Oral presentation highlights rational design
of EG-70 to address challenges faced by other intravesical
treatment options, including preparation, handling, and safety
considerations
BOSTON and MONTREAL, May 2, 2024
/CNW/ - enGene Holdings Inc. (Nasdaq: ENGN) or ("enGene" or
the "Company"), a clinical-stage genetic medicines company whose
non-viral lead program EG-70 is in a pivotal study for
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today
announced an oral presentation at the American Urology Association
(AUA) 2024 Annual Meeting being held May
3-6, 2024 in San Antonio,
Texas.
The presentation, "LEGEND: a Phase 1/2 study of EG-70
(detalimogene voraplasmid), a novel, non-viral intravesical gene
therapy for patients with BCG-unresponsive non-muscle invasive
bladder cancer with carcinoma in situ (CIS)," will be given by Dr.
Gordon Brown, Director of the Center
for Advanced Therapeutics and Urologic Oncology, Summit
Health-South, at 10:30 a.m. CT on
Friday, May 3rd during the Paradigm-shifting,
Practice-changing Clinical Trials in Urology Plenary Session. The
complete dataset from the 12-month follow-up of all patients in the
Phase 1 portion of LEGEND will be reported at a future meeting or
within a peer-reviewed publication.
"I am pleased to present a detailed overview of EG-70 and the
pivotal Phase 1/2 LEGEND study. EG-70 is designed to be a
practice-changing product that does not require a change in
practice for urologists, offering attributes that render it
practical for use in community-based and high-volume clinics." said
Dr. Brown.
Dr. Richard Bryce, enGene's Chief
Medical Officer, added: "The promising initial efficacy and safety
data from LEGEND's Phase 1 cohort in high-risk, BCG-unresponsive
NMIBC patients with CIS, combined with its ease of handling,
simplicity of administration, minimal storage requirements, and
lack of post-procedural patient restrictions, demonstrate EG-70's
potential to unlock the power of genetic medicine for any and all
urologists."
"EG-70 was rationally designed to be easy to use and meet the
needs of patients and urologists alike. As a non-viral,
non-infectious, locally delivered genetic medicine, EG-70 is
designed to synergistically activate both the innate and adaptive
immune responses, be easily reconstituted in water, and require
only a short procedural time," said Jason
Hanson, Chief Executive Officer of enGene. "Within the
subgroup of patients in LEGEND's Phase 1 who received our optimized
Phase 2 dose, we saw complete response rates of 70% and 60% at
three months and six months, respectively, which speak to EG-70's
potential to drive durable remissions. The encouraging safety data
from the Phase 1 study also suggest that this efficacy was achieved
without significant impairment to the patients' quality of life. We
look forward to providing additional updates on the broader EG-70
program as we look to expand its potential use across bladder
cancer."
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 lead program is
EG-70 for patients with non-muscle invasive bladder cancer (NMIBC)
with carcinoma in situ (Cis) who are unresponsive or naïve to
treatment with Bacillus Calmette-Guérin (BCG) – a disease with a
high clinical burden. EG-70 is being evaluated in an ongoing Phase
2 pivotal study. EG-70 was developed using enGene's proprietary
Dually Derivatized Oligochitosan (DDX) platform, which enables
penetration of mucosal tissues and delivery of a wide range of
sizes and types of cargo, including DNA and various forms of RNA.
For more information, visit enGene.com.
Forward-Looking
Statements
Some of the 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 expectations, hopes,
beliefs, intentions, goals, strategies, forecasts and projections.
The words "anticipate", "appear", "approximate", "believe",
"continue", "could", "estimate", "expect", "foresee", "intend",
"may", "might", "plan", "possible", "potential", "predict",
"project", "seek", "should", "would", and similar 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 EG-70.
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, 2023 and most
recent Quarterly Report on Form 10-Q (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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SOURCE enGene Inc.