FDA evaluated RMAT application based on
positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1;
new clinical data from the study will be presented at the
21st International Myeloma Society Annual Meeting
this month
RMAT designation recognizes potential of
P-BCMA-ALLO1 to address significant unmet needs of multiple myeloma
patients and enables increased dialogue with FDA throughout the
development process
SAN
DIEGO, Sept. 16, 2024 /PRNewswire/ -- Poseida
Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell
therapy and genetic medicines company advancing differentiated
non-viral treatments for patients with cancer and rare diseases,
today announced that the U.S. Food and Drug Administration (FDA)
granted Regenerative Medicine Advanced Therapy (RMAT) designation
to P-BCMA-ALLO1, an investigational stem cell memory T cell
(TSCM)-based allogeneic CAR-T cell therapy in Phase
1/1b clinical development for the
treatment of patients with relapsed/refractory multiple
myeloma.
RMAT designation includes all the benefits of the Fast Track and
Breakthrough Therapy designation programs, including early
interactions with the FDA. Poseida's RMAT application was evaluated
based on encouraging early data from its ongoing Phase 1 study
of P-BCMA-ALLO1, which demonstrated P-BCMA-ALLO1's potential to
offer promising efficacy, safety profile and rapid 'off-the-shelf'
patient access.
"The RMAT designation for P-BCMA-ALLO1, our lead program, is
based on impressive early clinical data from our ongoing Phase 1
study and further validates its potential to address the unmet
needs of patients with relapsed/refractory multiple myeloma," said
Kristin Yarema, Ph.D., president and
chief executive officer of Poseida Therapeutics. "Importantly, our
data has shown clinical responses in very sick, refractory
patients, including those that have received prior BCMA-targeted
therapies. With both RMAT and Orphan Drug designations for
P-BCMA-ALLO1, we look forward to working closely with the FDA as we
continue to advance this next-generation, off-the shelf allogeneic
CAR-T therapy, including the recently initiated Phase 1b portion of the trial."
The Company will report new clinical data from the P-BCMA-ALLO1
Phase 1 study in an oral session at the 21st
International Myeloma Society Annual Meeting, which is being held
in Rio de Janeiro from
September 25-28, 2024. Additional
clinical updates are planned for the second half of 2024, subject
to coordination with Roche, which has a strategic collaboration
with Poseida covering multiple investigational allogeneic CAR-T
therapies targeting blood cancers, including P-BCMA-ALLO1.
The RMAT designation is a program under the
21st Century Cures Act that is intended to expedite
the development and review of regenerative medicine therapies for
serious or life-threatening diseases or conditions. A regenerative
medicine therapy is eligible for RMAT designation if it is intended
to treat, modify, reverse or cure a serious or life-threatening
disease or condition, and preliminary clinical evidence indicates
that the regenerative medicine therapy has the potential to address
unmet medical needs for such disease or condition.
RMAT designation includes all Breakthrough Therapy designation
features, including early interactions to discuss any potential
surrogate or intermediate endpoints. RMATs may be eligible for
accelerated approval based on previously agreed-upon surrogate or
intermediate endpoints that are reasonably likely to predict
long-term clinical benefit, or reliance upon data obtained from a
meaningful number of sites, including through expansion to
additional sites, as appropriate.
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 T stem cell
(TSCM)-rich allogeneic CAR-Ts have the potential to
offer effective, safe, and reliable treatment addressing unmet
needs in multiple myeloma. The FDA has granted P-BCMA-ALLO1
Regenerative Medicine Advanced Therapy (RMAT) designation for adult
patients with relapsed/refractory multiple myeloma after three or
more prior lines of therapies including a proteasome inhibitor
(PI), an immunomodulatory agent (IMiD), and anti-CD38 antibody in
addition to Orphan Drug designation for multiple myeloma.
Additional information about the Phase 1/1b study is available at
www.clinicaltrials.gov using identifier: NCT04960579.
About Poseida Therapeutics, Inc.
Poseida
Therapeutics is a clinical-stage biopharmaceutical company
advancing differentiated allogeneic cell therapies and genetic
medicines with the capacity to cure certain cancers and rare
diseases. The Company's pipeline includes investigational
allogeneic CAR-T cell therapies for both solid tumors and
hematologic cancers as well as investigational in vivo genetic
medicines that address patient populations with high unmet medical
need. The Company's approach 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 gene delivery technologies, as well as in-house GMP
cell therapy manufacturing. The Company has formed strategic
collaborations with Roche and Astellas to unlock the promise of
cell therapies for cancer patients. 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
potential benefits from receiving Regenerative Medicine Advanced
Therapy 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; 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.
