Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR™ T Cell Therapy, for the Treatmen...
June 30 2021 - 8:30AM
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 the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation to ALLO-605, the Company’s next-generation AlloCAR T
therapy targeting BCMA for the treatment of relapsed or refractory
multiple myeloma. The FDA granted Fast Track designation based on
the potential of ALLO-605 to address the unmet need for patients
who have failed other standard multiple myeloma therapies. The
Phase 1 dose escalation portion of the IGNITE trial evaluating
ALLO-605 was initiated in Q2 2021.
ALLO-605 is the Company’s first TurboCAR™ clinical candidate.
TurboCAR is a proprietary, next generation platform technology
based upon programmable cytokine signaling designed to improve the
function and potency of AlloCAR T™ cells. These properties may also
enable CAR T therapy to succeed in solid tumors and increase
efficacy in hematologic malignancies. Preclinical results from the
ALLO-605 study were presented in a poster session at the American
Society of Hematology (ASH) annual meeting in December of 2020.
“We are very pleased with the continued momentum of our
anti-BCMA portfolio for patients with multiple myeloma and look
forward to making allogeneic CAR T therapy a potential option for
these patients,” said Rafael Amado, M.D., Executive Vice President
of Research and Development and Chief Medical Officer. “With
studies now underway for ALLO-715 alone and in combination with a
gamma secretase inhibitor, as well as ALLO-605 as our next
generation CAR T, we are taking an aggressive three-pronged
approach aimed at exploring the unique attributes of AlloCAR T
therapies for patients with rapidly progressing disease.” Initial
results from the Phase 1 UNIVERSAL study of ALLO-715 in
relapsed/refractory multiple myeloma were presented at an oral
session of the ASH annual meeting in December 2020. In April 2021,
ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT)
designation by the FDA. Separately, the UNIVERSAL study began
enrolling patients in the first half of 2021 to evaluate ALLO-715
in combination with SpringWorks Therapeutics’ investigational gamma
secretase inhibitor, nirogacestat.
Fast Track is designed to accelerate the development and review
of treatments for serious and life-threatening diseases where no
treatment exists or where the treatment in discovery may be better
than what is currently available.
About ALLO-605ALLO-605 is a next-generation
AlloCAR T investigational therapy that targets the B-cell
maturation antigen (BCMA) for the treatment of patients with
relapsed/refractory multiple myeloma and other BCMA-positive
malignancies. This study uses ALLO-647, Allogene's proprietary
monoclonal antibody (mAb), as a part of its differentiated
lymphodepletion regimen. ALLO-605 incorporates Allogene’s
proprietary TurboCAR technology, which allows for cytokine
activation signaling to be engineered selectively into CAR T cells.
Preclinical results with ALLO-605 were presented at the American
Society of Hematology (ASH) annual meeting in December 2020. In
June 2021, ALLO-605 was granted Fast Track designation by the U.S.
Food and Drug Administration (FDA) for the potential treatment of
relapsed/refractory multiple myeloma.
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
IGNITE trial of ALLO-605; the ability of ALLO-605 and other
TurboCAR™ candidates to improve the function and potency of AlloCAR
T™ cells, enable success in solid tumors and increase efficacy in
hematologic malignancies; 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 March 31, 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™ and TurboCAR™ are trademarks of Allogene
Therapeutics, Inc.
ALLO-605 and ALLO-715 utilize TALEN® gene-editing technology
pioneered and owned by Cellectis. Allogene has an exclusive license
to the Cellectis technology for allogeneic products directed at
BCMA and holds all global development and commercial rights for
this investigational candidate.
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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