– Company achieved significant progress
for its clinical pipeline in 2022 –
–
Precigen to host R&D Day virtual event on January 24, 2023, at 4:30
PM ET to share safety and efficacy data from the Phase 1
dose escalation and expansion cohorts of PRGN-2012 AdenoVerse™
immunotherapy in recurrent respiratory papillomatosis (RRP)
–
GERMANTOWN, Md., Jan. 11,
2023 /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 presented pipeline and corporate updates at the
41st Annual J.P. Morgan Healthcare Conference. Helen
Sabzevari, PhD, President and CEO of Precigen, presented a
summary of 2022 achievements and set
forth Precigen's goals for 2023.
"Precigen continued to make significant clinical progress for
our UltraCAR-T and AdenoVerse programs in 2022 and we were able to
meet or exceed substantially all of the clinical goals we outlined
at the J.P. Morgan Healthcare Conference last year. For
example, the PRGN-2012 study in RRP continues to accelerate at a
rapid pace and we look forward to hosting an R&D update call on
January 24th to share safety and
efficacy data from the Phase 1 dose escalation and expansion
cohorts," said Helen Sabzevari, PhD,
President and CEO of Precigen. "In 2023, we will continue to
advance our clinical programs with a focus on a rapid path to
licensure for programs addressing high unmet patient need."
PRGN-2012 AdenoVerse™ Immunotherapy in
RRP
- Overview: PRGN-2012 is an investigational
off-the-shelf (OTS) AdenoVerse immunotherapy designed to elicit
immune responses directed against cells infected with HPV 6 or HPV
11 for treatment of RRP. PRGN-2012 is currently under evaluation in
a Phase 2 clinical trial (clinical trial identifier: NCT04724980).
The clinical trial evaluates PRGN-2012 as an adjuvant immunotherapy
following standard-of-care surgical removal of visible papillomas
in adult patients with RRP. PRGN-2012 has been granted Orphan
Drug Designation in patients with RRP by the US Food and Drug
Administration (FDA).
- Program Status: Enrollment (N=15) was completed in
the Phase 1 study. Precigen initiated dosing in the Phase 2 trial
and is rapidly enrolling patients, with 20 patients enrolled to
date. The Company will host a virtual R&D event on January 24, 2023 to showcase complete
clinical trial data from the Phase 1 dose escalation and expansion
cohorts of PRGN-2012 AdenoVerse Immunotherapy in RRP. The
event will be led by Clint T. Allen,
MD, Senior Investigator, Surgical Oncology Program, Center for
Cancer Research, National Cancer Institute (NCI) and lead associate
investigator for the PRGN-2012 clinical trial and Helen Sabzevari, PhD, President and CEO of
Precigen. The Company plans to outline the regulatory strategy for
PRGN-2012 in 2023 based on discussions with the FDA.
PRGN-2009 AdenoVerse™ Immunotherapy in
HPV-associated Cancers
- Overview: PRGN-2009 is
an OTS investigational immunotherapy utilizing the
AdenoVerse platform designed to activate the immune system to
recognize and target HPV-positive (HPV+) solid tumors. PRGN-2009 is
currently under evaluation in a Phase 1/2 clinical trial (clinical
trial identifier: NCT04432597). The Phase 1 trial is evaluating
safety and response of PRGN-2009 as a monotherapy (Arm A) and in
combination with M7824 (Arm B) in previously treated patients with
recurrent or metastatic HPV-associated cancers.
- Program Status: Enrollment was completed in the
Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in
patients with recurrent or metastatic HPV-associated cancers and
patient follow up is ongoing. The Company expects Phase 1
monotherapy and combination therapy safety and efficacy data to be
presented in the first half of 2023. Enrollment is nearing
completion in the Phase 2 monotherapy arm in newly diagnosed
oropharyngeal squamous cell carcinoma (OPSCC) patients with 19 of
20 estimated patients enrolled as of the end of 2022. Interim
clinical data presentation from the Phase 2 monotherapy arm is
expected in the second half of 2023.
PRGN-3006 UltraCAR-T® in Acute
Myeloid Leukemia (AML)
- Overview: 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 kill switch.
PRGN-3006 UltraCAR-T is under evaluation in a Phase 1b clinical trial (clinical trial identifier:
NCT03927261) for the treatment of patients with relapsed or
refractory AML or higher-risk myelodysplastic syndromes (MDS).
PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation
in patients with AML and Fast Track Designation in patients with
relapsed/refractory AML by the FDA.
- Program Status: Enrollment was completed in the Phase 1
dose escalation cohorts of the study.
Precigen presented positive Phase 1 dose escalation data
for autologous PRGN-3006 UltraCAR-T® manufactured overnight for
next day infusion in relapsed or refractory AML patients at
the 64th American Society of Hematology (ASH) Annual
Meeting and Exposition. The Phase 1b
dose expansion study of PRGN-3006 UltraCAR-T was expanded to Mayo
Clinic in Rochester, Minnesota,
enhancing the decentralized manufacturing model. The first patient
was successfully dosed at the expansion site with PRGN-3006
UltraCAR-T. Site activation activities are in progress at several
additional major cancer centers across the US as part of the
multicenter expansion of the study. The Company received FDA
clearance to incorporate repeat dosing in the Phase 1b expansion phase of the study, at the
discretion of the treating physician. Phase 1b clinical trial data presentation is expected
in 2024.
