SAN DIEGO, Dec. 20, 2021 /PRNewswire/ -- Poseida
Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage
biopharmaceutical company utilizing proprietary genetic engineering
platform technologies to create cell and gene therapeutics with the
capacity to cure, today announced that the U.S. Food and Drug
Administration (FDA) has cleared its Investigational New Drug (IND)
application for P-MUC1C-ALLO1, the Company's allogeneic CAR-T
product candidate targeting multiple solid tumor
indications.
Poseida announces FDA clearance of IND for P-MUC1C-ALLO1, a fully
#allogeneic CAR-T targeting multiple solid tumors.
"We are excited to begin the P-MUC1C-ALLO1 trial, an evaluation
of a fully allogeneic CAR-T product candidate with the potential to
treat a wide range of solid tumors, including breast, ovarian and
other cancers," said Eric Ostertag,
M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "The
genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully
eliminate alloreactivity, and our proprietary manufacturing
process, which includes our booster molecule, has the potential to
treat many patients from a single manufacturing run. We look
forward to beginning this trial and to presenting initial clinical
data in 2022."
P-MUC1C-ALLO1 is the Company's second fully allogeneic CAR-T
product candidate to receive IND clearance in 2021 following
P-BCMA-ALLO1 for the treatment of relapsed/refractory multiple
myeloma. P-MUC1C-ALLO1 is the first product candidate to be
produced out of the Company's new GMP facility, an internal pilot
manufacturing plant located at its San
Diego headquarters.
P-MUC1C-ALLO1 will be evaluated in a Phase 1 multi-center,
open-label, dose escalation study in adults with locally advanced
or metastatic epithelial-derived solid tumors refractory to
standard of care therapy, or those deemed ineligible or refused
another existing treatment option. The study will evaluate the
safety, tolerability, and preliminary efficacy of P-MUC1C-ALLO1 and
will follow a 3+3 design of dose-escalating cohorts. After a
subject enrolls, P-MUC1C-ALLO1 allogeneic CAR-T cells will be
administered, following a standard chemotherapy-based conditioning
regimen. The study protocol allows for exploration of additional
dosing regimens, including re-dosing once initial safety has been
established.
About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic
CAR-T product candidate in preclinical development for multiple
solid tumor indications. P-MUC1C-ALLO1 has the potential to treat a
wide range of solid tumors derived from epithelial cells, such as
breast, colorectal, lung, ovarian, pancreatic and renal cancers, as
well as other cancers expressing a cancer-specific form of the
Mucin 1 protein, or MUC1C. P-MUC1C-ALLO1 is designed to be fully
allogeneic, with genetic edits to eliminate or reduce both
host-vs-graft and graft-vs-host alloreactivity. Poseida has
demonstrated the elimination of tumor cells to undetectable levels
in preclinical models of both triple-negative breast and ovarian
cancer.
About Poseida Therapeutics, Inc.
Poseida Therapeutics
is a clinical-stage biopharmaceutical company dedicated to
utilizing our proprietary genetic engineering platform technologies
to create next generation cell and gene therapeutics with the
capacity to cure. We have discovered and are developing a broad
portfolio of product candidates in a variety of indications based
on our core proprietary platforms, including our non-viral
piggyBac® DNA Delivery System, Cas-CLOVER™ Site-specific Gene
Editing System and nanoparticle- and AAV-based gene delivery
technologies. Our core platform technologies have utility, either
alone or in combination, across many cell and gene therapeutic
modalities and enable us to engineer our portfolio of product
candidates that are designed to overcome the primary limitations of
current generation cell and gene therapeutics. To learn more, visit
www.poseida.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
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, the
potential benefits of Poseida's technology platforms and product
candidates, Poseida's plans and strategy with respect to developing
its technologies and product candidates, and anticipated timelines
and milestones with respect to Poseida's development programs and
manufacturing activities. 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 Poseida'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, risks and uncertainties associated with development and
regulatory approval of novel product candidates in the
biopharmaceutical industry and the other risks described in
Poseida'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. Poseida undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made,
except as required by law.
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SOURCE Poseida Therapeutics, Inc.