Regulatory News:
Celyad (Paris:CYAD) (Brussels:CYAD) (Euronext Brussels and
Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical
company focused on the development of specialized CAR-T cell based
therapies, today provided an update on key clinical and operational
developments for the third quarter ended Sept. 30, 2017.
THIRD QUARTER 2017 AND RECENT HIGHLIGHTS
- Reported first complete response by a
CAR-T therapy in a patient with relapsed refractory AML (Acute
Myeloid Leukemia) in the Phase 1b THINK1 trial
- Reported promising safety and clinical
activity of CYAD-01 (CAR-T NKG2D) in all AML patients treated so
far in THINK trial
- Announced amended agreements with
Celdara Medical and Dartmouth College following encouraging results
from the THINK trial
- Initiated the Phase 1 SHRINK2 study in
Belgium to evaluate the synergetic effect of the concurrent
administration of CYAD-01 with standard chemotherapy in patients
suffering from metastatic colorectal cancer
Christian Homsy, CEO of Celyad commented: “We are
pleased with our progress during the third quarter, particularly
with the complete response in a relapse refractory AML patient to
the CYAD-01 therapy in our THINK trial. This, together with the
clinical activity detected in all AML patients treated so far
encourages us to rapidly progress in our development. Having seen
this activity, we want to build upon it and explore how to
strengthen it and make it more robust. The research steps are
behind us now, and the development strategy we are engaged in will
investigate approaches that will both strengthen the responses and
make them more durable, when needed.”
The clinical responses obtained by Celyad are perceived as a key
milestone not only for the company, but also for the CAR-T field as
a whole, as this is the first time that a patient has shown a
complete response to a CAR-T therapy without pre-conditioning.
Christian Homsy added: “The results validate CYAD-01 and
NKG2D as a target in AML, a severe disease that affects
approximately 20,000 people in the US and almost as many people in
Europe. Celyad will further investigate CYAD-01 in this indication
as well as in colorectal cancers, an indication for which CYAD-01
has also demonstrated interesting results.”
THIRD QUARTER 2017 OPERATIONAL AND FINANCIAL REVIEW
In July 2017, Celyad initiated the SHRINK trial, an open-label
Phase 1 study evaluating the safety and clinical activity of
multiple doses of CYAD-01, administered concurrently with the
neoadjuvant FOLFOX treatment in patients with potentially
resectable liver metastases from colorectal cancer. The trial
includes a dose escalation and an extension stage. The dose
escalation design will include three dose levels adjusted to body
weight: up to 1x108, 3x108 and 1x109 CYAD-01 cells. At each dose,
patients will receive three successive administrations, two weeks
apart, at the specified dose. The dose escalation portion of the
study will enroll up to 18 patients and the extension phase will
enroll 21 additional patients. SHRINK is being conducted in
oncology centers in Belgium.
In August 2017, Celyad amended its existing agreements with
Celdara Medical LLC and Dartmouth College. Under the amended
agreements, Celyad will receive an increased share of future
revenues generated by these assets, including revenues from its
sublicensees. In return, Celyad paid Celdara Medical and Dartmouth
College an upfront payment of $12.5 million (€10.6 million) and
$12.5 million worth of Celyad shares at a share price of €32.35
corresponding to a 14% premium versus the prior trading day.
Patrick Jeanmart, CFO of Celyad, added, “Our revised
agreements with Celdara Medical and Dartmouth College reflect our
strong belief in the value-creating potential of our allogeneic
CAR-T cell patent portfolio and our ongoing confidence in CYAD-01.
By shifting some of the value of the original deal upfront, we have
increased our share of potential future revenues from
sublicenses.”
The Company ended the quarter with €40 million in cash. Use of
cash over the third quarter of 2017 amounted to €29 million, of
which €18 million paid to Celdara Medical and Dartmouth College as
a result of our new license agreements. The cash burned by our
operations was €11 million over the third quarter and €27 million
over 2017, in line with our expectations. The company confirms its
previous guidance, that existing cash, cash equivalents and
short-term investments are sufficient to fund operating expenses
and capital expenditure requirements, based on the current scope of
activities, through to the first half 2019.