PRGN-3005 UltraCAR-T® in
Ovarian Cancer
- Overview: PRGN-3005 UltraCAR-T is an
investigational multigenic, autologous CAR-T cell therapy
engineered to express a CAR specifically targeting the unshed
portion of MUC16, which is highly expressed on ovarian tumors with
limited normal tissue expression, mbIL15, and a kill switch.
PRGN-3005 UltraCAR-T is under evaluation in a Phase 1b clinical trial (clinical trial identifier:
NCT03907527) for the treatment of patients with advanced, recurrent
platinum-resistant ovarian cancer.
- Program Status: Enrollment was completed in the
Phase 1 dose escalation cohorts of the intraperitoneal (IP) and
intravenous (IV) arms without lymphodepletion as well as in the
lymphodepletion cohort in the IV arm. Patient follow up is
ongoing and the Company expects Phase 1 data to be presented in the
first half of 2023. The first patient received a repeat PRGN-3005
dose via IV infusion, following FDA clearance to incorporate
repeat dosing in the study protocol. Enrollment is ongoing in the
Phase 1b expansion study of PRGN-3005
UltraCAR-T at Dose Level 3 with lymphodepletion prior to IV
infusion. Site activation activities are in progress at multiple
major cancer centers in the US. Phase 1b clinical trial data presentation is expected
in 2024.
PRGN-3007 Next Generation
UltraCAR-T® with Intrinsic PD-1
Inhibition
- Overview: PRGN-3007, based on the next generation
of the UltraCAR-T platform, is an investigational multigenic,
autologous CAR-T cell therapy engineered to simultaneously express
a CAR targeting receptor tyrosine kinase-like orphan receptor 1
(ROR1), mbIL15, a kill switch, and a novel mechanism for the
intrinsic blockade of PD-1 gene expression. ROR1 is aberrantly
expressed in multiple hematological tumors, including chronic
lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute
lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma
(DLBCL) and solid tumors, including breast adenocarcinomas such as
triple negative breast cancer (TNBC), pancreatic cancer, ovarian
cancer, and lung adenocarcinoma. ROR1 is minimally expressed in
healthy adult tissues.
- Program Status: Precigen presented an abstract titled,
"A Phase1/1b Dose Escalation/Dose
Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients with
Advanced Hematologic and Solid Tumor Malignancies," at ASH. Tech
transfer was completed for initiation of the Phase 1 umbrella trial
in ROR1+ hematological (CLL, MCL, ALL, DLBCL) and solid
tumors (TNBC). The trial is currently open for enrollment and the
Company expects to dose the first patient in the first quarter of
2023.
Precigen's J.P. Morgan presentation is available on the Company
website in the Events & Presentations section.
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 Twitter @Precigen,
LinkedIn or YouTube.
UltraCAR-T®
UltraCAR-T is a multigenic
autologous CAR-T platform that utilizes Precigen's advanced
non-viral Sleeping Beauty system to simultaneously express an
antigen-specific CAR to specifically target tumor cells, mbIL15 for
enhanced in vivo expansion and persistence, and a kill switch to
conditionally eliminate CAR-T cells for a potentially improved
safety profile. Precigen has advanced the UltraCAR-T platform to
address the inhibitory tumor microenvironment by incorporating a
novel mechanism for intrinsic checkpoint blockade without the need
for complex and expensive gene editing techniques. UltraCAR-T
investigational therapies are manufactured via Precigen's overnight
manufacturing process using the proprietary UltraPorator®
electroporation system at the medical center and administered to
patients only one day following gene transfer. The overnight
UltraCAR-T manufacturing process does not use viral vectors and
does not require ex vivo activation and expansion of T cells,
potentially addressing major limitations of current T cell
therapies.
AdenoVerse™ Immunotherapy
Precigen's
AdenoVerse immunotherapy 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
immunotherapies have been shown to generate high-level and durable
antigen-specific neutralizing antibodies and effector T cell immune
responses as well as an ability to boost these antibody and T cell
responses via repeat administration. Superior performance
characteristics and high yield manufacturing of AdenoVerse vectors
combined with UltraVector® technology allows Precigen to engineer
cutting-edge investigational gene therapies to treat complex
diseases.
UltraPorator®
The UltraPorator system is an
exclusive device and proprietary software solution for the scale-up
of rapid and cost-effective manufacturing of UltraCAR-T therapies
and potentially represents a major advancement over current
electroporation devices by significantly reducing the processing
time and contamination risk. The UltraPorator device is a
high-throughput, semi-closed electroporation system for modifying T
cells using Precigen's proprietary non-viral gene transfer
technology. UltraPorator is being utilized for clinical
manufacturing of Precigen's investigational UltraCAR-T therapies in
compliance with current good manufacturing practices.
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 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, including the
possibility that the timeline for the Company's clinical trials
might be impacted by the COVID-19 pandemic, 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.