Full Press Release Details
Quarter and Full Year 2017 Financial Results
dose cohort of PhI intermediary data of UCART19 presented at ASH in
December 2017, showing 83% CR rate in 12 high tumor burden ALL
manufacturing of UCART22, representing already the third allogeneic,
off-the-shelf, TALEN gene-edited CAR T-Cell campaign after UCART19
patient enrolment resumed in December for both Ph1 trials in acute
myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell
neoplasm (BPDCN), following the lift of the clinical hold by the FDA
multiplexed gene editing efficiency presented using TALEN in T-Cells
with simultaneous double knock-out and double knock-in achieved at
IPO of Calyxt in July, with gross proceeds of $64.4 million to Calyxt;
Cellectis retains 79.3% ownership as of February 28, 2018.
position of $297 million as of December 31, 2017, compared to $291
million as of December 31, 2016
NEW YORK--(BUSINESS WIRE)--March 12, 2018--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (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 its results for the three-month period ended December
31, 2017 and for the year ended December 31, 2017.
"I would like to highlight what remarkable progress we made in 2017, by
transforming the off-the-shelf CAR T-cell concept into reality. I
believe I can say without a doubt that we have only just scratched the
surface of what a powerful treatment CAR T-cell therapy represents. 2018
will be a turning point for Cellectis, extending our lead in the
allogeneic CAR T-cell field," said Andr Choulika, Chairman and Chief
Executive Officer, Cellectis.
1 Cash position includes cash, cash
equivalents and current financial assets.
Earnings Call Details
Cellectis to hold a conference call for investors on Tuesday, March 13,
2018 at 8 a.m. EDT - 1 p.m. Paris Time. The call will include the
company's fourth quarter 2017 and year-end financial results.
The live dial-in information for the conference call is:
US & Canada only: 877-407-3104
International: 201-493-6792
In addition, a replay of the call will be available for 6 months
following the conference by calling 877-660-6853 (Toll Free US &
Canada); 201-612-7415 (Toll Free International).
The archived webcast of this event will be available archived for 6
Cellectis - Therapeutics
UCART19: TALEN gene-edited, allogeneic CAR T-Cell product
candidate in ALL patients, exclusively licensed to Servier
Intermediary results from the two Phase I clinical trials of UCART19
were presented by Servier at the 59th American Society of Hematology
(ASH) Annual Meeting and Exposition in Atlanta. UCART19 is an
investigational allogeneic anti-CD19 CAR T-cell product candidate, used
in adult and pediatric patients with relapsed or refractory (R/R)
CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). These
first-in-human data demonstrated the safety and tolerability of UCART19,
resulting in an 83% complete remission rate across the adult and
pediatric patient populations at day 28 post CAR T-cell infusion. Our
commercial partner Servier is currently expanding the UCART19 clinical
studies in multiple centers in the U.S. and Europe and we are expecting
further clinical updates by year-end 2018.
Additional results from the two Phase I clinical trials with UCART19
will be presented on March 21, 2018 during the European society for
Blood and Marrow Transplantation (EBMT) Annual Meeting to be held in
Successful GMP manufacturing of UCART22, representing already the
third allogeneic, off-the-shelf, TALEN gene-edited CAR T-cell campaign
after UCART19 and UCART123
UCART22 is currently in GMP manufacturing, expected to yield clinical
supplies for the planned Ph1 study in ALL patients. Pending the
completion of the manufacturing campaign, Cellectis plans to file an
Investigational New Drug (IND) application in the first half of 2018.
The UCART22 manufacturing campaign represents already the third
consecutive manufacturing campaign of a TALEN gene-edited CAR T-cell
campaign after UCART19 and UCART123, positioning Cellectis as a leader
in the allogeneic, off-the-shelf CAR T-cell space.
UCART123: Cellectis' TALEN gene-edited, allogeneic CAR T product
candidate in AML and BPDCN Patients
In December 2017, patient enrollment has resumed in both Phase I
clinical trials of UCART123 in acute myeloid leukemia (AML) and blastic
plasmacytoid dendritic cell neoplasm (BPDCN). On November 6, 2017,
Cellectis announced that the U.S. Food and Drug Administration (FDA) has
lifted the clinical hold, previously announced on September 4, 2017, on
both Phase I trials of UCART123. In connection with the lifting of the
clinical hold, Cellectis agreed with the FDA to certain revisions to be
implemented in Phase I UCART123 protocols.
Cellectis announced on December 4, 2017 the appointments of Ms. Elsy
Boglioli to the role of Executive Vice President, Strategy and Corporate
Development, and Prof. St phane Depil, MD, PhD, to the role of Senior
Vice President Research & Development and Chief Medical Officer. Ms.
Boglioli's responsibilities include directing the long-term strategy and
current business priorities of Cellectis to ensure that the overall
mission of the Company is fulfilled. Ms. Boglioli joins Cellectis from
Boston Consulting Group (BCG), where she served as Partner and Managing
Director, and leader of BCG's biotech-focused business in Europe. Prof.
Depil's responsibilities include bringing Cellectis' product candidates
to clinical-stage development, strategic and operational management of
all therapeutic activities, and supervising research and development
projects for the Company. Prof. Depil continues his academic and
research activities as adjunct Professor at L on B rard Cancer Center &
University Claude Bernard in Lyon, France.
Scientific Publications
A poster has been presented at the Keystone Conference in February 2018,
showcasing the high gene-editing efficiency of TALEN . A T-cell was
edited using TALEN , to knock out the TCR alpha and beta chain, knock
out the B2M molecule, knock in the CAR construct and knock in an NK cell