CELYAD (EBR:CYAD) Celyad Announces First Quarter 2018 Business Update

Transparency directive : regulatory news

15/05/2018 22:37





Steady progress in THINK

1

, SHRINK

2


and LINK


3

trials




Regulatory News:



Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) (Paris:CYAD)
(Brussels: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
first quarter ended March 31, 2018.



FIRST QUARTER 2018 AND RECENT HIGHLIGHTS




  • Robust clinical development plan is foundation for new trials focusing
    on AML and CRC


  • Steady progress related to ongoing THINK, SHRINK and LINK trials


  • Good safety profile of CYAD-01 confirmed


  • Lead publication Haematologica publishes THINK Study Case Report



Dr. Christian Homsy, CEO of Celyad commented: “We had a
productive first quarter, further defining our strategy that will guide
CYAD-01 in becoming the foundation for cancer therapies. Not only have
we progressed in the THINK trial, we have also treated our first
patients in the SHRINK and LINK trial. The absence of any observed
critical on target/off tumor toxicity in our trials is an important
signal validating our technology. The next months will be exciting for
our company and we look forward communicating results on our clinical
trials in scientific congresses.”



FIRST QUARTER 2017 OPERATIONAL AND FINANCIAL REVIEW



In February 2018, Celyad provided a detailed clinical update summarizing
the promising results achieved in 2017: the THINK trial resulted in
signs of clinical activity ranging from Stable Disease (SD) to Complete
Response (CR), despite the absence of preconditioning therapy and the
lower doses used at that stage of the trial. The company also announced
that it will further evaluate CYAD-01 in a series of additional Phase 1
clinical trials in patients with AML and CRC.



Also in February 2018, Celyad organized a Key Opinion Leader meeting on
CAR-T therapy in New York, USA. The meeting featured a presentation by
Marco Davila, MD, PhD (Moffitt Cancer Center). The numerous attendants
received information on the unmet medical need in blood cancers as well
as details on Celyad’s clinical strategy.



On the operation side, during this first quarter, Celyad progressed well
in the THINK trial as well as the in LINK trial:



- The company dosed the three CRC patients in the third dose cohort in
the solid arm of the THINK trial, and the two last AML patients in the
second dose. Celyad plans to initiate the third dose in the AML arm in
May 2018, and complete the recruitement of three additional CRC patients
at the higher dose by mid-2018. In 2018, all patients were dosed with
the our new production process adopted in December 2017.



- The company also treated its first CRC patient in the LINK trial. This
patient received three planned injections at the first Dose level (3x108).
LINK adopts a loco-regional approach in treating CRC by administering
CYAD-01 through multiple hepatic transarterial injections.



The company ended the quarter with €25.1 million in cash, cash
equivalents and short-term investrments. Use of cash over the first
quarter of 2018 amounted to €8.8 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,
until the end of Q1 2019.



EVENTS SUBSEQUENT TO QUARTER-END:



In April 2018, Celyad’s world’s first reported complete response by a
CAR-T cell therapy in a patient with refractory and relapsed AML was
published as a case report in the leading scientific publication Haematologica.
The publication detailed the first objective response related to this
patient that is still in remission, more than 9 months after study
enrollment.



In May 2018, Celyad achieved an important milestone in its CYAD-01
clinical strategy by dosing the first metastatic CRC patients in the
LINK and SHRINK trials. No drug related toxicity was observed in the
first patients of both SHRINK and LINK trials.



Generally, Celyad’s progress is the result of the company’s clinical
development plan aiming at defining the best of three approaches for
CYAD-01 in patients with AML and CRC:



1) CYAD-01 as a stand-alone investigational therapy, currently being
evaluated in the THINK trial with relapsed refractory AML and CRC
patients. Promising results have already been reported including a
complete response and stable diseases.



Based on data as of April 5, 2018, the date of Celyad’s most recent
interim safety report for the THINK trial, Celyad had collected safety
data from 20 patients treated with CYAD-01 in the THINK trial. Of the 20
patients included in the interim safety report of the THINK trial (11
solid and nine hematologic cancer patients), Celyad reported the
following serious adverse events:




  • Grade 4 serious adverse events occurred in two patients: one patient
    in the hematologic cohort experienced respiratory failure and other
    Grade 4 adverse events after administration of dose level one of
    CYAD-01. The other patient, who was in the solid tumor cohort,
    experienced cytokine release syndrome and other Grade 4 adverse events
    after administration of dose level three of CYAD-01, which was
    adjudicated as a dose limiting toxicity (DLT).


