Increase of current tested dose levels from
6.25x104/kg to 2.5x105/kg
Treatment interval shortens between patients
from 42 days to 28 days, then to 14 days for subsequent
patients
MD Anderson Cancer Center added as new
clinical site for the AML study
Regulatory News:
This replaces the announcement made at 22:30 CEST on 22 May 2018
due to the following addendum:
More information has been added to the first bullet point after
the second paragraph
Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a
clinical-stage biopharmaceutical company focused on developing
immunotherapies based on gene-edited allogeneic CAR T-cells
(UCART), announced today the approval of an amendment to the
protocol for the Phase 1 clinical trial of Cellectis’ UCART123
product candidate in patients with acute myeloid leukemia
(AML).
The main changes to the protocol include:
- Dose level 1 to be administered
increases from 6.25x104 to 2.5x105 UCART123 cells per kilogram.
Dose levels 2 and 3 are now respectively at 6.25x105 and 5.05x106.
Dose level -1 is now at 1.25x105. The product’s safety and
tolerability profile allowed Cellectis to increase dose levels with
a capping at 80kg equivalent.
- The dose limiting toxicities (DLT)
observation period decreases from 42 to 28 days post-UCART123
infusion, except for patients with aplastic bone marrow at Day 28
for whom the DLT observation period remains 42 days.
- The time interval between the first and
the second patient for UCART123 infusion at each new dose level
tested shortens from 42 days to 28 days (42 days in case of
aplastic anemia) then to 14 days for subsequent patients.
- A potential second UCART123 infusion is
implemented.
In addition, a new AML clinical center has been opened at MD
Anderson Cancer Center in Houston, Texas, aiming at increasing the
patient enrollment pace. The study is led by Prof. Hagop
Kantarjian, MD, Department Chair, Department of Leukemia, Division
of Cancer Medicine, and Dr. Naveen Pemmaraju, MD, Assistant
Professor, being Principal Investigator.
“This amendment approval for Cellectis’ UCART123 protocol is an
important step in the progression of our study, and opening another
clinical site at MD Anderson – one of the world’s most premier
cancer centers – puts the Company on solid ground to help as many
AML patients as possible with this innovative new therapy,” said
Prof. Stéphane Depil, Senior Vice President, R&D, and Chief
Medical Officer at Cellectis. “Off-the-shelf gene editing
immunotherapy is continuing to revolutionize the landscape of
modern medicine, and we hope that this approach leads to a
lifesaving treatment for AML patients in the near future.”
“As Cellectis has been working very closely with the concerned
parties to review the details of UCART123 study to date, we are
eager to hit the ground running with the new protocol in an effort
to find a truly effective treatment for AML patients with high
unmet medical needs,” added Stéphan Reynier, Chief Regulatory and
Compliance Officer at Cellectis. “We look forward to obtaining
additional data so that we can address such a rare and devastating
disease.”
The FDA review period for this protocol amendment has passed and
Cellectis obtained IRB’s approval.
More information about this trial is available at
ClinicalTrials.gov.
About UCART123 clinical trial
Our first wholly controlled product candidate, UCART123, is a
gene edited T-cell investigational drug that targets CD123, an
antigen expressed at the surface of leukemic cells in AML.
Cellectis received in February 2017 an Investigational New Drug
(IND) approval from the U.S. Food and Drug Administration (FDA) to
conduct Phase 1 clinical trial with UCART123 in patients with AML.
This marks the first allogeneic, “off-the-shelf” gene-edited CAR
T-cell product candidate that the FDA has approved for clinical
trial.
UCART123 clinical trial in AML is a Phase 1, open label
dose-escalation and dose-expansion study to evaluate the safety,
expansion, persistence and clinical activity of UCART123
(allogeneic engineered T-cells expressing anti-CD123 chimeric
antigen receptor), administered in patients with
relapsed/refractory AML, and patients with newly diagnosed
high-risk AML.
The clinical research is coordinated by principal investigator
Prof. Gail J. Roboz, MD, at Weill Cornell, Professor of Medicine at
Weill Cornell Medicine and Director of the Clinical and
Translational Leukemia Programs at Weill Cornell Medicine and
NewYork-Presbyterian.
AML is a devastating clonal hematopoietic stem cell neoplasm
that is characterized by uncontrolled proliferation and
accumulation of leukemic blasts in bone marrow, peripheral blood
and, occasionally, in other tissues. These cells disrupt normal
hematopoiesis and rapidly cause bone marrow failure and death. In
the U.S. alone, there are in 2017 an estimated 21,000 new AML cases
per year, with 10,000 estimated deaths per year.1
About Cellectis
Cellectis is a clinical-stage biopharmaceutical company focused
on developing a new generation of cancer immunotherapies based on
gene-edited T-cells (UCART). By capitalizing on its 18 years of
expertise in gene editing – built on its flagship TALEN® technology
and pioneering electroporation system PulseAgile – Cellectis uses
the power of the immune system to target and eradicate cancer
cells.
Using its life-science-focused, pioneering genome engineering
technologies, Cellectis’ goal is to create innovative products in
multiple fields and with various target markets.
Cellectis is listed on the Nasdaq market (ticker: CLLS) and on
Euronext Growth (ticker: ALCLS). To find out more about us, visit
our website: www.cellectis.com
Talking about gene editing? We do it. TALEN® is a registered
trademark owned by Cellectis.
Disclaimer
This press release contains “forward-looking” statements that
are based on our management’s current expectations and assumptions
and on information currently available to management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Further information on the risk
factors that may affect company business and financial performance
is included in Cellectis’ Annual Report on Form 20-F and the
financial report (including the management report) for the year
ended December 31, 2017 and subsequent filings Cellectis makes with
the Securities Exchange Commission from time to time. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
###
1 National Cancer Institute (NCI), https://seer.cancer.gov
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version on businesswire.com: https://www.businesswire.com/news/home/20180522006453/en/
For further information, please contact:Media
contacts:Jennifer Moore, 917-580-1088VP of
Communicationsmedia@cellectis.comorCaitlin Kasunich,
212-896-1241KCSA Strategic Communicationsckasunich@kcsa.comorIR
contact:Simon Harnest, 646-385-9008VP of Corporate Strategy and
Financesimon.harnest@cellectis.com
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