Detalimogene voraplasmid is a novel,
investigational, pivotal-stage, non-viral genetic medicine designed
to mitigate systemic risks and deliver durable efficacy for
patients with high-risk NMIBC, including Bacillus Calmette-Guérin
(BCG)-unresponsive disease
Ongoing, pivotal, registrational LEGEND study
is actively enrolling patients with sites participating in the USA,
Canada, Europe and the Asia-Pacific region
enGene’s Dually Derivatized Oligochitosan®
(DDX) platform is designed to potentially overcome the limitations
of viral gene therapies and increase patient and clinician access
to therapies
enGene Holdings Inc. (Nasdaq: ENGN, or “enGene” or the
“Company”), a clinical-stage genetic medicines company whose
non-viral lead investigational product detalimogene voraplasmid
(also known as detalimogene, and previously EG-70) is in an ongoing
pivotal study in patients with high-risk, Bacillus Calmette-Guérin
(BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with
carcinoma in situ (CIS), today announced three poster presentations
at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) to be
held February 13-15, 2025 in San Francisco.
“Patients with NMIBC often face a debilitating, multi-year
journey with limited treatment options and significant negative
impacts to daily life. These patients are most commonly treated by
community urologists who face unique challenges accessing and
providing optimal care, including global treatment shortages and
complex usage and handling,” said Ron Cooper, Chief Executive
Officer of enGene. “We are determined to develop genetic therapies
for underserved conditions like NMIBC and ultimately provide a long
overdue treatment innovation designed to advance care and ease the
treatment burden.”
There are an estimated 730,000 patients in the U.S. living with
bladder cancer, and approximately 75% to 80% of all bladder cancer
diagnoses are NMIBC. Among patients diagnosed with high-risk NMIBC,
more than half (50-70%) will become BCG-unresponsive and experience
recurrence and/or progression after treatment.
“The current treatment options for patients with high-risk NMIBC
are sadly sub-optimal, often resulting in disease progression,
recurrence or removal of the bladder as a life-altering measure of
last resort,” said Anthony Cheung, Chief Scientific Officer and
Co-Founder of enGene. “If approved, we believe detalimogene
voraplasmid will be uniquely compelling to both patients and
physicians by combining a streamlined administration process
designed to ease the treatment experience with durable efficacy and
a favorable safety and tolerability profile.”
Presentation details are outlined below:
Preliminary results from LEGEND: A phase 2 study of
detalimogene voraplasmid (EG-70), a novel, non-viral intravesical
gene therapy for patients with BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC) with carcinoma in situ (CIS)
- Abstract #: 802
- Poster #: F29
- Clinical Trial Registration Number: NCT04752722
- Session Title: Poster Session B: Urothelial
Carcinoma
- Presentation Date/Time: Friday, February 14 from
11:30am-12:45pm PT
- Location: Level 1, West Hall
- Presenting Author: John Taylor III, MD, MS, Professor of
Urology & Cancer Biology, University of Kansas Cancer
Center
Mechanism of action and translation to the clinic of
detalimogene voraplasmid (EG-70): A novel, investigational,
non-viral immunotherapy for non-muscle-invasive bladder cancer
(NMIBC)
- Abstract #: 826
- Poster #: G22
- Clinical Trial Registration Number: NCT04752722
- Session Title: Poster Session B: Urothelial
Carcinoma
- Presentation Date/Time: Friday, February 14 from
11:30am-12:45pm PT
- Location: Level 1, West Hall
- Presenting Author: Vikram Narayan, MD, Assistant
Professor in the Department of Urology at Emory University School
of Medicine
A phase 1/2 study of detalimogene voraplasmid (EG-70)
intravesical monotherapy for patients with high-risk non-muscle
invasive bladder cancer (NMIBC)
- Abstract #: TPS886
- Poster #: J14
- Clinical Trial Registration Number: NCT04752722
- Session Title: Trials In Progress Poster Session B:
Urothelial Carcinoma
- Presentation Date/Time: Friday, February 14 from
11:30am-12:45pm PT
- Location: Level 1, West Hall
- Presenter: Shreyas Joshi, MD, MPH, Assistant Professor
in the Department of Urology at Emory University School of
Medicine
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease with a
significant patient burden, high clinical needs and massive
economic impact on our healthcare system. NMIBC occurs when cancer
cells grow in the tissues that line the interior of the bladder,
but the cancer has not yet penetrated deeper into the muscle of the
bladder wall. About 75-80% of new bladder cancer diagnoses are
NMIBC. Patients suffering from high-risk NMIBC who are unresponsive
to the standard of care, Bacillus Calmette-Guérin (BCG), face high
rates of disease recurrence (50-70%) and are subject to full
removal of the bladder (cystectomy) as a curative but life-altering
next step.