  • Those two patients each experienced a Grade 5 event that was deemed
    unrelated to administration of CYAD-01.



2) CYAD-01 administered concurrently with standard of care treatments.
The SHRINK trial was recently initiated with the dosage of one CRC
patient in April 2018. No Grade 4 or higher adverse event has been
reported so far. This trial evaluates the concurrent administration of
CYAD-01 with the standard chemotherapy FOLFOX. We expect that another
similar trial aimed at AML patients, EPITHINK trial, will be initiated
soon.



3) CYAD-01 administered after preconditioning of the patients using
lymphodepletion. We expect trials in AML (DEPLETHINK AML) and CRC
(DEPLETHINK CRC) patients to be initiated in the coming weeks.



***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 1 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.




This press release contains inside information within the meaning of
Regulation (EU) No 596/2014 of the European Parliament and of the
Council of 16 April 2014 on market abuse (market abuse regulation).



Forward-looking statements



This release may contain forward-looking statements, including
statements regarding the proposed timing and size of the offering; our
ongoing and planned clinical development of CYAD-01; our manufacturing
processes; and our estimated cash, cash equivalents and short-term
investments at March 31, 2018. Forward-looking statements may involve
known and unknown risks, uncertainties and other factors which might
cause actual results, financial condition and liquidity, performance or
achievements of Celyad, or industry results, to differ materially from
those expressed or implied by such 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 statements about: the
initiation, timing, progress and results of our preclinical studies and
clinical trials, and our research and development programs; our ability
to advance drug product candidates into, and successfully complete,
clinical trials; our ability to successfully manufacture drug product
for our clinical trials, including with respect to manufacturing drug
product with the desired number of T cells under our clinical trial
protocols, and our ability to improve and automate these manufacturing
procedures in the future; our reliance on the success of our drug
product candidates; the timing or likelihood of regulatory filings and
approvals; our ability to develop sales and marketing capabilities; the
commercialization of our drug product candidates, if approved; the
pricing and reimbursement of our drug product candidates, if approved;
the implementation of our business model, strategic plans for our
business, drug product candidates and technology; the scope of
protection we are able to establish and maintain for intellectual
property rights covering our drug product candidates and technology; our
ability to operate our business without infringing, misappropriating or
otherwise violating the intellectual property rights and proprietary
technology of third parties; cost associated with enforcing or defending
intellectual property infringement, misappropriation or violation;
product liability; and other claims; regulatory development in the
United States, the European Union, and other jurisdictions; estimates of
our expenses, future revenues, capital requirements and our needs for
additional financing and ability to obtain such financing when needed;
the potential benefits of strategic collaboration agreements and our
ability to enter into strategic arrangements; our ability to maintain
and establish collaborations or obtain additional grant funding; the
rate and degree of market acceptance of our drug product candidates, if
approved; our financial performance; and developments relating to our
competitors and our industry, including competing therapies and
statements regarding future revenue, hiring plans, expenses, capital
expenditures, capital requirements and share performance. 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 6, 2018 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 and
Celyad’s actual results may differ materially from those expressed or
implied by these forward-looking statements. 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
THerapeutic Immunotherapy with CAR-T NKG2D



2
Standard CHemotherapy Regimen and Immunotherapy
with NKG2D



3
Loco-regional Immunotherapy with NKG2D








Celyad

Christian Homsy, CEO and Patrick Jeanmart CFO
+32(0)
10 39 41 00

investors@celyad.com

or
Nicolas
Van Hoecke, +32(0) 10 39 41 84
Director, Investor Relations &
Communications

nvanhoecke@celyad.com

or

For
France: NewCap


Pierre Laurent and Nicolas Mérigeau
+
33(0)1 44 71 94 94

celyad@newcap.eu

or

For
the U.S.: LifeSci Investor Relations


Daniel Ferry, +1 (617) 535
7746

celyad@lifesciadvisors.com