Full Press Release Details
Precigen Strategically
Prioritizes Portfolio to Focus on First Potential
PRG-2012 is on track for a rolling BLA submission under an accelerated approval pathway;
patient enrollment initiated in the
confirmatory clinical trial -
MD, August 6, 2024 - 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:
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."
to the Company's 8-K filing for additional details.
Precigen: Advancing Medicine with Precision
(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.
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
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).
Precigen, AdenoVerse, UltraVector, and Advancing
Medicine with Precision are trademarks of Precigen and/or its affiliates.
Cautionary Statement Regarding Forward-Looking
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.
Vice President, Investor Relations
Tel: +1 (301) 556-9850