Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company developing and
commercializing a diversified portfolio of pharmaceutical and
diagnostic products, today announced that results from pre-clinical
studies of Aeterna’s AIM Biologicals (Autoimmunity Modifying
Biologicals) for the potential treatment of neuromyelitis optica
spectrum disorder (“NMOSD”) were accepted for presentation at the
13th International Congress on Autoimmunity to be held June 10-13,
2022 in Athens, Greece.
The accepted abstract was selected for a poster
presentation and an oral presentation at the Congress, which will
be given by Aeterna’s research collaborator, Valentin Bruttel, PhD,
Senior Researcher, Department of Obstetrics and Gynecology, School
of Medicine, University of Wuerzburg (“the University”). Details of
the abstract and presentations are as follows:
Title: Antigen presentation on
MHC class Ib-related molecules induces Aquaporin4-specific
regulatory T cells in PBMC from NMOSD patients and prevents
experimental autoimmune encephalomyelitis in mice
Poster Presentation
Date and time: Poster will be displayed during the whole
congress
Location: Exhibit space, Megaron Athens
International Conference Centre, (MAICC), Athens, Greece
Oral Presentation
Track: Parallel Session 12 - CNS - Central
Nervous System (ID 25)Date and time: Sunday, June 12, 2022, at
12:10 – 12:20
Location: Room “Nikos Skalkatos”, Megaron Athens
International Conference Centre (MAICC), Athens, Greece
The abstract can be accessed under the following
link:https://cslide.ctimeetingtech.com/auto22/attendee/confcal/show/session/25
“We are pleased that this abstract has been
accepted for presentation at such a prestigious auto-immunity
conference, considered to be the largest multidisciplinary congress
that discusses all aspects of auto-immunity diseases, and which
attracts some of the world’s most distinguished experts in
auto-immunity”, commented Dr. Klaus Paulini, Chief Executive
Officer of Aeterna. “In collaboration with Aeterna, Dr. Bruttel,
Prof. Dr. Wischhusen, and our combined teams continue their efforts
to explore the utility of AIM Biologicals for the treatment of
NMOSD. In this abstract they will present, for the first time, some
proof-of concept of AIM Biological in both in vitro and mouse
models.”
Dr. Bruttel of the University, added, "These
studies demonstrate that the AIM Biologicals induce human
AQP4-specific regulatory T cells in vitro and prevent
neuroinflammatory disease in animal models. We believe that
Aquaporin-4-specific AIM Biologicals may be suitable for targeted
immunosuppression in neuromyelitis optica spectrum disorders and
are looking forward to continuing our work with our exclusive
licensee, Aeterna, to advance this further.”
About Neuromyelitis Optica Spectrum Disorder
(NMOSD)
NMOSD is an antibody mediated inflammatory
central nervous system ("CNS") disorder that affects about one per
million population per year. NMOSD, also known as Devic’s disease,
is a chronic disorder of the brain and spinal cord dominated by
inflammation of the optic nerve (optic neuritis) and of the spinal
cord (myelitis). Typical symptoms include visual loss, muscle
spasms, paraparesis, and incontinence. If left untreated, 50% of
individuals with NMOSD will become wheelchair bound and blind, and
30% will have died within five years after the first attack. The
water channel protein AQP4 is widely expressed in the brain, spinal
cord, and optic nerves. Auto-antibodies directed against AQP4 play
an important role in the pathogenesis of NMOSD.
Currently there are only three approved
medications available for the treatment of NMOSD, all with very
high annual treatment costs and the risk of the patient contracting
serious infections. Therefore, the Company believes there remains a
strong medical need to offer new therapeutic options to the
patients.
In the U.S. and Europe there are currently
approximately 10,000 to 15,000 patients living with NMOSD. Of these
the AQP4 antibody seropositive patients who represent about 80% of
the NMOSD population are the targeted patients for a potential
therapy based on the AIM Biologicals technology. About AIM
Biologicals
AIM Biologicals utilize a novel mechanism which
is believed to demonstrate that peptide antigens presented on
immunosuppressive MHC class I molecules can selectively and
efficiently induce antigen-specific tolerance. Based on this
mechanism, the targeted immunomodulating therapeutics are being
designed as optimized soluble molecules with the goal that they may
be adapted to selectively induce tolerance to various autoantigens.
