- Celyad grants an exclusive license to ONO for the development
and commercialization of Celyad's unique allogeneic NKR-2 T-cell in
Japan, Korea and Taiwan.
- Celyad also grants to ONO an exclusive option to license its
autologous NKR-2 T cell product in the above ONO territories.
- Total deal value of up to 31.325 JPY B (€282 million or $311.5
million) plus double digit royalties on net sales in ONO
territories.
Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of cell therapies, today announced an
exclusive license agreement with the leading Japanese
immuno-oncology company, ONO Pharmaceutical Co., Ltd. (TSE: 4528),
for the development and commercialization of Celyad's allogeneic
NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This license
agreement opens new markets to Celyad and expands the global
footprint of its NKR-2 T-cell cancer immunotherapy treatment and
potentially for other disease conditions.
Celyad will receive an upfront payment of 1.25 JPY B (€11.25
million or $12.5 million) and is eligible of up to 30.075 JPY B
(€270.75 million or $299 million) in development and commercial
milestones. Celyad will also receive double digit royalties based
on net sales of the licensed product in ONO's territories.
Under the terms of the agreement, Celyad will continue
developing its allogeneic NKR-2 T-cell immunotherapy in the EU and
US territories, and ONO will be responsible for future development
and commercialization in ONO's territories (Japan, Korea and
Taiwan). Both companies will also explore the opportunity to
collaborate to collectively run global registration trials and
combination trials. In addition, Celyad grants to ONO an exclusive
option to license for development and commercialization of its
autologous NKR-2 T cell product in the above ONO territories.
Dr. Christian Homsy, CEO of Celyad, said: "We are very
pleased to collaborate with ONO and to activate the development of
our NKR-2 T-cell allogeneic platform in Japan, Korea and Taiwan.
This license agreement is a great opportunity for Celyad to expand
the scope of its immuno-oncology clinical programs and bring this
breakthrough science to numerous patients around the world.
Further, this license agreement with ONO, the leader in
immuno-oncology in Asia, validates our NKR-2 approach and its
tremendous potential."
Georges Rawadi, VP Business Development of Celyad, said:
"Celyad surrounds itself with the best immuno-oncology experts in
the world to develop its NKR T-cell platform. This is why we have
entered this agreement with ONO. Through this commercial license
agreement, Celyad aims to expand the clinical and commercial
potential of its allogeneic NKR-2 T-cell immunotherapies
worldwide."
Gyo Sagara, President, Representative Director
and CEO of ONO, said: "We are very delighted to collaborate
with the leading cell therapy company, Celyad, for its distinct
immuno-oncology candidates. Celyad's NKR-2 is backed by
cutting-edge science and we believe that it can be a new
therapeutic option for patients who are not cured with existing
therapies."
Conference Call Details
A conference call will be held on Monday, July 11,
2016 at 2:00pm (CEST) / 8:00am (EDT) to review the licensing
agreement with ONO Pharmaceutical. Christian Homsy, Chief Executive
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 dialing the numbers
below and using the passcode: 30423803
International:
+44 (0) 1452 584233
Belgium:
024003425
France:
0800947325
UK:
08002795994
US:
1 866 629 0057
About Celyad's NKR Platform
Celyad is developing a unique Natural Killer Receptor (NKR)
based T-Cell platform to target 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 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 mechanism
of actions and goes beyond direct killing by signifying that its
encoded T-Cells attack the tumor cells, inhibit the mechanisms that
enable tumors to evade the immune system, activate and recruit
anti-tumor immune cells and disrupt 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.
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.
NKR-2 is currently being tested in a Phase I trial in acute
myeloid leukemia and multiple myeloma patients. The trial is
designed to assess the safety and feasibility of NKR-2, with
secondary endpoints including clinical activity. Key research
investigations include understanding the persistence of NKR-2 cells
within the patient.
About ONO PHARMACEUTICAL CO., LTD.
ONO PHARMACEUTICAL CO., LTD., headquartered in Osaka, Japan, is
an R&D-oriented pharmaceutical company committed to create
innovative medicines in specific areas. It focuses especially on
the oncology and diabetes areas. For more information, please visit
the company's website at http://www.ono.co.jp/eng/index.html
***END***
For more information, please contact:
For Europe: Consilium Strategic Communications Chris
Gardner,Chris Welsh, and Laura Thornton -
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 - T.: +32 (0)2 290
90 90 - gunther@comfi.be |
Celyad Christian Homsy, CEO and Patrick
Jeanmart, CFO : T :
+32 (0)10 39 41 00
investors@celyad.com |
ONO
Pharmaceutical Co., Ltd. Corporate Communications
public_relations@ono.co.jp |
To subscribe to Celyad's newsletter,
visit www.celyad.com Follow us on Twitter
@CelyadSA and on LinkedIn
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 (NKR) based T-Cell platform has the
potential to treat a broad range of solid and liquid tumors. Its
lead oncology candidate, NKR-2, is currently being evaluated in a
Ph I/II clinical trial. In addition, Celyad has completed a Phase
III trial in the EU for its C-Cure cardiovascular disease candidate
in ischemic heart failure.
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.
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 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. These data may not continue for these
subjects or be repeated or observed in ongoing or future studies
involving our NKR-2 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;
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, NKG2D CAR T-cell, 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.
HUG#2027580
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Celyad Oncology (EU:CYAD)
Historical Stock Chart
From Jul 2023 to Jul 2024