Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic
chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer
and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage
biopharmaceutical company focused on developing life-changing
medicines for patients with severe rare diseases and cancer, today
announced that they have entered into a clinical trial
collaboration agreement. This agreement will evaluate ALLO-715,
Allogene’s investigational anti-B-cell maturation antigen (BCMA)
AlloCAR T therapy in combination with SpringWorks’ investigational
gamma secretase inhibitor (GSI), nirogacestat, in patients with
relapsed or refractory multiple myeloma.
Gamma secretase inhibition prevents the cleavage and shedding of
BCMA from the surface of myeloma cells. In preclinical models,
nirogacestat has been shown to increase the cell surface density of
BCMA and reduce levels of soluble BCMA, thereby enhancing the
activity of BCMA-targeted therapies.1 In addition, emerging
clinical data suggest that a GSI may increase antitumor efficacy of
BCMA-targeted autologous CAR T therapy in patients with relapsed
and refractory multiple myeloma.2 3
“Autologous CAR T therapy has shown the potential for engineered
cell therapy to treat multiple myeloma and provide significant
benefits to patients. We believe allogeneic CAR T therapy is the
next frontier in genetically engineered cell therapy for the
treatment of cancer,” said David Chang, M.D., Ph.D., President, CEO
and Co-Founder of Allogene Therapeutics. “The search to find
long-lasting and potentially curative therapies for patients with
multiple myeloma continues to evolve. We are pleased with the
progress of our ALLO-715 Phase 1 UNIVERSAL trial and are excited to
explore the combination of ALLO-715 with nirogacestat as a means to
further unlock the potential of allogeneic CAR T therapy in this
disease.”
Under the terms of the agreement, Allogene will sponsor and
conduct the Phase 1 study to evaluate the safety, tolerability and
preliminary efficacy of the combination, and will assume all
development costs associated with the study. Allogene and
SpringWorks will form a joint development committee to oversee the
clinical study, which is expected to commence in the second half of
2020 pending discussions with regulators.
“Gamma secretase inhibition has emerged as a clinically
validated mechanism to potentiate BCMA therapies and we believe
that nirogacestat has the potential to become a cornerstone of BCMA
combination therapy for patients with multiple myeloma,” said Saqib
Islam, Chief Executive Officer of SpringWorks Therapeutics. “We are
delighted to partner with Allogene, a pioneer in the allogenic cell
therapy field, to further explore nirogacestat in combination with
an ‘off-the-shelf’ CAR T therapy for these patients where the need
for treatment options remains great.”
SpringWorks is currently enrolling patients in a global Phase 3,
double-blind, randomized, placebo-controlled clinical trial (the
DeFi Trial) to evaluate nirogacestat in adults with progressing
desmoid tumors.
About ALLO-715ALLO-715, an AlloCAR T therapy
targeting B-cell maturation antigen (BCMA), is currently in Phase 1
development as a potential novel treatment for multiple myeloma.
Multiple myeloma is characterized by abnormalities in plasma cells
that reproduce uncontrollably in the bone marrow of people with the
disease,4 multiple myeloma is incurable for most patients, and
most patients relapse despite the treatments
available.5 Preclinical study results for ALLO-715 were
published in the journal Molecular Therapy validating the potential
for an AlloCAR T to treat multiple myeloma and demonstrating the
ability for ALLO-715 to sustain potent anti-tumor responses in
pre-clinical models. Allogene initiated the UNIVERSAL study in the
third quarter of 2019.
ALLO-715 utilizes TALEN® gene-editing technology pioneered and
owned by Cellectis. Allogene has an exclusive license to the
Cellectis technology for allogeneic products directed at the BCMA
target. Allogene holds global development and commercial rights for
this investigational candidate.
About NirogacestatNirogacestat is an
investigational, oral, selective, small molecule gamma-secretase
inhibitor in Phase 3 clinical development for desmoid tumors, which
are rare and often debilitating and disfiguring soft-tissue tumors.
Gamma secretase cleaves multiple transmembrane protein complexes,
including Notch, which is believed to play a role in activating
pathways that contribute to desmoid tumor growth.
In addition, gamma secretase has been shown to directly cleave
membrane-bound BCMA, resulting in the release of the BCMA
extracellular domain, or ECD, from the cell surface. By inhibiting
gamma secretase, membrane-bound BCMA can be preserved, increasing
target density while reducing levels of soluble BCMA ECD, which may
serve as decoy receptors for BCMA-directed therapies.
