Full Press Release Details
Reports Financial Results for 2nd
Quarter and First Six Months 2018
approves UCART123 protocol amendment to accelerate clinical
development in AML patients
approves IND for UCART22 in B-ALL patients, which is the 3rd
allogeneic gene-edited CAR T-cell product candidate approved for
clinical trials in the United States
and Servier alliances to accelerate commercialization of allogeneic
CAR T-Cell therapies
follow-on offering by Cellectis and $61M follow-on offering by Calyxt1
position of $491M is expected to fund operations until 2022
NEW YORK--(BUSINESS WIRE)--August 1, 2018--Regulatory News:
Cellectis S.A. (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage
biopharmaceutical company focused on developing immunotherapies based on
gene-edited allogeneic CAR T-cells (UCART), today announced its results
for the three-month period ended June 30, 2018 and for the six-month
period ended June 30, 2018.
During the first half of 2018 Cellectis worked to speed up the clinical
development of its allogeneic CAR T-cell product candidates. An
amendment to the UCART123 Phase 1 protocol for AML enables the
acceleration of the development of this product candidate. We received
approval for our IND application for UCART22 in B-ALL and this UCART22
clinical trial is expected to start recruiting patients in the second
half of this year. UCART22 is the third allogeneic CAR T-cell product
candidate developed by Cellectis to enter the clinic. With the closing
of our recent follow-on offering, we strengthened Cellectis' shareholder
base and secured financing for Cellectis to develop and manufacture more
fully owned product candidates, to establish commercial capabilities,
seek marketing approvals through the filing of one or more Biologics
License Applications and pursue other critical milestones for one or
more of our current product candidates.
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1 Including an $8.3 million investment from Cellectis.
Cash position includes cash, cash equivalent and current financial
Second Quarter 2018 and Recent Highlights
In May, the FDA approved an amendment to the protocol for the Phase 1
clinical trial of Cellectis' UCART123 product candidate in patients with
acute myeloid leukemia (AML). The amendment allows an immediate 4x
increase of current dose level 1 from 6.25x104 to 2.5x105
UCART123 cells per kilogram and increases dose levels 2 and 3 to 6.25x105
and 5.05x106 UCART123 cells per kilogram, respectively.
The treatment interval was shortened from 42 days to 28 days between the
first 2 patients at each new dose tested (42 days only in case of
aplastic bone marrow), and then to 14 days for the subsequent patients.
The new protocol also allows for a potential second infusion of
UCART123. The MD Anderson Cancer Center has been added as new clinical
site for the AML study in addition to Weill Cornell Medical Center.
In June, the FDA approved Cellectis' Investigational New Drug (IND)
application to initiate a Phase 1 clinical trial for UCART22, Cellectis'
second wholly controlled TALEN gene-edited product candidate, for the
treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult
patients. UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR
T-cell product candidate developed by Cellectis to be approved by the
FDA for clinical trials in the United States. UCART22 is designed to
target and kill CD22 expressing cells. Like CD19, CD22 is a cell surface
antigen expressed from the pre-B-cell stage of development through
mature B-cells and is expressed in more than 90% of patients with B-ALL.
Approximately 85% of ALL cases involve precursor B-cells (B-ALL).
Cellectis intends to begin the UCART22 Phase 1 study in the second half
of 2018. The clinical research for UCART22 will be led by Dr. Nitin
Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the
Department of Leukemia and University Chair in Cancer Medicine, at The
University of Texas MD Anderson Cancer Center in Houston.
UCART19 and Corporate Collaboration
In April, Allogene Therapeutics, Inc. ("Allogene"), a new biotechnology
company co-founded by Dr. Arie Belldegrun and Dr. David Chang, the
former CEO and CMO of Kite Pharma, Inc., respectively, announced that it
has entered into an asset contribution agreement with Pfizer, Inc.
("Pfizer"), pursuant to which Allogene purchased Pfizer's portfolio of
assets related to allogeneic CAR T-cell therapy, including the Research
Collaboration and License Agreement dated June 17, 2014 (as amended from
time to time, the "Collaboration Agreement") signed between Pfizer and
Cellectis. Cellectis remains eligible to receive clinical and commercial
milestone payments of up to $2.8 billion, or $185 million per target for
15 targets, and tiered royalties in the high single digits on net sales
of any products that are commercialized by Allogene under the
Collaboration Agreement. As part of the transaction, Allogene has also
received Pfizer's rights to UCART19, which were sub-licensed to Pfizer
by Les Laboratoires Servier ("Servier"), which has an exclusive license
to UCART19 from Cellectis under the Product Development, Option, License
and Commercialization Agreement between Servier and Cellectis dated as
of February 17, 2014 (the "Servier Agreement").
In April, Cellectis closed a follow-on offering of 6,146,000 American
Depositary Shares ("ADS") at a public offering price of $31.00 per ADS
resulting in gross proceeds of $190.5 million. In May, Calyxt closed a
follow-on offering of 4,057,500 ADS at a public offering price of $15.00
per ADS resulting in gross proceeds of $60.9 million. Cellectis
purchased 550,000 shares of common stock at the public offering price of
In June, Cellectis reported the publication of a study in Scientific
Reports, a Nature Publishing Group journal, describing the
development of the CubiCAR, an all-in-one Chimeric Antigen Receptor
(CAR) architecture with an embedded multi-functional tag for
purification, detection and elimination of CAR T-cells. This added
versatility has the potential to streamline the manufacturing of CAR
T-cells to allow their tracking and efficiently eliminate CAR T-cells in
clinical settings. This novel architecture was developed through a
collaboration of Cellectis and Allogene researchers.
Academic Collaboration
In May, Cellectis and the Wyss Institute for Biologically Inspired
Engineering at Harvard University announced that they will collaborate,