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 initial data from its Phase 1 UNIVERSAL trial of ALLO-715,
an anti-BCMA AlloCAR T therapy, in relapsed/refractory multiple
myeloma in an oral presentation at the 62nd Annual Meeting of the
American Society of Hematology (ASH), taking place virtually
December 5 – 8, 2020. Preclinical findings from investigations of
ALLO-316, an AlloCAR T targeting CD70 in acute myeloid leukemia and
ALLO-605, a BCMA-directed TurboCAR TTM cell therapy in multiple
myeloma, will also be presented in poster sessions.
“We’re looking forward to presenting initial clinical data for
our first anti-BCMA AlloCAR T therapy, ALLO-715, which we believe
will provide insights into how we might optimize lymphodepletion
and cell dose to reach its potential for patients in need of
readily available treatments options,” said Rafael Amado, M.D.,
Executive Vice President of Research & Development and Chief
Medical Officer of Allogene. “These findings will help inform trial
design for our BCMA platform as we look to advance ALLO-715, alone
and in combination with a gamma secretase inhibitor, as well as
ALLO-605, our first TurboCAR T clinical candidate.”
In the initial dose escalation phase of the UNIVERSAL trial,
patients received lymphodepletion (LD) followed by ALLO-715 at one
of three dose levels (DL) in a 3+3 dose escalation design. At the
time of the July 2020 abstract data cutoff, two LD regimens were
being evaluated:
- FCA: Fludarabine 90 mg/m2,
Cyclophosphamide 900 mg/m2, and
ALLO-647 39 mg divided over three days; and
- CA: Cyclophosphamide 900 mg/m2 and
ALLO-647 39 mg divided over three days.
The ASH abstract includes preliminary data on the first 15
patients evaluable for efficacy and treated with escalating doses
of ALLO-715 as well as lower dose (39mg) ALLO-647. Patients were in
advanced stage of disease with a median of five prior lines of
therapy. The trial did not permit bridging therapy. In 15 evaluable
patients, higher dose of ALLO-715 (DL3) achieved greater activity
with 60% (3/5) patients responding (95% CI 14.7, 94.7). Of the
three patients who received DL3 FCA, two responded (1 stringent
complete response (sCR) and 1 very good partial response (VGPR))
and both were minimum residual disease (MRD) negative by local MRD
testing.
LD Regimen and Cell Dose |
FCA |
CA |
Overall DL3(95%
CI)(N=5) |
DL140 x 106CAR+ cells(N=3) |
DL2160 x 106CAR+ cells(N=4) |
DL3320 x 106CAR+ cells(N=3) |
DL2160 x 106CAR+ cells(N=3) |
DL3320 x 106CAR+ cells(N=2) |
ORR, n (%) |
0 (0%) |
2 (50%) |
2 (66%) |
0 (0%) |
1(50%) |
3/5
(60%)(14.7,
94.7) |
At the time of the data cutoff, 17 of the patients were
evaluable for safety. No neurotoxicity or graft-vs-host disease
(GvHD) was observed. Cytokine release syndrome (CRS) was reported
in four patients (24%) with three Grade 1 and one Grade 2. All CRS
was resolved without tocilizumab or corticosteroids. The most
common Grade ≥ 3 adverse events were anemia (41.2%), neutropenia
(41.2%), lymphopenia (29.4%), and thrombocytopenia (29.4%).
Four (23.5%) instances of Grade ≥ 3 infections were observed.
Three of these were Grade 3 and resolved with treatment. The fourth
was a Grade 5 event of suspected fungal pneumonia that occurred on
day eight post-ALLO-715 infusion. The suspected fungal pneumonia
was diagnosed on the day after cell infusion in this patient with
advanced and rapidly progressing disease who had failed multiple
lines of therapy. This event occurred in the CA cohort, and it was
assessed by the investigator as related to progressive disease and
the CA conditioning.
The oral presentation will include data on approximately 20
patients evaluable for efficacy across ALLO-715 cell dose cohorts
and lower dose (39mg) of ALLO-647, as well as patients evaluable
for efficacy who were treated with a higher dose of ALLO-715 and
higher doses of ALLO-647. The Phase 1 UNIVERSAL study continues to
enroll patients at these higher doses in an effort to optimize the
therapy.
The ASH abstracts are now available at www.hematology.org.
Allogene will also host a conference call on December 5th following
the virtual presentation. Details on the ASH presentations are as
follows:
Allogene Oral Presentation
Session: 653. Myeloma/Amyloidosis: Therapy,
Excluding Transplantation; CAR T Therapies for Myeloma: Novel
Approaches and Longer-Term Follow Up Data Abstract
#129Title: Universal: An Allogeneic First-in-Human
Study of the Anti-BCMA ALLO-715 and the Anti-CD52 ALLO-647 in
Relapsed/Refractory Multiple Myeloma Presenter:
Sham Mailankody, M.D., Memorial Sloan Kettering Cancer
CenterSession Date & Time: Saturday, December
5, 2020; 9:30 a.m. - 11 a.m. PT
Allogene Poster Presentations
Session: 616. Acute Myeloid Leukemia: Novel
Therapy, Excluding Transplantation: Poster
IIAbstract #1972Title:
Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T
Targeting CD70 As a Potential Therapy for the Treatment of AML
Presenter: Nguyen Tan, Allogene Therapeutics
Session Date & Time: Sunday, December 6, 2020;
7 a.m. - 3:30 p.m. PT
Session: 703. Adoptive Immunotherapy:
Mechanisms and New Approaches: Poster IIIAbstract
#3258Title: Preclinical Evaluation of ALLO-605, an
Allogeneic BCMA TurboCAR TTM Cell Therapy for the Treatment of
Multiple MyelomaPresenter: Cesar Sommer, Ph.D.,
Allogene TherapeuticsSession Date & Time:
Monday, December 7, 2020; 7 a.m. - 3 p.m. PT
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
StatementsThis 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 Phase 1
trial of ALLO-715; current data and clinical outcomes, which may
materially change as patient enrollment continues and more patient
data become available; the ability to initiate and progress a
clinical trial of ALLO-715 with a gamma secretase inhibitor; the
ability to initiate and progress a clinical trial of ALLO-605; the
ability to manufacture AlloCAR T™ therapies; and the potential
benefits of AlloCAR T therapies. 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
September 30, 2020. 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.
ALLO-715 (BCMA), ALLO-605 (BCMA) and ALLO-316 (CD70) utilize
TALEN® gene-editing technology pioneered and owned by Cellectis.
Allogene has an exclusive license to the Cellectis technology for
allogeneic products directed at these targets 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
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