Nirogacestat’s ability to enhance the activity of BCMA-directed
therapies has been observed in preclinical models of multiple
myeloma. SpringWorks is pursuing a combination therapy approach to
evaluate nirogacestat as a BCMA potentiator across modalities by
collaborating with industry leaders. To date, SpringWorks has
entered into two clinical collaborations to evaluate nirogacestat
in combination with GlaxoSmithKline’s BCMA antibody-drug conjugate
belantamab mafodotin and with Allogene’s allogeneic BCMA CAR-T cell
therapy ALLO-715.
Nirogacestat has received Orphan Drug Designation from the U.S.
Food and Drug Administration (FDA) for the treatment of desmoid
tumors (June 2018) and from the European Commission for the
treatment of soft tissue sarcoma (September 2019). The FDA also
granted Fast Track and Breakthrough Therapy Designations for the
treatment of adult patients with progressive, unresectable,
recurrent or refractory desmoid tumors or deep fibromatosis
(November 2018 and August 2019).
About Allogene Therapeutics Allogene
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 world-class 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.
About SpringWorks TherapeuticsSpringWorks is a
clinical-stage biopharmaceutical company applying a precision
medicine approach to acquiring, developing and commercializing
life-changing medicines for underserved patient populations
suffering from devastating rare diseases and cancer. SpringWorks
has a differentiated portfolio of small molecule targeted oncology
product candidates and is advancing two potentially registrational
clinical trials in rare tumor types, as well as several other
programs addressing highly prevalent, genetically defined cancers.
SpringWorks’ strategic approach and operational excellence in
clinical development have enabled it to rapidly advance its two
lead product candidates into late-stage clinical trials while
simultaneously entering into multiple shared-value partnerships
with industry leaders to expand its portfolio. For more
information, please visit www.springworkstx.com. Follow SpringWorks
Therapeutics on social media: @SpringWorksTx and LinkedIn.
Allogene 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 timing and ability to initiate and advance a combination trial
for nirogacestat and ALLO-715, the potential benefits of the
combination trial, including the ability of nirogacestat to
increase BCMA surface expression to enable a deep and durable
response of ALLO-715, the ability to develop allogeneic CAR T
therapies for cancer 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 Securities and Exchange Commission
(SEC), including without limitation in its Form 10-Q for the
quarter ended September 30, 2019. 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.
SpringWorks Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements regarding
SpringWorks’ clinical trials and its strategy, business plans and
focus. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, statements regarding the future research and
development activities under the agreement with Allogene, the
timing for completion of SpringWorks’ clinical trials of its
product candidates, whether and when, if at all, SpringWorks’
product candidates will receive approval from the U.S. Food and
Drug Administration, or FDA, or other foreign regulatory
authorities, competition from other biopharmaceutical companies,
and other risks identified in the section entitled “Risk Factors”
in Item 1A of Part II of SpringWorks’ Quarterly Report on Form 10-Q
for the quarter ended September 30, 2019, as well as discussions of
potential risks, uncertainties and other important factors in
SpringWorks’ subsequent filings with the Securities and Exchange
Commission. SpringWorks cautions you not to place undue reliance on
any forward-looking statements, which speak only as of the date
they are made. SpringWorks disclaims any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent SpringWorks’ views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
SpringWorks Media/Investor Contact:Kim
DiamondVice President, Communications and Investor Relations(646)
661-1255kdiamond@springworkstx.com
_________________________
1 Eastman et al., Abstract #4401 “Synergistic Activity of
Belantamab Mafodotin (anti-BCMA immuno-conjugate) with Nirogacestat
(PF-03084014, gamma-secretase inhibitor) in BCMA-Expressing Cancer
Cell Lines”, ASH 2019.
2 Cowan et al., Abstract #204 “Efficacy and Safety of Fully
Human BCMA CAR T Cells in Combination with a Gamma Secretase
Inhibitor to Increase Bcma Surface Expression in Patients with
Relapsed or Refractory Multiple Myeloma”, ASH 2019.
3 Blood. 2019 Nov 7;134(19):1585-1597. doi:
10.1182/blood.2019000050
4 Multiple myeloma - Genetics Home Reference - NIH. Retrieved
from https://ghr.nlm.nih.gov/condition/multiple-myeloma#
5 Sonneveld P, Broijl A. Treatment of relapsed and refractory
multiple myeloma. Haematologica. 2016;101(4):396-406
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