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
preliminary results from Cellectis’ dose escalation Phase 1
BALLI-01 study of UCART22 product candidate in relapsed/refractory
B-cell Acute Lymphoblastic Leukemia (B-ALL) were presented at the
American Society of Hematology (ASH) Annual Meeting. This is the
first publicly released data from Cellectis’ BALLI-01 clinical
trial.
The BALLI-01 clinical trial presentation
released at the ASH Annual Meeting is available on the Cellectis
website: https://bit.ly/CellectisASH2020
“We are encouraged by the promising preliminary
data obtained from the first two lower dose levels of UCART22
following a standard fludarabine and cyclophosphamide
lymphodepletion regimen from the BALLI-01 trial. The anti-leukemia
activity observed in these patients with B-ALL who had been
previously heavily pre-treated speaks to the validity of CD22 as a
target in the CAR T-cell space, and demonstrates the promise of
allogeneic cellular therapies to leapfrog the autologous CAR-T
products. We have now started enrolling cohorts that include
alemtuzumab, an anti-CD52 monoclonal antibody, in the
lymphodepletion regimen, as we anticipate this may extend the
window of persistence of our TALEN® gene-edited
allogeneic CAR T-cells,” said Carrie Brownstein, MD, Chief Medical
Officer, Cellectis. “Based on the strong progress of our partnered-
and proprietary product candidate portfolio, which was presented at
ASH, we are looking forward to presenting additional clinical data
in 2021.”
Characteristics
As of the November 2, 2020 data cutoff, 7
patients were enrolled and 5 patients received UCART22 cells. One
patient failed screening and one patient was discontinued prior to
the administration of UCART22 cells due to an adverse event related
to the lymphodepletion.
Safety
No patient experienced a DLT, ICANS, GvHD,
AESI1, nor UCART22-related Grade ≥3 adverse event (AE) nor serious
adverse event (SAE). No patient discontinued treatment due to a
UCART22-related treatment-emergent adverse event.
Anti-leukemic Activity
Two patients in Dose Level 1 achieved an
objective response of complete remission with incomplete
hematologic recovery (CRi) at Day 28, one of which attained a
complete remission (CR) at Day 42 and received a transplant after
subsequent therapy with inotuzumab. One patient in Dose Level 2
with refractory disease did achieve a noteworthy reduction in bone
marrow blasts (60% at screening down to 13% at Day 28) after
treatment with UCART22 product candidate and then progressed.
Host lymphocyte reconstitution was observed in
all patients within the DLT period (range Day 9-Day 28).
Correlative analysis of UCART cell expansion and persistence is
ongoing.
UCART22 demonstrated preliminary signs of
activity at low dose levels with fludarabine/cyclophosphamide (FC)
lymphodepletion regimen, without unexpected nor significant
treatment-related toxicities. Host immune recovery was observed
early, supporting the addition of alemtuzumab to the FC
lymphodepletion regimen which is expected to result in a deeper and
more sustained T-cell depletion and thereby promote expansion and
persistence of UCART22 cells. Enrollment into the Dose Level 2
cohorts with alemtuzumab is ongoing.
Treatment-emergent adverse events of interest with DL1 and
DL2 |
|
Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Grade 5 |
Graft-versus-host disease (GvHD) |
0 |
0 |
0 |
0 |
0 |
Cytokine release syndrome (CRS) |
2 |
1 |
0 |
0 |
0 |
ICANS |
0 |
0 |
0 |
0 |
0 |
SAEs2 |
|
|
3 |
1 |
1 |
1 DLT: Dose Limiting Toxicity; GvHD: Graft versus Host Disease;
AESI: adverse event of special interest; ICANS: immune effector
cell-associated neurotoxicity syndrome; AE: Adverse Event; SAE:
Serious Adverse Event2 SAEs that are not related to UCART22
cells
About UCART22UCART22 is one of
Cellectis’ wholly owned, allogeneic, off-the-shelf gene-edited
T-cell product candidates, designed for the treatment of relapsed
and refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
Like CD19, CD22 is a cell surface antigen expressed from the
pre-B-cell stage of development through mature B-cells. CD22
expression occurs in more than 90% of patients with B-ALL.
About CellectisCellectis is
developing the first of its kind allogeneic approach for CAR-T
immunotherapies in oncology, pioneering the concept of
off-the-shelf and ready-to-use gene-edited CAR T-cells to treat
cancer patients. As a clinical-stage biopharmaceutical company with
over 20 years of expertise in gene editing, Cellectis is developing
life-changing product candidates utilizing TALEN®, its gene editing
technology, and PulseAgile, its pioneering electroporation system
to harness the power of the immune system in order to target and
eradicate cancer cells.
As part of its commitment to a cure, Cellectis
remains dedicated to its goal of providing life-saving UCART
product candidates to address unmet needs for multiple cancers
including acute myeloid leukemia (AML), B-cell acute lymphoblastic
leukemia (B-ALL) and multiple myeloma (MM).
Cellectis headquarters are in Paris, France,
with additional locations in New York, New York and Raleigh, North
Carolina. Cellectis is listed on the Nasdaq Global Market (ticker:
CLLS) and on Euronext Growth (ticker: ALCLS). For more information,
visit www.cellectis.com.
Follow Cellectis on social media: @cellectis,
LinkedIn and YouTube.
TALEN® is a registered trademark owned by
Cellectis.
For further information, please
contact:
Media contacts:Jennifer Moore,
SVP, Public Relations, 917-580-1088, media@cellectis.comCaitlin
Kasunich, KCSA Strategic Communications, 212-896-1241,
ckasunich@kcsa.com
IR contact:Simon Harnest, SVP,
Corporate Strategy and Finance, 646-385-9008,
simon.harnest@cellectis.com
Disclaimer
This press release contains “forward-looking”
statements within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by words such as “at
this time,” “believe,” “expected,” “forward looking”, “promising”
and “will”, or the negative of these and similar expressions. These
forward-looking statements, which are based on our management’s
current expectations and assumptions and on information currently
available to management, include statements about the timing and
progress of clinical trials (including with respect to patient
enrollment and follow-up), the ability of an anti-CD52 to improve
any efficacy, the timing of our presentation of data, the adequacy
of our supply of clinical vials, and the sufficiency of cash to
fund operations. These forward-looking statements are made in light
of information currently available to us and are subject to
numerous risks and uncertainties, including with respect to the
duration and severity of the COVID-19 pandemic and governmental and
regulatory measures implemented in response to the evolving
situation. Furthermore, many other important factors, including
those described in our Annual Report on Form 20-F and the financial
report (including the management report) for the year ended
December 31, 2019 and subsequent filings Cellectis makes with the
Securities Exchange Commission from time to time, as well as other
known and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results,
performance or achievements to be materially different from those
expressed or implied by the forward-looking statements. 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.
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