by Celyad uses a human
natural killer cell (NK cell) receptor which, unlike traditional
CAR technologies, targeting the CD19 antigen, has the potential to
target ligands expressed on a broad range of solid tumors and blood
cancers.
The research underlying this technology was
originally conducted by Dartmouth College Professor Charles
Sentman, and has been published in numerous peer-reviewed
publications such as Journal of Immunology in 2009, Cancer Research
in 2006, and Blood in 2005. NKR-2 has an active Investigational New
Drug (IND) application with the FDA for a Phase I clinical trial in
certain hematologic cancers.
NKR-2 entered a Phase I clinical trial in April
2015. The full data readout from the Phase I dose escalation
trial is expected in mid-2016. The trial is designed to
assess the safety and feasibility of NKR-2 in acute myeloid
leukemia and multiple myeloma patients, with secondary endpoints
including clinical efficacy.
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 NKR-2 T-cell therapy and C-Cure and the clinical
potential of the Company’s technology platform generally and the
timing of future clinical trials, 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.
In particular it should be noted that the 30-day
safety data described in the release are preliminary in nature and
the Phase 1 trial is not completed. There is limited data
concerning safety and feasibility of NKR-2 T-cell therapy. These
data may not continue for these subjects or be repeated or observed
in ongoing or future studies involving our NKR-2 T-cell therapy,
C-Cure or other product candidates. It is possible that safety
issues or adverse events may arise in the future.
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 III clinical trials for C-Cure® and Phase I clinical trial
for NKR-2 T-cell; 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 prospectus filed with the SEC on June 19, 2015 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®, NKR-2 T-cell, , OnCyte,
Celyad®, Cardio3 BioSciences, C-Cathez®, 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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