Pre-clinical studies conducted by the University thus far indicate
that tolerance induction appears to be achieved via selective
elimination of antigen-specific immune effector cells and via
induction of antigen-specific regulatory T cells from naïve T
cells. AIM Biologicals thus have the potential to become highly
specific and effective yet not personalized treatments of
NMOSD.
For the treatment of NMOSD, it is believed that
the AIM Biologicals will present a specific antigen derived from
the water channel protein aquaporin-4 (AQP4) loaded to soluble
immunoregulatory HLA-G protein to selectively induce immunological
tolerance in the central nervous system.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty
biopharmaceutical company developing and commercializing a
diversified portfolio of pharmaceutical and diagnostic products
focused on areas of significant unmet medical need. The Company's
lead product, macimorelin (Macrilen™; Ghryvelin®), is the first and
only U.S. FDA and European Commission approved oral test indicated
for the diagnosis of adult growth hormone deficiency (AGHD). The
Company is leveraging the clinical success and compelling safety
profile of macimorelin to develop it for the diagnosis of
childhood-onset growth hormone deficiency (CGHD), an area of
significant unmet need, in collaboration with Novo Nordisk.
Aeterna Zentaris is dedicated to the development
of therapeutic assets and has recently taken steps to establish a
growing pre-clinical pipeline to potentially address unmet medical
needs across a number of indications, including neuromyelitis
optica spectrum disorder (NMOSD), Parkinson's disease (PD),
hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou
Gehrig's disease). Additionally, the Company is developing an oral
prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and
Chlamydia trachomatis.
For more information, please visit
www.zentaris.com and connect with the Company on Twitter, LinkedIn
and Facebook.
Forward-Looking Statements
This press release contains statements that may
constitute forward-looking statements within the meaning of U.S.
and Canadian securities legislation and regulations and such
statements are made pursuant to the safe-harbor provision of the
U.S. Securities Litigation Reform Act of 1995. Forward-looking
statements are frequently, but not always, identified by words such
as “expects,” “anticipates,” “believes,” “intends,” “potential,”
“possible,” and similar expressions. Such statements, based as they
are on current expectations of management, inherently involve
numerous risks, uncertainties and assumptions, known and unknown,
many of which are beyond our control. Forward-looking statements in
this press release include, but are not limited to, those relating
to: expectations regarding conducting pre-clinical research to
identify and characterize an AIM Biologicals-based development
candidate for the treatment of NMOSD.
Forward-looking statements involve known and
unknown risks and uncertainties, and other factors which may cause
the actual results, performance or achievements stated herein to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
information. Such risks and uncertainties include, among others,
results from ongoing or planned pre-clinical studies of our
products under development may not be successful or may not support
advancing the product to human clinical trials; our ability to
raise capital and obtain financing to continue our currently
planned operations; our now heavy dependence on the success of
Macrilen™ (macimorelin) and related out-licensing arrangements and
the continued availability of funds and resources to successfully
commercialize the product, including our heavy reliance on the
success of the license agreement and the amended license agreement
(collectively the Novo Amended License Agreement); the global
instability due to the global pandemic of COVID-19 and the war in
the Ukraine and the resulting geopolitical instability, and its
unknown potential effect on our planned operations; our ability to
enter into out-licensing, development, manufacturing, marketing and
distribution agreements with other pharmaceutical companies and
keep such agreements in effect; and our ability to continue to list
our common shares on the NASDAQ. Investors should consult our
quarterly and annual filings with the Canadian and U.S. securities
commissions for additional information on risks and uncertainties,
including those risks discussed in our Annual Report on Form 20-F
and annual information form, under the caption "Risk Factors".
Given the uncertainties and risk factors, readers are cautioned not
to place undue reliance on these forward-looking statements. We
disclaim any obligation to update any such factors or to publicly
announce any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments,
unless required to do so by a governmental authority or applicable
law.
No securities regulatory authority has either
approved or disapproved of the contents of this news release. The
Toronto Stock Exchange accepts no responsibility for the adequacy
or accuracy of this release.
Investor Contact:
Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
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