About Detalimogene Voraplasmid
Detalimogene voraplasmid (formerly known as EG-70) is a novel,
investigational, non-viral genetic medicine for patients with
high-risk, non-muscle invasive bladder cancer (NMIBC), including
Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed
to be instilled in the bladder and elicit a powerful yet localized
anti-tumor immune response.
Detalimogene voraplasmid has received Fast Track designation
from the U.S. Food and Drug Administration (FDA) based on its
potential to address a high unmet medical need for patients with
BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without
resected papillary tumors who are unable to undergo cystectomy.
Fast Track designation is a process designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need.
Detalimogene was developed using the Company’s Dually
Derivatized Oligochitosan® (DDX) platform, a technology designed to
transform how gene therapies are accessed by patients and utilized
by clinicians. Medicines developed with the DDX platform can
potentially overcome the limitations of viral-based gene therapies,
simplify safe handling and cold storage complexities and streamline
both manufacturing processes and administration paradigms.
About the Pivotal LEGEND Trial
Detalimogene voraplasmid is being evaluated in the ongoing,
open-label, multi-cohort, Phase 2 LEGEND trial to establish its
safety and efficacy in high-risk, non-muscle invasive bladder
cancer (NMIBC). LEGEND’s pivotal cohort (Cohort 1) consists of
approximately 100 patients with high-risk, Bacillus Calmette-Guérin
(BCG)-unresponsive NMIBC with carcinoma in situ (CIS) (with or
without papillary disease) and is designed to serve as the basis of
the Company’s Biologics License Application (BLA) filing. In
addition to this pivotal cohort, three additional cohorts are
actively enrolling patients, including NMIBC patients with CIS who
are naïve to treatment with BCG (Cohort 2a); NMIBC patients with
CIS who have been exposed to BCG, but have not received adequate
BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC
patients with papillary-only disease (Cohort 3).
The LEGEND trial is actively enrolling patients with sites
participating in the USA, Canada, Europe and the Asia-Pacific
region. For more information, please visit TheLegendStudy.com.
About enGene
enGene is a clinical-stage biotechnology company mainstreaming
genetic medicines through the delivery of therapeutics to mucosal
tissues and other organs, with the goal of creating new ways to
address diseases with high clinical needs. enGene’s mission is to
deliver innovative non-viral medicines to improve the quality of
life for people with urological cancers. enGene’s lead program is
detalimogene voraplasmid for patients with non-muscle invasive
bladder cancer (NMIBC) with carcinoma in situ (CIS) – a disease
with a high clinical burden – who are unresponsive or naïve to
treatment with Bacillus Calmette-Guérin (BCG).
To learn more, please visit enGene.com and follow us on
LinkedIn.
Forward-Looking Statements
Certain statements contained in this press release may
constitute “forward-looking statements” within the meaning of the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, and “forward-looking information” within the meaning
of Canadian securities laws (collectively, “forward-looking
statements”). enGene’s forward-looking statements include, but are
not limited to, statements regarding enGene’s management teams’
expectations, hopes, beliefs, intentions, goals or strategies
regarding the future. In addition, any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. The words “anticipate”, “appear”,
“approximate”, “believe”, “continue”, “could”, “estimate”,
“expect”, “foresee”, “intends”, “may”, “might”, “plan”, “possible”,
“potential”, “predict”, “project”, “seek”, “should”, “would”, and
similar expressions (or the negative version of such words or
expressions) may identify forward-looking statements, but the
absence of these words does not mean that a statement is not
forward-looking. Forward-looking statements may include, for
example, statements about: our beliefs as to the potential benefits
of detalimogene, including its potential to provide a highly
differentiated treatment option, if approved, and the potential
benefits of medicines developed with the DDX platform.
Many factors, risks, uncertainties and assumptions could cause
the Company’s actual results, performance or achievements to differ
materially from those expressed or implied by the forward-looking
statements, including, without limitation, the Company’s ability to
recruit and retain qualified scientific and management personnel,
establish clinical trial sites and enroll patients in its clinical
trials, execute on the Company’s clinical development plans and
ability to secure regulatory approval on anticipated timelines, and
other risks and uncertainties detailed in filings with Canadian
securities regulators on SEDAR+ and with the U.S. Securities and
Exchange Commission (“SEC”) on EDGAR, including those described in
the “Risk Factors” section of the Company’s Annual Report on Form
10-K for the fiscal year ended October 31, 2024 (copies of which
may be obtained at www.sedarplus.ca or www.sec.gov).
You should not place undue reliance on any forward-looking
statements, which speak only as of the date on which they are made.
enGene anticipates that subsequent events and developments will
cause enGene’s assessments to change. While enGene may elect to
update these forward-looking statements at some point in the
future, enGene specifically disclaims any obligation to do so,
unless required by applicable law. Nothing in this press release
should be regarded as a representation by any person that the
forward-looking statements set forth herein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved.
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Media Contact: Green Room Communications 908-577-4531
mediainquiries@grcomms.com Investor Contact:
investors@engene.com
enGene (NASDAQ:ENGN)
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