Allogene Therapeutics Receives FDA Orphan Drug Designation (ODD) for ALLO-715 for the Treatment of Multiple Myeloma (MM)
August 12 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 orphan-drug
designation (ODD) to ALLO-715 for the treatment of multiple
myeloma.
Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in
relapsed/refractory multiple myeloma were presented at an oral
session of the American Society of Hematology annual meeting in
December 2020. In April 2021, ALLO-715 was granted Regenerative
Medicine Advanced Therapy (RMAT) designation by the U.S. Food and
Drug Administration (FDA). The UNIVERSAL trial continues to enroll
patients to ALLO-715 including in combination with nirogacestat, a
gamma secretase inhibitor from SpringWorks Therapeutics and in
consolidation therapy.
“We are pleased to have received ODD for ALLO-715 just months
after the FDA granted RMAT designation. These designations from the
FDA underscore the importance of bringing this important
therapeutic option to patients with multiple myeloma,” said Rafael
Amado, M.D., Executive Vice President of Research & Development
and Chief Medical Officer of Allogene. “We look forward to
presenting the next update from our UNIVERSAL trial by the end of
2021 and providing additional insight into the potential of our
allogeneic cell therapy platform.”
Orphan-drug designation is granted by the FDA to a drug or
biologic intended to treat a rare disease or condition, which
generally includes a disease or condition that affects fewer than
200,000 individuals in the U.S. ODD granted therapies entitle
companies to development incentives including tax credits for
clinical testing, prescription drug user fee exemptions, and seven
year marketing exclusivity in the event of regulatory approval. ODD
does not convey any advantage in, or shorten the duration of, the
regulatory review or approval process.
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 originates in the bone marrow, and
it is characterized by abnormalities in plasma cells that reproduce
uncontrollably in the bone marrow and other disease sites. Multiple
myeloma is incurable for most patients, as relapses occur despite
most treatments available. Initial results from the Phase 1
UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma
were presented in December 2020 at an oral session of the American
Society of Hematology (ASH) annual meeting. In April 2021, ALLO-715
was granted Regenerative Medicine Advanced Therapy (RMAT)
designation by the U.S. Food and Drug Administration (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
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 timing and ability to progress
the UNIVERSAL trial and present any data from the trial; clinical
outcomes, which may materially change as patient enrollment
continues and more patient data become available; 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.
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 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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