SAN DIEGO, Jan. 10, 2022 /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 the appointment of Eric Ostertag as Executive Chairman and the
transition of current President and Chief Business Officer,
Mark Gergen, to the role of Chief
Executive Officer effective as of February
1, 2022. The Company also provided a summary business update
and 2022 preview.
Poseida announces President Mark
Gergen to serve as CEO, effective 2/1. Eric Ostertag named Executive Chairman.
$PSTX
"For the last four years, Mark and I have worked closely to
build Poseida into the organization it is today, making tremendous
progress on a wide variety of initiatives which includes taking the
company public in 2020, and preparing for the next wave of growth
that lies ahead," said Eric
Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida
Therapeutics. "Going forward, Mark will assume the overall
leadership of the company while I will focus on high-level
strategy, intended to maximize the value of our differentiated
genetic engineering platforms and product candidates. In addition
to continuing to chair the board of directors, I will also work to
expand and further develop our scientific advisory boards."
As Poseida's founder and CEO, Ostertag directed the Company's
spin out in early 2015 from parent company Transposagen
Biopharmaceuticals, Inc., a biotechnology company that
commercialized gene editing technology in research applications.
Ostertag also founded Transposagen, where he was CEO from 2003 to
2015. Ostertag earned his M.D. and Ph.D. from the University of Pennsylvania. Under his leadership,
Poseida grew to over 250 employees, raised significant private
capital and successfully completed an IPO in 2020. The Company has
also built a significant global intellectual property portfolio;
received FDA clearance on four Investigational New Drug (IND)
applications for novel cell therapies, dosing over 100 patients in
clinical trials; and established multiple collaborations, including
the recently announced gene therapy collaboration with Takeda
Pharmaceutical Company Limited ("Takeda"), which has a potential
total value of up to $3.6
billion.
"It is a privilege to take on the role of CEO and lead the
organization as we continue our progress toward our mission to
redefine cell and gene therapy. The partnership Eric and I have
built in guiding the company will continue," said Mark Gergen, Poseida's President and Chief
Business Officer. "I am very excited about 2022 and the
opportunities we will have to differentiate our platforms in both
cell and gene therapy. We are highly focused on getting to key
inflection points on our solid tumor and allogeneic CAR-T programs
as well as advancing our gene therapy efforts, including those
associated with our recent collaboration with Takeda."
Gergen joined Poseida in February
2018, serving as Chief Business Officer and Chief Financial
Officer before being appointed President and Chief Business Officer
in July 2020. During his career in
the biotech and pharmaceutical industries, Gergen has provided
strategic leadership to companies as they scale, grow, and execute
on the promise of their technologies. Before joining Poseida, he
held key leadership roles including that of Senior Vice President
and Chief Operating Officer of Halozyme, Inc., Executive Vice
President and Chief Operating Officer at Mirati Therapeutics, Inc.
and as Senior Vice President of Corporate Development at Amylin
Pharmaceuticals, Inc. He has also served in senior management
positions at CardioNet Inc., Advanced Tissue Sciences, Inc., and
Medtronic, Inc. Gergen received a J.D. from the University of Minnesota Law School and a B.A. in
business administration from Minot State
University in North
Dakota.
Both Ostertag and Gergen will continue to serve as members of
the Company's Board of Directors.
Business Update and 2022 Preview
Annual R&D Day
The Company will soon host its
second annual R&D Day, scheduled for Wednesday, February 23, 2022. Dr. Ostertag
will lead the event, featuring presentations highlighting the
current product pipeline, advancements in early discovery and
research programs, and detailing novel next generation approaches
and technology applications. To register for the webcast, please
visit the Investor Relations section of the Poseida website.
P-PSMA-101 Autologous CAR-T for Prostate Cancer
A
Phase 1 trial evaluating P-PSMA-101, the Company's autologous CAR-T
candidate for the treatment of metastatic castrate resistant
prostate cancer (mCRPC) is ongoing. Initial clinical data was
presented in late August 2021 at the
CAR-TCR Summit demonstrating encouraging early results at low doses
in this difficult to treat patient population with high unmet
need. The Company will be presenting additional data during
the ASCO Genitourinary Cancers Symposium taking place February 17-19, 2022, in a poster titled, "Phase
1 study of P-PSMA-101 CAR-T cells in patients with metastatic
castration-resistant prostate cancer (mCRPC)."
P-BCMA-ALLO1 Allogeneic CAR-T for R/R Multiple
Myeloma
The Phase 1 trial of P-BCMA-ALLO1, an allogeneic
CAR-T product candidate for the treatment of relapsed refractory
multiple myeloma, is currently initiating with a clinical data
update expected later in the year. In addition to the continued
product manufacturing at the current contract manufacturing
organization, the Company is exploring a parallel path to enable
manufacturing of P-BCMA-ALLO1 at its in-house GMP manufacturing
pilot plant in San Diego,
following successful manufacturing runs of the allogeneic CAR-T
product candidate P-MUC1C-ALLO1.
P-MUC1C-ALLO1 Allogeneic CAR-T for Solid Tumors
The
Company announced on December 20,
2021 that the IND submitted for the P-MUC1C-ALLO1 product
candidate had been cleared by the FDA. The Phase 1 clinical
trial start-up is underway and will evaluate P-MUC1C-ALLO1 in
various solid tumors, including breast, ovarian, lung and
colorectal cancers. P-MUC1C-ALLO1 is manufactured at the
Company's in-house GMP manufacturing pilot plant in San
Diego. Initial clinical data from P-MUC1C-ALLO1 is expected
to be presented at a scientific meeting this year.
Dual P-CD19CD20-ALLO1 Allogeneic Car T for B-cell
Malignancies
Due to the prioritization of the lead
allogeneic programs and the focus on achieving associated
milestones in 2022, the Company is shifting expectations for an IND
filing of its first dual CAR-T program from the end of 2022 into
2023.
P-OTC-101 In Vivo Liver Directed Gene Therapy for
OTC
The Company's leading internal gene therapy program,
P-OTC-101, an in vivo liver-directed gene therapy for ornithine
transcarbamylase (OTC) deficiency, continues with IND enabling
activities and evaluation of both a fully nanoparticle delivery
approach as well as a hybrid nanoparticle/AAV approach. A
decision of whether to pursue the fully nanoparticle or hybrid
approach going forward is expected by mid-year.
Partnerships and Collaborations
The Company's research
collaboration with Takeda focused on non–viral in vivo liver- and
HSC- directed gene therapies is underway. The collaboration,
announced in October 2021, provides
validation of Poseida's genetic engineering technology and
approach. In 2022, the Company will continue to evaluate and
explore additional opportunities for collaboration and partnership
enabled by the breadth and versatility of the piggyBac®,
Cas-CLOVER™, nanoparticle and other technology platforms.
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 Statement
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, future roles and
contributions of Poseida's executive officers, 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 statement 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-eric-ostertag-to-serve-as-executive-chairman-and-transition-role-of-ceo-to-current-president-and-cbo-mark-gergen-301456644.html
SOURCE Poseida Therapeutics, Inc.