First clinical trial of NKR-2 T-cells therapy
completed with good safety outcome and unexpected signals of
clinical activity at the low doses tested
Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of engineered cell therapies, today
provides an update on key clinical and operational developments
over the three-month period ended 30 September 2016.
HIGHLIGHTS OF THE THIRD
QUARTER
- Strategic License agreement with ONO PHARMACEUTICAL CO., LTD,
Japan, to develop allogeneic NKR-2 T-cell immunotherapy.
- Completion of the autologous NKR-2 Phase I trial conducted at
the Dana Farber Cancer Institute in Boston, USA, with successful
safety follow-up.
- NKR-2 safety data demonstrating encouraging results to be
presented early December at the American Society of Hematology
(ASH) Annual Meeting
- Reinforcement of the corporate management team with the
appointment of Philippe Dechamps as Chief Legal Officer.
Dr. Christian Homsy, CEO of Celyad
commented: "The third quarter of 2016 saw us increase our
focus on the development of our NKR-T platform in line with our
strategy. We continued to deliver on our development objectives for
NKR-2 and reached important safety outcomes with the successful
completion of our Phase I trial. We also saw reports of
unexpected clinical benefits which were encouraging. We now look
forward to reporting the outcome of this trial at ASH in December,
and starting THINK, our multiple dosing umbrella trials testing
NKR-2 in five solid and two blood malignancies."
Patrick Jeanmart, CFO at Celyad,
added: "Thanks to the first payment associated to the ONO
partnership and a strong management of our operational cash drain,
we ended the third quarter of 2016 with EUR 87 million. This cash
position will allow the Group to finance all of its operations and
clinical development program until the middle of 2019."
OPERATIONAL AND FINANCIAL
REVIEW
Over the third quarter, Celyad has made
significant progress in the preclinical and clinical development of
its NKR-T platform with the completion of the autologous NKR-2
Phase I trial. This study was completed in September 2016 with a
successful safety follow-up for all dose level cohorts. There were
no cases of cytokine release syndrome, cell-related neurotoxicity,
auto-immunity, or CAR-T related death. Furthermore, some unexpected
clinical activity was observed while testing a single infusion
dosed between 50 and 1,000 times lower than our expected
efficacious dose extrapolated from animal experiments. The NKR-2
Phase I trial was a single infusion, dose escalation study
evaluating the safety and feasibility of NKR-2 T-cells in Acute
Myeloid Leukemia and Multiple Myeloma patients. Full data readout
is confirmed to take place at the ASH conference early
December in San Diego.
In July, Celyad entered into an exclusive
license agreement with the Japanese company ONO PHARMCEUTICAL CO.,
LTD, one of the global leaders in the immuno-oncology field, for
the development and commercialization of Celyad's allogeneic NKR-2
T-cell immunotherapy in Japan, Korea and Taiwan. 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). In exchange for granting ONO
an exclusive license in these territories, ONO will pay Celyad a
$12.5 million-dollar upfront payment, up to $299 million in
additional milestones and a double-digit royalty based on the net
sales of the licensed product in ONO's territory. Both companies
will also explore the opportunity to collaborate to collectively
run global registration trials and combination trials. In addition,
Celyad has also granted to ONO an exclusive option to license for
development and commercialization of its autologous NKR-2 T cell
product in the above ONO territories.
In August, Celyad presented the primary clinical
data of CHART-1 Phase III trial at the European Society of
Cardiology. Though the primary endpoint of the study was not
reached, a positive trend was seen across all treatment groups, and
the primary endpoint was met (p=0.015) for a subset representing
60% of the population of the CHART-1 study (baseline End Diastolic
Volume (EDV) segmentation). In this subgroup, a statistical
significant positive difference was seen in all individual elements
of the composite primary endpoint (Mortality, Worsening Heart
Failure Events, Quality of Life, 6 minutes Walking Test, End
Systolic Volume and Ejection Fraction). Based on these results,
Celyad has initiated business development activities seeking a
partner who would pursue the further development and
commercialization of the therapy C-Cure®.
Also in August, Mr. Danny Wong resigned amicably
from Celyad's Board of Directors in order to concentrate on his
investments in Asia.
In September, Celyad reinforced its management
team with the appointment of Philippe Dechamps as Chief Legal
Officer.
The Company ended the quarter with €87 million
in cash including the first payment of €10 million from ONO.
Use of cash over the quarter amounted to €9 million. The Company
believes that existing cash and cash equivalents and short term
investments are sufficient to fund operating expenses and capital
expenditure requirements, based on the current scope of activities,
until the middle of 2019.
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 CAR-T product candidates using Natural Killer
Receptor transduced on T cells (NKR-T) platform has the potential
to treat a broad range of solid and liquid tumors. Its lead
oncology candidate, 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.
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.
For more information about Celyad, please visit:
www.celyad.com
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 |
CelyadChristian Homsy, CEO and
Patrick Jeanmart, CFO: T:
+32 (0)10 39 41 00
investors@celyad.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 NKR-2 T-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 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, 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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