GERMANTOWN, Md., March 12,
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 that Cantor Fitzgerald will
be hosting a virtual fireside chat with Precigen on
Monday, March 25, 2024 at
1:00 PM ET to discuss the
investigational PRGN-2012
AdenoVerse™ immunotherapy for the treatment
of recurrent respiratory papillomatosis (RRP). The event will be
hosted by Jennifer Kim,
Biotechnology Analyst at Cantor Fitzgerald, and participants will
include Helen Sabzevari,
PhD, President and CEO of Precigen, and Clint T. Allen, MD, Principal Investigator,
Section on Translational Tumor Immunology at the National
Institutes of Health (NIH), and a lead investigator for the
PRGN-2012 clinical study.
Event details can be found on Precigen's website in the Events
& Presentations section at
investors.precigen.com/events-presentations.
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.
About RRP
RRP is a rare,
difficult-to-treat and sometimes fatal neoplastic disease of the
upper and lower respiratory tracts that is caused by infection with
HPV 6 or HPV 11.1-4 RRP is classified based on age of
onset as juvenile or adult. Currently, there is no cure for RRP and
the current standard-of-care is repeated endoscopic debulking with
ablation or excision of papillomatous lesions.3,4
Recurrence of papilloma after surgical removal is very common and
repeated procedures are required to debulk and monitor the disease,
which exposes patients to anesthetic and surgical risks, and
emotional distress. RRP morbidity and mortality results from the
effects of papilloma mass on the vocal cords, trachea, and lungs,
which may cause voice changes, stridor, airway occlusion, loss of
lung volume, and/or post-obstructive pneumonia.5
Although rare, one to three percent of RRP cases can transform into
invasive squamous cell carcinoma.6,7
About PRGN-2012 AdenoVerse™
Immunotherapy
PRGN-2012 AdenoVerse immunotherapy is an
innovative therapeutic vaccine with optimized antigen design that
uses gorilla adenovector technology, part
of Precigen's proprietary AdenoVerse platform, to
elicit immune responses directed against cells infected with HPV 6
or HPV 11. Gorilla adenovectors have numerous advantages, including
the ability for repeat administration, the inability to
replicate in vivo, and the ability to deliver a large
genetic payload. PRGN-2012 is currently under investigation in
a Phase 1/2 pivotal single-arm study in adult patients
with RRP in the United States (clinical trial
identifier: NCT04724980). PRGN-2012 has been
granted Orphan Drug Designation and Breakthrough Therapy
Designation in patients with RRP by the FDA and Orphan Drug
Designation by the European Commission.
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 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.
AdenoVerse™ Immunotherapy
Clinical Program
Precigen's AdenoVerse immunotherapy
platform is currently under clinical investigation in a Phase 1/2
study of PRGN-2009 AdenoVerse immunotherapy alone or in combination
with an anti-PDL1/TGF-Beta Trap in patients with HPV-associated
cancers (NCT04432597), a Phase 2 study of PRGN-2009 in combination
with pembrolizumab in newly diagnosed patients with
HPV-associated oropharyngeal squamous cell carcinoma
(OPSCC) (NCT05996523), a Phase 2 study of PRGN-2009 AdenoVerse
immunotherapy in combination with pembrolizumab in patients with
recurrent or metastatic cervical cancer
(NCT06157151), and a Phase 1/2 study of PRGN-2012
AdenoVerse immunotherapy in patients with recurrent respiratory
papillomatosis (RRP) (NCT04724980).
Trademarks
Precigen, AdenoVerse, UltraVector 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
References
1 Mounts, P et al. (1982).
"Viral etiology of juvenile- and adult-onset squamous papilloma of
the larynx." Proc Natl Acad Sci U S A 79(17): 5425-5429.
2 Smith, E et al. (1993). "Human papillomavirus
infection in papillomas and nondiseased respiratory sites of
patients with recurrent respiratory papillomatosis using the
polymerase chain reaction." Arch Otolaryngol Head Neck Surg 119(5):
554-557.
3 Derkay, CS et al. (2008). "Recurrent respiratory
papillomatosis: a review." Laryngoscope 118(7): 1236-1247.
4 Derkay, CS et al. (2019). "Update on Recurrent
Respiratory Papillomatosis." Otolaryngol Clin North Am 52(4):
669-679.
5 Seedat, RY (2020). "Juvenile-Onset Recurrent
Respiratory Papillomatosis Diagnosis and Management - A Developing
Country Review." Pediatric Health Med Ther 11: 39-46.
6 Dedo, HH et al. (2001). "CO(2) laser treatment in
244 patients with respiratory papillomas." Laryngoscope 111(9):
1639-1644.
7 Silver, RD et al. (2003). "Diagnosis and
management of pulmonary metastasis from recurrent respiratory
papillomatosis." Otolaryngol Head Neck Surg 129(6): 622-629.
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SOURCE Precigen, Inc.