Full Press Release Details
Reports Financial Results for 3rd
Quarter and First Nine Months 2018
in Phase 1 clinical trial for AML and BPDCN patients;
Phase 1 study protocol approved by FDA for B-ALL patients;
ASH abstract by partner Servier shows continued progress of first
clinical allogeneic CAR T-cell program for ALL patients;
clinical trial expected to start in 2019 for Multiple Myeloma patients;
position of $476M as of September 30, 2018 compared to $297M as of
NEW YORK--(BUSINESS WIRE)--November 13, 2018--Regulatory News:
Cellectis S.A. (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), today announced its results for the three-month period ended
September 30, 2018 and for the nine-month period end September 30, 2018.
1 Cash position includes cash, cash equivalent and current
Third Quarter 2018 and Recent Highlights
UCART123 (wholly controlled) - AML & BPDCN patients
The Phases 1 dose escalation studies of UCART123 in acute myeloid
leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)
patients at MD Anderson Cancer Center and Weill Cornell Medical Center
For the AML clinical trial, the current dose level of 2.5x105
UCART123 cells per kilogram will be followed by dose levels 2 and 3 with
6.25x105 and 5.05x106 UCART123 cells per kilogram.
We are expecting to dose 2-4 patients per dose cohort, with a treatment
follow-up period of 4 weeks per patient as well as an option to re-dose
responding patients.
UCART22 (wholly controlled) - B-ALL patients
The FDA approved an IND for UCART22, with a first Phase 1 clinical study
in B-cell acute lymphoblastic leukemia (B-ALL) adult patients.
UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell
product candidate developed by Cellectis to enter clinical trials.
UCART22 is designed for the treatment of CD22-expressing cancer 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). The clinical research for UCART22 will be led
by Dr. Nitin Jain, Assistant Professor at The University of Texas MD
Anderson Cancer Center in Houston, and Prof. Hagop Kantarjian, Professor
and Chair in the Department of Leukemia and University Chair in Cancer
Medicine, at The University of Texas MD Anderson Cancer Center in
UCARTCS1 (wholly controlled) - Multiple Myeloma patients
A clinical trial for UCARTCS1 is expected to start in 2019 in Multiple
UCARTCS1 is our first allogeneic CAR T-cell product candidate for the
treatment of Multiple Myeloma (MM) patients. We have chosen CS1 (also
known as SLAMF7) as the targeted antigen for this program, based on the
high levels of expression of CS1 in MM patients on malignant cells
relative to the low level of expression on non-malignant cells as well
as on the results of third parties' proof of concept for this high value
target achieved with the elotuzumab monoclonal antibody in MM patients.
UCART19 (partnered, exclusively licensed to Servier) - ALL patients
Recently, an abstract titled "896 Preliminary Data on Safety, Cellular
Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19
CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with
High-Risk CD19+ Relapsed/Refractory B-Cell Acute
Lymphoblastic Leukemia" for oral presentation at the 60th American
Society of Hematology (ASH) Annual Meeting, was published online,
showing the continued progress of UCART19 in Phase 1 clinical trials,
for both pediatric and adult ALL patients.
After UCART19 infusion, 88% of evaluable patients (14/16) achieved a
complete remission (CR) or complete remission with incomplete blood cell
recovery (CRi) by day 28 or day 42 post UCART19 infusion and 86% (12/14)
of these patients were measurable residual disease' (MRD) negative (MRD-
stands for less than 1 leukemic cell among 104 normal cells)
assessed by flow or qPCR.
We are pleased to see continued progress for UCART19 under the
management of our partner Servier.
Under the collaboration agreement with Servier from 2014, Cellectis is
entitled to receive up to $350 million in clinical and regulatory
milestone payments, as well as tiered royalties in the high single
digits on worldwide sales.
ALLO-715 (BCMA) and ALLO-819 (Flt3) (partnered, exclusively licensed
In addition, Allogene has released (i) an abstract for oral presentation
at ASH 2018 annual meeting, describing pre-clinical research on
ALLO-715, an allogeneic BCMA CAR T therapy possessing an off-switch for
the treatment of Multiple Myeloma, and (ii) an abstract for a poster
presentation for ALLO-819, an allogeneic Flt3 CAR T therapy possessing
an off-switch for the treatment of acute myeloid leukemia (AML).
ALLO-715 and ALLO-819 were progressed under a joint research
collaboration with Allogene, and are directed to targets that were
licensed exclusively from Cellectis. Allogene holds the exclusive global
development and commercial rights for these product candidates.
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 worldwide
sales of any products that are developed by Allogene, as originally
agreed to under the June 17, 2014 Collaboration Agreement with Pfizer.
We are currently in the process of internalizing large parts of our
proprietary manufacturing chain for clinical supplies and we are
planning to build a proprietary cGMP, commercial scale manufacturing
facility in the United States.
Corporate Governance
On August 2, 2018, Cellectis announced the appointment of Dr. Stefan
Scherer, M.D., Ph.D., to the role of Senior Vice President Clinical
Development and Deputy Chief Medical Officer.
On September 19, 2018, Cellectis announced that Stephan A. Grupp, MD,
Ph.D., a leading pediatric oncologist at Children's Hospital of
Philadelphia and Chief of the Section of Cellular Therapy and Transplant
at the Children's Hospital of Philadelphia (CHOP) joined the Company's
Clinical Advisory Board (CAB).
Cellectis' consolidated financial statements have been prepared in