– PRGN-2012 Phase 2 pivotal study
data in RRP is anticipated in the second quarter of 2024; the
Company plans to submit a BLA under an accelerated approval
pathway in the second half of 2024; commercial readiness
preparations are underway for a potential launch in
2025 –
– Company presentation scheduled
for January 10 at 5:15 PM PST –
GERMANTOWN, Md., Jan. 8, 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 released highlights of pipeline updates to be
presented at the 42nd Annual J.P. Morgan Healthcare Conference
on January 10, 2024 at 5:15 PM PST in San
Francisco, California.
AdenoVerse™ Immunotherapies
"In the
second quarter of this year, we anticipate presenting Phase 2
pivotal study data for our lead asset, PRGN-2012, in recurrent
respiratory papillomatosis, RRP, and submitting the Company's
first BLA under an accelerated approval pathway in the second half
of this year. In anticipation of a potential launch in 2025, we are
actively preparing for commercial readiness. This is an
exciting time for Precigen as we prepare to transition from a
clinical to commercial stage biotechnology company. I am incredibly
proud of the Precigen team for achieving the first breakthrough
therapy designation and accelerated approval pathway so rapidly for
an RRP treatment and for the life-changing potential that
PRGN-2012 has for RRP patients," said Helen Sabzevari, PhD, President and CEO of
Precigen.
- PRGN-2012 in RRP: PRGN-2012 is an investigational
off-the-shelf AdenoVerse immunotherapy designed to elicit immune
responses directed against cells infected with human papillomavirus
(HPV) 6 or HPV 11 for the treatment of RRP. The US Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation
and Orphan Drug Designation for PRGN-2012 for the treatment of RRP.
- PRGN-2012 is currently under investigation in a Phase 1/2
pivotal single-arm study in adult patients with RRP (clinical trial
identifier: NCT04724980).
- PRGN-2012 demonstrated strong efficacy and favorable safety
profile in the Phase 1 portion of the study with 50% of patients
(N=12) in durable and ongoing Complete Response more than two years
after PRGN-2012 treatment.
- A Phase 2 data presentation is anticipated in the second
quarter of 2024.
- A planned Biologics License Application (BLA) submission under
an accelerated approval pathway is anticipated in the second half
of 2024.
- Commercial readiness preparations are underway for a potential
launch in 2025.
- PRGN-2009 in OPSCC and Cervical Cancer:
PRGN-2009 is an investigational off-the-shelf AdenoVerse
immunotherapy designed to activate the immune system to recognize
and target HPV-associated cancers.
- The Phase 2 study of PRGN-2009 in combination with
pembrolizumab in newly diagnosed patients with HPV-associated
oropharyngeal squamous cell carcinoma (OPSCC) is currently
enrolling patients (clinical trial identifier: NCT05996523).
- The Phase 2 randomized, open-label study of PRGN-2009 in
combination with pembrolizumab in patients with
recurrent/metastatic cervical cancer is anticipated to initiate in
the first quarter of 2024 (clinical trial identifier:
NCT06157151).
UltraCAR-T® Cell Therapies
"We continue to
advance our UltraCAR-T clinical programs and remain
enthusiastic about the data we are seeing in our Phase 1b expansion studies. Precigen's UltraCAR-T cell
therapies are engineered to specifically address the limitations of
conventional CAR-T therapies by improving in vivo CAR-T
expansion and persistence, adding a safety/kill switch to reduce
the risk of toxicity and malignancy, utilizing a non-viral design
to reduce the risk of malignant transformation associated with
lentivirus and retrovirus vectors, eliminating long turnaround
times for manufacturing and reducing the high cost of treatment,"
adds Sabzevari. "We look forward to sharing new results for these
assets during the planned presentations for our PRGN-3006 and
PRGN-3007 UltraCAR-T programs in 2024. In addition to ongoing
clinical trials, we are excited by the preclinical data for a new
and differentiated CD19 targeted UltraCAR-T, which has
best-in-class potential for this validated target capitalizing on
the unique advantages of the UltraCAR-T platform over conventional
CAR-T."
- PRGN-3006 in AML/MDS: PRGN-3006 is an
investigational multigenic, autologous chimeric antigen receptor T
cell (CAR-T) therapy engineered to simultaneously express a CAR
specifically targeting CD33, membrane bound IL-15 (mbIL15), and a
safety/kill switch. PRGN-3006 has been granted Orphan Drug
Designation in patients with acute myeloid leukemia (AML) and
Fast Track Designation in patients with relapsed/refractory
(r/r) AML by the FDA.
- PRGN-3006 is currently under evaluation in a Phase 1b clinical trial (clinical trial identifier:
NCT03927261) for the treatment of patients with r/r AML or
higher-risk myelodysplastic syndromes (MDS).
- The first-in-human, Phase 1 dose escalation portion of the
study with lymphodepletion was completed in r/r AML and higher-risk
MDS patients.
- Phase 1 dose escalation data showed that PRGN-3006 was
well-tolerated with no dose-limiting toxicities (DLTs) and a 27%
objective response rate (ORR) in heavily pre-treated r/r AML
patients infused following lymphodepletion.
- An interim Phase 1b dose
expansion data presentation is anticipated in the second half of
2024.
- PRGN-3005 in Ovarian Cancer: PRGN-3005 is an
investigational multigenic, autologous CAR-T cell therapy
engineered to express a CAR specifically targeting the unshed
portion of MUC16, mbIL15, and a safety/kill switch.
- The Phase 1b dose expansion
portion of the Phase 1/1b study is
ongoing (clinical trial identifier: NCT03907527).
- PRGN-3007 in Advanced ROR1+ Hematological and Solid
Tumors: PRGN-3007 is an investigational multigenic,
autologous CAR-T cell therapy engineered to express a CAR targeting
receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a
safety/kill switch, and a novel mechanism for the intrinsic
blockade of PD-1 gene expression.
- The Phase 1 dose escalation portion of the Phase 1/1b study is ongoing (clinical trial identifier:
NCT05694364).
- A preliminary Phase 1 dose escalation data presentation is
anticipated by the end of 2024.
- UltraCAR-T Targeting CD19: Preclinical data for the
Company's UltraCAR-T targeting CD19 (a validated target) have
demonstrated significant potential and the Company is preparing to
initiate a Phase 1 study to support a potential best-in-class CD19
CAR-T leveraging the unique advantages of the UltraCAR-T
platform.
Precigen's 42nd Annual J.P. Morgan Healthcare
Conference presentation will be available on the Company website in
the Events & Presentations section following the
presentation.
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.
Trademarks
Precigen, UltraCAR-T, UltraPorator,
AdenoVerse and Advancing Medicine with Precision are trademarks
of Precigen and/or its affiliates. Other names may be
trademarks of their respective owners.
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,
including the timing and progress of preclinical studies, clinical
trials, discovery programs, product candidate approval and
commercialization and related milestones, the promise of the
Company's portfolio of therapies, and in particular its CAR-T and
AdenoVerse 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.