GERMANTOWN, Md., Aug. 5, 2019 /PRNewswire/ -- Precigen, Inc., a
wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a
biopharmaceutical company specializing in the development of
innovative gene and cellular therapies to improve the lives of
patients, today announced that the first patient has been dosed
with Precigen's PRGN-3005, a first-in-class investigational therapy
using Precigen's UltraCAR-T™ therapeutic platform. PRGN-3005
UltraCAR-T is an autologous chimeric antigen receptor T (CAR-T)
cell therapy manufactured using non-viral gene delivery and is
under investigation for the treatment of patients with advanced,
recurrent platinum resistant ovarian, fallopian tube or primary
peritoneal cancer (clinical trial identifier: NCT03907527).
PRGN-3005 utilizes Precigen's transformative UltraCAR-T
therapeutic platform, which eliminates ex vivo expansion and
reduces manufacturing time to allow for rapid next day
administration of UltraCAR-T cells following non-viral gene
transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell
investigational therapy utilizing Precigen's advanced non-viral
gene delivery system to co-express a chimeric antigen receptor,
membrane-bound interleukin‐15 (mbIL15), and a kill switch for
better precision and control.
"This is an important milestone in our efforts to develop a new
treatment option for patients with ovarian cancer," said
Helen Sabzevari, PhD, President of
Precigen. "With the first ovarian cancer patient dosed with
Precigen's PRGN-3005 UltraCAR-T investigational therapy, we remain
steadfast in our goal of delivering critical new therapies to solid
tumor patients with high unmet need."
Conducted in collaboration with the University of Washington and Fred Hutchinson Cancer
Research Center, the PRGN-3005 UltraCAR-T clinical study is an
open-label, first-in-human Phase 1 dose escalation study to
evaluate the safety and maximal tolerated dose of PRGN‐3005
UltraCAR-T delivered by intraperitoneal infusion (IP) or
intravenous infusion (IV). The study population includes patients
with advanced stage (III/IV) recurrent ovarian, fallopian tube, and
primary peritoneal cancer who are platinum-resistant and have
progressed after receiving standard-of-care therapies or are not
eligible to receive available therapies with known clinical
benefit.
"Many women with ovarian, fallopian tube and primary peritoneal
cancer have historically poor outcomes," said Mary L. (Nora) Disis, MD, faculty member at the
University of Washington and Fred
Hutchinson Cancer Research Center and one of the lead
investigators for the PRGN-3005 study. "Dosing the first
patient with the PRGN-3005 UltraCAR-T represents a potentially
significant development for the use of CAR-T cell therapies in
solid tumors."
About Ovarian Cancer
Worldwide, nearly 300,000 women
are diagnosed with ovarian cancer every year1 with
approximately 22,000 of them in the US2. Since early
ovarian cancer is often without obvious symptoms, the disease is
frequently diagnosed at an advanced stage where cancer has spread
to distant parts of the body, such as the liver or
lungs2,3. Five-year survival rates depend on stage and
type of ovarian cancer with rates decreasing for advanced stage
cancers that have spread to distant parts of the
body3.
Precigen : Advancing Medicine with
Precision™
Precigen is a dedicated discovery
and clinical stage biopharmaceutical company advancing the next
generation of gene and cellular therapies using precision
technology to target the most urgent and intractable diseases in
immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen also follows the science opportunistically in pursuit of
promising programs in emerging therapeutics. 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 unique therapies toward clinical
proof-of-concept and commercialization. Precigen was founded as a
wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and
leverages a diverse portfolio of technology platforms to advance
human health. For more information about Precigen, visit
www.precigen.com or follow us on Twitter @Precigen and
LinkedIn.
Precigen's UltraCAR-T™ Therapeutic
Platform
Precigen's UltraCAR-T platform has the potential to
disrupt the CAR-T treatment landscape by increasing patient access
through shortening manufacturing time, decreasing
manufacturing-related costs, and improving outcomes using advanced
approaches for precise tumor targeting and control of the immune
system. The platform brings several key advancements: 1) Non-viral
gene transfer using multigenic vectors for expression of multiple
effector genes leads to better precision and control of tumor
targeting and eliminates the need for virus; 2) Sustained
persistence and desired phenotype of infused UltraCAR-T helps
address T-cell exhaustion, a common issue with current CAR-T
therapies; 3) T-cell control by incorporation of kill switch
technology to potentially improve the safety profile; and 4) Rapid
manufacturing of UltraCAR-T cells using our proprietary non-viral
gene transfer process, which eliminates the need for ex vivo
propagation, thus dramatically reducing wait times for patients
from weeks to one day after gene transfer.
Safe Harbor Statement
Some of the statements made in
this press release are forward-looking statements. These
forward-looking statements are based upon our current expectations
and projections about future events and generally relate to plans,
objectives and expectations for the development of our business,
including the timing and progress of preclinical and clinical
trials and discovery programs. 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.
1World Health Organization, International Agency for
Research on Cancer, Global Cancer Observatory. Cancer Today,
Estimated number of new cases in 2018. Accessed July 2019 via WHO IARC GCO website.
2American Cancer Society Ovarian Cancer Special Section.
Accessed July 2019 via ACS website.
3American Cancer Society. Survival Rates for Ovarian
Cancer. Accessed July 2019 via ACS
website.
Precigen Media Contact:
Donelle M. Gregory
press@precigen.com
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SOURCE Precigen, Inc.