Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a
leader in the discovery and development of cell therapies, today
provided an update on key clinical and operational developments for
the first quarter ended March 31, 2017.
FIRST QUARTER 2017 AND RECENT
HIGHLIGHTS
- Initiation of the THINK trial in Belgium and the US in patients
with both hematological and solid tumors
- No drug related safety issues reported to date
- USPTO upholds Celyad’s U.S. patent related to allogeneic
TCR-deficient CAR-T cells
- In May 2017, granted Novartis a non-exclusive license for its
allogeneic TCR-deficient CAR-T cells patents
Dr. Christian Homsy, CEO of Celyad
commented: “Celyad had a productive first quarter, setting
the tone for the remainder of 2017. Our continued focus on our
NKR-T platform has led to important milestones: the initiation of
the U.S. arm of our THINK trial, the successful and safe dosing of
our first patients with solid, bone marrow and hematological tumors
and the demonstration of the safety of our CAR-T NKR-2 product at
the first dose tested.”
Patrick Jeanmart, CFO of Celyad
added: “The decision of the USPTO to uphold our patent
related to allogeneic TCR-deficient CAR-T cells confirmed the
strength of our intellectual property, and our license agreement
with Novartis demonstrated the intrinsic value of this asset.”
FIRST QUARTER 2017 OPERATIONAL AND
FINANCIAL REVIEW
In January, the U.S. Patent and Trade Office
(USPTO) decided –for the third time – to uphold 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. In
March, the USPTO rejected another request for a re-examination of
the same patent. Celyad’s critical patent remains valid and
enforceable.
On the operation side, the THINK trial
progressed as expected. The ongoing THINK trial is comprised of two
arms: a solid tumor arm, targeting colorectal, pancreatic, ovarian,
triple negative breast and bladder cancers, and a liquid arm,
targeting Acute myeloid leukemia (AML) and multiple myeloma (MM).
All patients in the first dose (3x108) cohort of the solid tumor
arm of the trial were dosed successfully with no drug related
safety issues reported. The first cohort is composed of two
colorectal and one pancreatic patient. In the liquid tumor arm, the
first AML patients have been dosed and two MM patients have been
recruited.
With consent from the U.S. Food and Drug
Administration (FDA) in March, the THINK trial is now global,
recruiting patients both in Belgium and in the U.S. In the US,
Celyad intends to recruit patients at three clinical centers, two
of which have been initiated and approved (Roswell Park (NY) and
University of Pittsburgh Medical Centre (PA)).
The Company ended the quarter with €72.4 million
in cash. Use of cash over the first quarter of 2017 amounted to
€10.2 million, in line with expectations. The company confirms 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, through the
first half 2019.
EVENTS SUBSEQUENT TO
QUARTER-END:
On April 28, Celyad announced the dosing of the
first patient of the second dose (1x109) in the solid tumor arm of
its THINK trial. This first ovarian cancer patient was dosed at
Roswell Park Cancer Institute (Buffalo, New York).
On May 2, Celyad announced a non-exclusive
license agreement with Novartis for Celyad’s US patents related to
allogeneic CAR-T cells. This license agreement is related to two
targets currently under development by Novartis. The agreement
includes Celyad’s intellectual property rights under United States
Patent No. 9,181,527 related to allogeneic human primary T-Cells
that are engineered to be T-Cell Receptor (TCR) deficient and
express a Chimeric Antigen Receptor (CAR).
Under the terms of the agreement Celyad receives
an upfront payment and is eligible to receive success based
clinical, regulatory and commercial milestone payments. If all
success based milestones are achieved, Celyad is eligible to
receive payments, including the upfront payment, totalling $96
million. In addition, Celyad will receive single digit royalties
based on net sales of the licensed target associated products.
Novartis has the option to extend the agreement to additional
targets and/or to convert its license into an exclusive license.
Celyad retains all rights to grant further licenses to third
parties for the use of allogeneic CAR-T cells.
Celyad will not be involved in the development
of Novartis’ CAR-T cells. Celyad will continue to focus on the
development of its CAR-T pipeline, including its allogeneic NKR-2
T-cell immunotherapy in the EU and US territories and in
collaboration with Ono Pharmaceuticals, its partner in Japan,
Taiwan and Korea.
On May 11, Celyad announced that the FDA had
granted Fast Track designation for its C-Cure® therapy. Celyad
intends to leverage this designation to accelerate the search for a
strategic partner. The FDA granted Fast Track designation for
reduction in mortality, hospitalization and improvement of quality
of life in patients with chronic heart failure secondary to
ischemic cardiomyopathy with baseline Left Ventricular
End-Diastolic Volumes (LVEDV) between 200 and 370ml as Fast Track
Development Program.
About CelyadCelyad is a
clinical-stage biopharmaceutical company focused on the development
of specialized cellbased 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.
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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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