Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer today announced that it will
present updated data from its blood cancer portfolio at the 63rd
Annual Meeting of the American Society of Hematology (ASH) taking
place December 11 – 14, 2021. Allogene will have two oral
presentations, one focused on the Phase 1 ALPHA2 study of ALLO-501A
in large B-cell lymphoma (LBCL) and one on the Phase 1 UNIVERSAL
single dose cohorts of ALLO-715 in relapsed/refractory multiple
myeloma (MM). The Company will also present data on the Phase 1
ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin’s
lymphoma (NHL) during a poster session. Updated data will be
included in the oral and poster sessions on December 13, 2021.
“We are looking forward to sharing additional data from our lead
AlloCAR T programs at the ASH Annual Meeting,” said Rafael Amado,
M.D., Executive Vice President of Research & Development and
Chief Medical Officer of Allogene. “We believe that our allogenic
CAR T therapies have the potential to enable a new and more hopeful
future for blood cancer patients who are in need of alternative
treatment options. The findings within our ASH abstracts continue
to support the promise and differentiation of our platform as we
look ahead to future development.”
Phase 1 ALPHA2 Trial (ALLO-501A)
AbstractALLO-501A is a next generation anti-CD19 AlloCAR T
engineered without the rituximab recognition domains in ALLO-501.
The Phase 1 dose escalation portion of the ALPHA2 trial in
relapsed/refractory LBCL was designed to confirm that the profile
of ALLO-501A is similar to ALLO-501 prior to advancing ALLO-501A
into a pivotal Phase 2 trial.
As of the ASH abstract data cutoff date of July 9, 2021, 12
patients (six each in single dose and consolidation dose cohorts)
were treated with follow-up for response at dose levels from 40 to
120 X 106 CAR+ cells of ALLO-501A. Consolidation dosing appeared to
be well tolerated with the potential for enhanced efficacy compared
to a single dose of ALLO-501A. In the consolidation cohort, both
the overall response rate (ORR) and complete response (CR) rate
were 67% with all three partial responses (PRs) converting to CR
following consolidation. All four consolidation patients who
achieved a CR remained in CR as of the data cut-off.
The safety profile was manageable in both single dose and
consolidation cohorts. Events of interest in the single dose cohort
were previously reported at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting. In the consolidation cohort, there
was no cytokine release syndrome (CRS), no graft-versus-host
disease (GvHD), no immune effector cell-associated neurotoxicity
syndrome (ICANS), no dose-limiting toxicities (DLTs), no dose
reductions, no Grade 3+ infections and infusion-related reactions
were Grade 2. Among all treated patients, cytopenias were the most
common adverse event and occurred in 72% of patients.
ALPHA2 (ALLO-501A) Oral Presentation (Abstract
#649)Session: 704. Cellular Immunotherapies: Allogeneic
CARs and CARs for T Cell Lymphomas Title: ALPHA2 Study:
ALLO-501A Allogeneic CAR T in LBCL, Updated Results Continue to
Show Encouraging Safety and Efficacy with Consolidation
DosingPresenter: Lazaros J. Lekakis, MD, University of Miami Health
SystemPresentation Date & Time: Monday, December 13, 2021;
10:30 AM ET
Phase 1 ALPHA Trial (ALLO-501) AbstractALLO-501
is a first generation anti-CD19 AlloCAR T product for the treatment
of relapsed/refractory NHL. Updated data from ALPHA highlight that
allogeneic CAR T therapy can be effectively and conveniently
delivered to enrolled patients with relapsed/refractory NHL with
responses observed across all cell doses and tumor histologies
(DLBCL and follicular lymphoma (FL)). In CAR T naïve patients
(n=36), response rates continued to be similar to those seen in
autologous CAR T therapy trials and the modified-intent-to-treat
(mITT) population remained nearly identical to the intent-to-treat
(ITT) population.
As of the July 9, 2021 ASH abstract data cutoff, five additional
patients were treated relative to the data previously reported at
the 2021 ASCO Annual Meeting. ORR and CR rates remain at 75% and
50%, respectively. In patients with LBCL (n=13), the ORR was 62%
and the CR rate was 46%. In patients with FL (n=23), the ORR was
83% and the CR rate was 52%. Four of the seven patients (all FL)
enrolled in the consolidation cohort were evaluable for assessment
after consolidation dosing at the time of the data cutoff with an
ORR and CR rate of 100% and 75%, respectively.
The percent of patients remaining in CR at six months following
a single infusion was 36% in LBCL, which is similar to 6-month CR
rates reported in the pivotal trials of autologous CAR T therapies,
with the longest ongoing CR at 15+ months, as of the data cut-off.
The 6-month CR rate in FL was 28%.
No cases of GvHD or DLTs were observed. As noted previously, one
case of Grade 3 ICANS was reported. Grade 1/2 CRS occurred in 22%
of patients with one case of Grade 3 CRS. All were managed with
standard protocols. Cytopenias were the most common adverse event
and occurred in 83% of patients. Infection rates remained similar
to those observed in autologous CAR T trials. There were no new
treatment-emergent deaths reported in this trial.
ALPHA (ALLO-501) Poster Presentation (Abstract
#3878)Session: 704. Cellular Immunotherapies: Clinical:
Poster III Title: ALPHA Study: ALLO-501 Produced Deep and
Durable Responses in Patients with Relapsed/Refractory
Non-Hodgkin’s Lymphoma Comparable to Autologous CAR TPresenter:
Sattva S. Neelapu, MD, The University of Texas, MD Anderson Cancer
CenterSession Date & Time: Monday, December 13, 2021; 6:00 PM -
8:00 PM ET
Phase 1 UNIVERSAL Trial (ALLO-715)
AbstractALLO-715 is an allogenic CAR T-cell therapy that
targets B-cell maturation antigen (BCMA). UNIVERSAL is a Phase 1
trial in adults with relapsed/refractory MM who have received
greater than three prior lines of therapy. Data from the UNIVERSAL
trial featured at ASH represents one of several strategies that the
Company is pursuing that targets BCMA in MM.