EVENTS SUBSEQUENT TO QUARTER-END
In October 2017, Celyad announced a first ever morphologic
complete response (MLFS3) with gene-engineered T-cells without
prior pre-conditioning chemotherapy for a patient with relapsed
refractory AML. At the first dose-level, 3x108, CYAD-01 T-cells
were administered without any prior conditioning chemotherapy to a
cohort of three patients with hematologic cancer (two with AML and
one with multiple myeloma): One AML patient achieved a MLFS
administered at the H. Lee Moffitt Cancer Center and Research
Institute in Tampa, Florida. A second AML patient treated also
reached a Complete Response (CR) and more precisely a Complete
Response with incomplete hematologic recovery. Unlike the patient
that reached MLFS, this second patient progressed after a while and
has since moved to another treatment.
The first AML patient treated at the second dose-level (1x109)
was reported as Stable Disease with improvement of his
hematological parameters at 2-month follow-up post treatment.
To date, all AML patients have shown varying clinical responses
that are attributed to the CYAD-01 treatment.
***END***
About Celyad
Celyad is a clinical-stage biopharmaceutical company focused on
the development of specialized CAR-T cell based therapies. Celyad
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, CYAD-01 (CAR-T NKG2D), has
been evaluated in a single dose escalation Phase I clinical trial
to assess the safety and clinical activity of multiple
administrations of autologous CYAD-01 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).
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 the NASDAQ Global
Market, all under the ticker symbol CYAD.
For more information, 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
CYAD-01 cell therapy, including current and planned preclinical and
clinical trials for Celyad’s product candidates; the clinical and
commercial potential of these product candidates and the adequacy
of Celyad’s financial resources; Celyad’s intellectual property
portfolio, including plans related thereto; Celyad’s expectations
regarding its strategic collaborations and license agreements with
third parties, including Novartis, Celdara Medical, and Dartmouth
College, and the potential impact of such collaborations on
Celyad’s future financial condition; and Celyad’s expected cash
burn, which reflect Celyad’s 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 and risks, 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 trials
or preclinical studies may not be replicated in subsequent trials
or studies; risks associated with the timely submission and
approval of anticipated regulatory filings; the successful
initiation and completion of clinical trials, including its
clinical trials for CYAD-01; 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, Celyad’s ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; risks associated with competition
from others developing products for similar uses; risks associated
with Celyad’s ability to manage operating expenses; and risks
associated with Celyad’s ability to obtain additional funding to
support its 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 Celyad’s U.S. Securities and Exchange Commission
(SEC) filings and reports, including in its Annual Report on Form
20-F filed with the SEC on April 4, 2017 and subsequent filings and
reports by Celyad. 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. Celyad 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.
1 THINK: THerapeutic Immunotherapy with CAR-T
NKG2D2 SHRINK: Standard CHemotherapy
Regimen and Immunotherapy with CAR-T NKG2D3
MLFS « Morphological Leukemia-Free Status »
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version on businesswire.com: http://www.businesswire.com/news/home/20171116006162/en/
CelyadChristian Homsy, CEO and Patrick Jeanmart CFO - T:
+32(0) 10 39 41 00investors@celyad.comorNicolas Van Hoecke,
Director, Investor Relations & Communications - T: +32(0) 10 39
41 48nvanhoecke@celyad.comorFor Europe: Consilium Strategic
CommunicationsChris Gardner and Chris Welsh - T: +44 (0)20 3709
5700celyad@consilium-comms.comorFor France: NewCapPierre
Laurent and Nicolas Mérigeau - T: + 33(0)1 44 71 94
94celyad@newcap.euorFor Belgium: ComfiGunther De Backer and
Sabine Leclercq - T.: +32 (0)2 290 90 90celyad@comfi.beorFor the
U.S.: Stern Investor RelationsWill O’Connor and Michael
Schaffzin – T.: +1 212.362.1200celyad@sternir.com
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