– PRGN-2012 is on track for a rolling BLA
submission under an accelerated approval pathway; patient
enrollment initiated in the confirmatory clinical trial
–
GERMANTOWN, Md., Aug. 6, 2024
/PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical
company specializing in the development of innovative gene and cell
therapies to improve the lives of patients, today announced a
strategic reprioritization of the Company's clinical portfolio and
streamlining of resources, including a reduction of over 20% of its
workforce, to focus on potential commercialization of the PRGN-2012
AdenoVerse® gene therapy for the treatment
of recurrent respiratory papillomatosis (RRP).
These strategic changes substantially reduce required resources
for non-priority programs and will enable the Company to focus on
pre-commercialization efforts on PRGN-2012, including supporting
submission of a rolling biologics license application (BLA) under
an accelerated approval pathway anticipated in the second half of
2024, conducting the confirmatory clinical trial, and manufacturing
of commercial product. Additionally, the Company will continue
acceleration of commercial readiness efforts for a potential launch
in 2025, led by the Company's new Chief Commercial Officer,
Phil Tennant.
Strategic prioritization will also include:
- PRGN-2009 AdenoVerse® Gene
Therapy Clinical Trials: The Company plans to continue
PRGN-2009 Phase 2 trials under a cooperative research and
development agreement (CRADA) with the National Cancer Institute
(NCI) in recurrent/metastatic cervical cancer and in newly
diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 clinical
trial enrollment at non-NCI clinical sites will be paused.
- UltraCAR-T® Clinical
Programs: The Company has completed enrollment of the
Phase 1b trial for PRGN-3006 in acute
myeloid leukemia (AML), which received Fast Track designation from
the US Food and Drug Administration (FDA), and is preparing for an
end of Phase 1b meeting with the FDA
to discuss next steps. The Company will pause all
other UltraCAR-T clinical programs, including PRGN-3005 and
PRGN-3007. The Company will minimize UltraCAR-T spend and focus on
strategic partnerships to further advance UltraCAR-T programs.
- Preclinical Programs: The Company will pause all
preclinical programs.
- ActoBio: The Company has initiated a shutdown of
its Belgium-based ActoBio
subsidiary operations, including planned elimination of all ActoBio
personnel. In conjunction with this shutdown, ActoBio's portfolio
of intellectual property will be made available for prospective
transactions.
"We are on track toward our goal of submitting a rolling BLA for
PRGN-2012 in the second half of this year and we are pleased to
announce that the confirmatory clinical trial, an important step
guided by the FDA to support an accelerated approval, has already
been initiated and is actively enrolling patients," said
Helen Sabzevari, PhD, President and
CEO of Precigen. "These prioritization steps enhance our ability to
rapidly prepare for potential commercialization of PRGN-2012, which
if approved, we believe has the safety, efficacy, and route of
administration profile to be the first and best-in-class therapy
for RRP patients."
Please refer to the Company's 8-K filing for additional
details.
Precigen: Advancing Medicine with
Precision™
Precigen (Nasdaq: PGEN) is a dedicated
discovery and clinical stage biopharmaceutical company advancing
the next generation of gene and cell therapies using precision
technology to target the most urgent and intractable diseases in
our core therapeutic areas of immuno-oncology, autoimmune
disorders, and infectious diseases. Our technologies enable us to
find innovative solutions for affordable biotherapeutics in a
controlled manner. Precigen operates as an innovation engine
progressing a preclinical and clinical pipeline of
well-differentiated therapies toward clinical proof-of-concept and
commercialization. For more information about Precigen, visit
www.precigen.com or follow us on X @Precigen, LinkedIn or
YouTube.
AdenoVerse®
Precigen's AdenoVerse platform
utilizes a library of proprietary adenovectors for the efficient
gene delivery of therapeutic effectors, immunomodulators, and
vaccine antigens designed to modulate the immune system. Precigen's
gorilla adenovectors, part of the AdenoVerse library, have
potentially superior performance characteristics as compared to
current competition. AdenoVerse gene therapies have been shown to
generate high-level and durable antigen-specific T-cell immune
responses as well as an ability to boost these responses via repeat
administration. Superior performance characteristics and high yield
manufacturing of AdenoVerse vectors leveraging
UltraVector® technology allows Precigen to engineer
cutting-edge investigational gene therapies to treat complex
diseases.
About PRGN-2012 AdenoVerse® Gene
Therapy
PRGN-2012 is an investigational off-the-shelf
AdenoVerse gene therapy designed to elicit immune responses
directed against cells infected with human papillomavirus (HPV) 6
or HPV 11 for the treatment of RRP. PRGN-2012 was the first to
receive Breakthrough Therapy Designation and an accelerated
approval pathway for RRP from the US Food and Drug Administration
(FDA). PRGN-2012 received Orphan Drug Designation from the
FDA and from the European Commission. Results from the Phase 1
portion of the Phase 1/2 study were published in the peer-reviewed
journal, Science Translational Medicine, a leading
publication from the American Association for the Advancement of
Science (AAAS). Pivotal data was presented at the 2024 American
Society of Clinical Oncology annual meeting.
Trademarks
Precigen, AdenoVerse, UltraVector, and
Advancing Medicine with Precision are trademarks of Precigen and/or
its affiliates.
Cautionary Statement Regarding Forward-Looking
Statements
Some of the statements made in this press release
are forward-looking statements. These forward-looking statements
are based upon the Company's current expectations and projections
about future events and generally relate to plans, objectives, and
expectations for the development of the Company's business, the
Company's ability to successfully partner or sell its paused
programs and activities in a timely manner, the timing and progress
of clinical trials, and related milestones including BLA submission
and potential launch of PRGN-2012, and the promise of the Company's
portfolio of therapies. Although management believes that the plans
and objectives reflected in or suggested by these forward-looking
statements are reasonable, all forward-looking statements involve
risks and uncertainties and actual future results may be materially
different from the plans, objectives and expectations expressed in
this press release. The Company has no obligation to provide any
updates to these forward-looking statements even if its
expectations change. All forward-looking statements are expressly
qualified in their entirety by this cautionary statement. For
further information on potential risks and uncertainties, and other
important factors, any of which could cause the Company's actual
results to differ from those contained in the forward-looking
statements, see the section entitled "Risk Factors" in the
Company's most recent Annual Report on Form 10-K and subsequent
reports filed with the Securities and Exchange Commission.
Investor Contact:
Steven M.
Harasym
Vice President, Investor Relations
Tel: +1 (301) 556-9850
investors@precigen.com
Media Contacts:
Donelle M.
Gregory
press@precigen.com
Glenn Silver
Lazar-FINN Partners
glenn.silver@finnpartners.com
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SOURCE Precigen, Inc.