Findings from the UNIVERSAL trial indicate an allogeneic CAR T
therapy can be delivered rapidly without the need for bridging
therapy to patients with refractory multiple myeloma, with single
dose of therapy capable of inducing deep responses. The ASH
abstract contains data as of June 21, 2021. As of the data cut-off,
47 patients were enrolled and 42 patients were treated with
escalating doses of ALLO-715 and doses of ALLO-647 ranging from
39mg to 90mg. The median time from enrollment to lymphodepletion
was five days. Patients were in advanced stage of disease with a
median of five prior lines of therapy and 43% of patients being
penta refractory. The trial did not permit bridging therapy.
The efficacy analysis at the time of the abstract is focused on
the 26 patients treated at the highest two dose levels ((320 and
480 x 106 CAR+ cells) with fludarabine, cyclophosphamide and
ALLO-647 lymphodepletion. The ORR was 62% with a very good partial
response or better (VGPR+) rate of 39%. Median follow-up for these
patients was 7.4 months with a median duration of response of 8.3
months. Of the 10 patients with a best response of VGPR+, eight
were found to be minimal residual disease (MRD) negative.
No GvHD was observed. The most common Grade 3+ adverse events
included anemia, neutropenia, lymphopenia, and thrombocytopenia.
CRS was reported in 52% of patients, in all cases Grade 1/2 except
for one patient with Grade 3. One patient with Grade 2 CRS
experienced Grade 1 neurotoxicity that resolved. Grade 3+
infections occurred in 13% of patients, including two previously
reported Grade 5 events (fungal pneumonia and adenovirus
hepatitis).
UNIVERSAL (ALLO-715) Oral Presentation (Abstract
#651)Session: 704. Cellular Immunotherapies: Allogeneic
CARs and CARs for T Cell LymphomasTitle: Universal Updated Phase 1
Data Validates the Feasibility of Allogeneic Anti-BCMA ALLO-715
Therapy for Relapsed/Refractory Multiple MyelomaPresenter: Sham
Mailankody, MBBS, Memorial Sloan Kettering Cancer
CenterPresentation Date & Time: Monday, December 13, 2021;
11:00 AM ET
The ASH abstracts are now available at www.hematology.org.
About ALLO-501/ALLO-501A (Allogene
Sponsored)ALLO-501 and ALLO-501A are an anti-CD19
allogeneic CAR T (AlloCAR T™) products in development for the
treatment for relapsed or refractory non-Hodgkin lymphoma (NHL).
ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for
Phase 2 development, eliminates the rituximab recognition domains
in ALLO-501, which could allow for use in a broader patient
population, including NHL patients with recent rituximab exposure.
These trials are currently on clinical hold by the FDA.
About ALLO-715ALLO-715, an AlloCAR T therapy
targeting B-cell maturation antigen (BCMA), is a potential novel
treatment for multiple myeloma and other BCMA-positive
malignancies. Multiple myeloma is incurable for most patients, as
relapses occur despite most treatments available. ALLO-715 was
granted Regenerative Medicine Advanced Therapy (RMAT) designation
in April 2021 and orphan-drug designation (ODD) in August 2021 by
the U.S. Food and Drug Administration (FDA). This trial is
currently on clinical hold by the FDA.About Allogene
TherapeuticsAllogene Therapeutics, with headquarters
in South San Francisco, is a clinical-stage biotechnology
company pioneering the development of allogeneic chimeric antigen
receptor T cell (AlloCAR T™) therapies for cancer. Led by a
management team with significant experience in cell therapy,
Allogene is developing a pipeline of “off-the-shelf” CAR T cell
therapy candidates with the goal of delivering readily available
cell therapy on-demand, more reliably, and at greater scale to more
patients. For more information, please visit www.allogene.com,
and follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The press release may, in some cases, use terms
such as "predicts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans,"
"intends," "may," "could," "might," "will," "should" or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Forward-looking statements
include statements regarding intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the ability to progress the ALPHA, ALPHA2 and UNIVERSAL
trials and present any data from the trial; clinical outcomes,
which may materially change as more patient data become available;
the ability to resolve the current clinical hold on the Company’s
trials; and the potential benefits of AlloCAR T™ therapy. Various
factors may cause differences between Allogene’s expectations and
actual results as discussed in greater detail in Allogene’s filings
with the SEC, including without limitation in its Form 10-Q
for the quarter ended June 30, 2021. Any forward-looking
statements that are made in this press release speak only as of the
date of this press release. Allogene assumes no obligation to
update the forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
AlloCAR T™ is a trademark of Allogene Therapeutics,
Inc.
Allogene’s AlloCAR T™ programs utilize Cellectis technologies.
ALLO-501 and ALLO-501A are anti-CD19 products being jointly
developed under a collaboration agreement
between Servier1 and Allogene based on an exclusive
license granted by Cellectis
to Servier. Servier grants to Allogene exclusive
rights to ALLO-501 and ALLO-501A in
the U.S. while Servier retains exclusive rights
for all other countries. ALLO-715 targets BCMA. Allogene has an
exclusive license to the Cellectis technology for allogeneic
products directed at BCMA and holds all global development and
commercial rights for these investigational candidates.
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
1 Servier is an independent international
pharmaceutical company governed by a non-profit foundation, with
its headquarters in France (Suresnes).
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