Data Describing Activity of P-BCMA-ALLO1 in
BCMA-Experienced Patients to be Presented at Upcoming AACR
Meeting
SAN
DIEGO, March 13, 2024 /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 the U.S. Food
and Drug Administration (FDA) has granted Orphan Drug Designation
for the treatment of multiple myeloma to P-BCMA-ALLO1, a
novel BCMA-targeted allogeneic, T stem cell memory
(TSCM)-rich chimeric antigen receptor (CAR)-T therapy
candidate. The Company is investigating P-BCMA-ALLO1 in partnership
with Roche for the treatment of relapsed/refractory multiple
myeloma (RRMM).
"The Orphan Drug Designation for P-BCMA-ALLO1 underscores the
high unmet medical need for a rapid and accessible off-the-shelf
allogeneic CAR-T therapy for patients with multiple myeloma," said
Kristin Yarema, Ph.D., President and
Chief Executive Officer of the Company. "This designation further
validates our belief that TSCM-rich allogeneic CAR-T
therapies may potentially offer the optimal combination of clinical
results, on-demand availability, and high-volume production, while
supporting broader access to CAR-T therapies. We look forward to
continuing our work on the Phase 1 study of P-BCMA-ALLO1 and plan
to share further clinical updates in 2024."
The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1
clinical trial and recently shared positive early safety and
preliminary efficacy data at the 65th American Society
of Hematology (ASH) Annual Meeting and Exposition in December 2023. Data highlighted at the meeting
showed that P-BCMA-ALLO1 was a well-tolerated off-the-shelf therapy
with a favorable emerging safety profile, delivered to 100% of
patients in the intent-to-treat population with no use of bridging
chemotherapy or other anti-myeloma bridging therapies. Preliminary
data presented at ASH also showed allogeneic TSCM-rich
CAR-T cells trafficking to bone marrow, differentiating to
cell-killing effector T cells and persisting at least 6 weeks after
treatment, which support the hypothesis of cell persistence at
tumor-relevant sites.
The Company will present data on a subset of recently enrolled
patients refractory to initial BCMA targeting therapy in a poster
presentation at the American Association for Cancer Research (AACR)
Annual Meeting in San Diego on
April 8, 2024, 9:00 AM to 12:30 PM PT.
Subject to coordination with Roche, the Company plans to provide
an additional clinical update on the P-BCMA-ALLO1 program at a
scientific meeting in the second half of 2024.
The FDA's Orphan Drug Designation program provides orphan status
to drugs or biologics intended for the prevention, diagnosis, or
treatment of diseases that affect fewer than 200,000 people in
the United States. Sponsors of
medicines that are granted Orphan Drug Designation are entitled to
certain incentives, including tax credits for qualified clinical
trials, prescription drug user-fee exemptions, and potential
seven-year marketing exclusivity upon FDA approval.
About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed
to Roche targeting B-cell maturation antigen (BCMA) for the
treatment of relapsed/refractory multiple myeloma. This allogeneic
program includes a VH-based binder that targets BCMA and clinical
data presented at ASH in December
2023 support the Company's belief that TSCM-rich
allogeneic CAR-Ts have the potential to offer effective, safe, and
reliable treatment addressing unmet needs in multiple myeloma.
Additional information about the Phase 1 study is available
at www.clinicaltrials.gov using identifier:
NCT04960579.
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, Booster Molecule, and
nanoparticle and hybrid gene delivery technologies as well as
in-house GMP cell therapy manufacturing. The Company has formed a
global strategic collaboration with Roche to unlock the promise of
cell therapies for patients with hematological malignancies. Learn
more at www.poseida.com and connect with Poseida on X 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, 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, including the efficacy and safety profile of
such product candidates; the quote from Dr. Yarema; the Company's
ability to exploit and consummate additional business development
opportunities; the Company's ability to attract and/or retain new
and existing collaborators with relevant expertise and its
expectations regarding the potential benefits to be derived from
any such collaborations; potential benefits from receiving Orphan
Drug Designation for P-BCMA-ALLO1; 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 the 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
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.
