Believed to be the first FDA IND clearance of
an allogeneic dual CAR-T therapy targeting CD19 and CD20
SAN DIEGO, July 5, 2023 /PRNewswire/ -- Poseida
Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene
therapy company advancing a new class of treatments for patients
with cancer and rare diseases, today announced that the U.S. Food
and Drug Administration (FDA) has cleared its Investigational New
Drug (IND) application for P-CD19CD20-ALLO1, the Company's first
allogeneic dual CAR-T cell product candidate, which targets both
CD19 and CD20 antigens for the treatment of relapsed or refractory
B-cell malignancies and is being developed in partnership with
Roche.
"We are pleased to receive IND clearance for P-CD19CD20-ALLO1,
our third fully allogeneic CAR-T cell product candidate and the
second therapy in our partnership with Roche for hematological
malignancies that will enter the clinic. We believe this represents
the FDA's first known IND clearance of an allogeneic dual CAR-T
therapy targeting CD19 and CD20," said Kristin Yarema, Ph.D., President, Cell Therapy
at Poseida. "The dual-targeting approach leverages our proprietary
non-viral piggyBac® DNA Delivery System, which enables
expression of two fully functional CAR molecules into T cells from
healthy donors for the treatment of B-cell malignancies that may
have heterogeneous antigen expression. We believe that targeting
both CD19 and CD20 has the potential to overcome the limitations of
currently available CD19-directed CAR-T products where antigen
escape has been observed as an important resistance mechanism.
It has been estimated that up to 40% of cases where B-cell
malignancies relapse or are refractory to CD19 targeting autologous
CAR-T therapy may involve antigen escape. We look forward to
dosing the first patients in this study."
P-CD19CD20-ALLO1 will be evaluated in a Phase 1 multi-center,
open-label, dose-escalation study that will enroll up to 70 adult
patients with relapsed or refractory B-cell malignancies. The study
will evaluate the safety, tolerability, and preliminary efficacy of
P-CD19CD20-ALLO1. After enrollment, patients will receive a
chemotherapy-based lymphodepletion regimen followed by
administration of P-CD19CD20-ALLO1 allogeneic CAR-T cells. With the
P-CD19CD20-ALLO1 IND now cleared, the Company is actively focused
on opening clinical sites.
About P-CD19CD20-ALLO1
P-CD19CD20-ALLO1 is an allogeneic CAR-T cell therapy product
candidate being developed for relapsed or refractory B-cell
malignancies in partnership with Roche. P-CD19CD20-ALLO1 expresses
two fully functional CAR molecules to target cells that express
either CD19 or CD20. The dual targeting approach employed in
P-CD19CD20-ALLO1 aims to overcome the antigen escape limitations of
CD19-only targeted CAR-T therapies by simultaneously targeting both
CD19 and CD20. In addition to the dual targeting,
P-CD19CD20-ALLO1 uses a novel CD19 binder that showed greater
potency in in vivo preclinical models when compared to the
canonical FMC63 Single-chain variable fragment (scFv) binder.
P-CD19CD20-ALLO1 is an off-the-shelf CAR-T therapy for which
patients do not have to undergo apheresis and wait for the cells to
be manufactured, which can potentially overcome the limitation of
autologous CAR-T therapies associated with significant
manufacturing times. P-CD19CD20-ALLO1 will be studied in multiple
B-cell malignancies.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical
company advancing differentiated cell and gene therapies with the
capacity to cure certain cancers and rare diseases. The Company's
pipeline includes allogeneic CAR-T cell therapy product candidates
for both solid and liquid tumors as well as in vivo gene therapy
product candidates that address patient populations with high unmet
medical need. The Company's approach to cell and gene therapies is
based on its proprietary genetic editing platforms, including its
non-viral piggyBac® DNA Delivery System,
Cas-CLOVER™ Site-Specific Gene Editing System and nanoparticle and
hybrid gene delivery technologies. The Company has formed a global
strategic collaboration with Roche to unlock the promise of cell
therapies for patients. Learn more at www.poseida.com and connect
with us on Twitter and LinkedIn.
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Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements include statements
regarding, among other things, expected plans with respect to
clinical trials, including timing of regulatory submissions and
approvals and clinical data updates; anticipated timelines and
milestones with respect to the Company's development programs and
manufacturing activities and capabilities; the potential
capabilities and benefits of the Company's technology platforms and
product candidates; and the Company's plans and strategy with
respect to developing its technologies and product candidates.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. These forward-looking
statements are based upon the Company's current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
the Company's reliance on third parties for various aspects of its
business; risks and uncertainties associated with development and
regulatory approval of novel product candidates in the
biopharmaceutical industry; the Company's ability to retain key
scientific or management personnel; the fact that the Company will
have limited control over the efforts and resources that Roche
devotes to advancing development programs under its collaboration
agreement and the Company may not receive the potential fees and
payments under the collaboration agreement and the ability of Roche
to early terminate the collaboration, such that the Company may not
fully realize the benefits of such collaboration; and the other
risks described in the Company's filings with the Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made. The Company undertakes no obligation to update such
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after the date on which they were made, except as required by
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SOURCE Poseida Therapeutics, Inc.
