Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), through its
wholly-owned subsidiary Aeterna Zentaris GmbH, (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today announced
that the Company has entered into an exclusive option agreement to
evaluate a preclinical potential COVID-19 vaccine developed at the
Julius-Maximilians-University Wuerzburg (the “University”), one of
Germany’s leading research and teaching universities. The vaccine
technology developed at the University uses a typhoid fever vaccine
as a carrier strain and has the potential to be an orally active
COVID-19 (SARS-CoV-2) live-attenuated bacterial vaccine.
Under the option agreement entered into with the
University, Aeterna has the right to negotiate an exclusive
worldwide license to develop this technology for the prevention of
coronavirus diseases, including COVID-19. A scientific advice
meeting with the German authorities at Paul-Ehrlich Institute has
been scheduled by the University to discuss a roadmap towards
initiating a first-in-human clinical trial. Aeterna believes that,
if it is determined that there is sufficient data to advance into
human clinical trials, the development program for this particular
COVID-19 vaccine is expected to be abbreviated because extensive
clinical safety data is already available for the underlying
vaccine strain, Salmonella Typhi Ty21a. Aeterna expects to make a
decision whether to exercise its option to negotiate a license for
that technology by mid 2021.
“While vaccines for COVID-19 have been
developed, we believe there is opportunity for improvement. That
includes the potential to develop a more cost-effective oral
alternative with less onerous storage requirements than the
currently approved COVID-19 vaccines,” commented Dr. Klaus Paulini,
Chief Executive Officer of Aeterna Zentaris. “We are optimistic
that results from further studies of this new vaccination approach
may offer a much needed, safe and effective immunization
alternative against COVID-19. Aeterna will contribute its expertise
and experience in preclinical development and GMP-compliant
manufacturing to the project.”
Prof. Thomas Rudel of the University added: “Our
new vaccine technology based on the live-attenuated Salmonella
Typhi Ty21a strain modified to present two viral antigens, opens
the opportunity for a new oral vaccination strategy which may have
the potential to prevent people from infection with SARS-CoV-2. In
addition, the use of dual antigens in one vaccine strain, may lower
the likelihood of evolution of resistant viral mutants. We believe
that a positive decision by Aeterna Zentaris to license this
technology will start a fruitful collaboration with Aeterna, with
the aim to begin the clinical development as soon as possible.”
About the University’s Potential
COVID-19 Vaccine
The technology underlying the new vaccine
approach is based on the bacterium Salmonella Typhi Ty21a which has
been engineered to express and secrete two coronavirus antigens
fused to an immunological adjuvant peptide. The plasmid-maintenance
system is free of antibiotic resistance genes. The specific
bacterial vector strain enables oral application and release of the
proteins into the gut system which will consequently via M-cells
stimulate mucosal and systemic immunity.
The Salmonella Typhi Ty21a carrier strain has
been safely used worldwide in more than 150 million administered
doses. Some of those existing vaccine products have been shown to
be stable at fridge temperature of 2°C to 8°C. While the use and
characteristics of the University’s COVID-19 vaccine candidate
remain to be demonstrated through further preclinical and clinical
studies, the goal is to develop an oral dosage form COVID-19
vaccine that can be stored in a common fridge or at room
temperature.
About COVID-19
COVID-19 is the disease caused by a new
coronavirus called SARS-CoV-2, and was first reported in December
2019 in Wuhan, Hubei province, China. Most people infected with the
COVID-19 virus will experience mild to moderate respiratory illness
and recover without requiring special treatment. Older people,
and those with underlying medical problems like cardiovascular
disease, diabetes, chronic respiratory disease, and cancer are more
likely to develop serious illness.
Globally over 102 million cases and over 2.2
million deaths are reported since the start of the pandemic.
Currently, there are no definite approved therapies endorsed by the
World Health Organization for COVID-19, focusing only on supportive
care and preventive immunization.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
macimorelin, is the first and only U.S. FDA and European Commission
approved oral test indicated for the diagnosis of adult growth
hormone deficiency (AGHD). Macimorelin is currently marketed in the
United States under the tradename Macrilen™ through a license
agreement with Novo Nordisk where Aeterna receives royalties on net
sales. According to a commercialization and supply agreement,
MegaPharm Ltd. will seek regulatory approval and then commercialize
macimorelin in Israel and the Palestinian Authority. Additionally,
upon receipt of pricing and reimbursement approvals, Aeterna
expects that macimorelin will be marketed in Europe and the United
Kingdom through a recently established license agreement with
Consilient Health Ltd. and Aeterna will receive royalties on net
sales and other potential payments.
Aeterna is also 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.
Aeterna is actively pursuing business
development opportunities for the commercialization of macimorelin
in Asia and the rest of the world, in addition to other
non-strategic assets to monetize their value. 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 forward-looking
statements (as defined by applicable securities legislation) made
pursuant to the safe-harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
include those relating the potential of the University’s
coronavirus vaccine platform technology (and any vaccine candidates
using that technology) to be effective as a vaccine against
COVID-19 (SARS-CoV-2) or any other coronavirus disease (or to offer
an alternative to other approved vaccines against COVID-19, the
ability to obtain approval to commence any clinical trial or the
timeline to develop any potential vaccine, the characteristics of
any potential vaccine (including cost, storage temperatures and
oral availability) and the ability of the Company to negotiate a
mutually agreeable license agreement with the University, those
relating to the Company obtaining approval of macimorelin for CGHD,
the Company’s ability to secure marketing partners for macimorelin
in other key markets, the timing of the commencement of the CGHD
Study P02, and may include, but are not limited to statements
preceded by, followed by, or that include the words "will,"
"expects," "believes," "intends," "would," "could," "may,"
"anticipates," "potential" and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known and unknown risks and uncertainties, including those
discussed in this press release and in our Annual Report on Form
20-F, under the caption "Key Information - Risk Factors" filed with
the relevant Canadian securities regulatory authorities in lieu of
an annual information form and with the U.S. Securities and
Exchange Commission. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, that the University’s coronavirus vaccine platform
technology (and any vaccine candidates using that technology) has
never been tested in humans and so further pre-clinical or clinical
studies of that technology and any vaccine developed using that
technology may not be effective as a vaccine against COVID-19
(SARS-CoV-2) or any other coronavirus disease, that such technology
or vaccines may not receive the necessary approvals to be studied
in human clinical trials, that the timeline to develop a vaccine
may be longer than expected, that such technology or vaccines may
not be capable of being used orally, may not have the same
characteristics (including storage temperatures) as vaccines
previously approved using the Salmonella Typhi Ty21a carrier
strain, any such vaccine developed using the University’s
technology may not lower the evolution of resistant viral mutants
or may not be competitive with vaccines developed by third parties
against COVID-19, and that the Company may not be successful in
negotiating a license to such technology from the University if the
Company elects to exercise its option to negotiate, our ability to
raise capital and obtain financing to continue our currently
planned operations, our ability to continue to list our Common
Shares on the NASDAQ, 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 with Novo Nordisk, the global
instability due to the global pandemic of COVID-19, and its unknown
potential effect on our planned operations, including studies, our
ability to enter into out-licensing, development, manufacturing,
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect, our reliance on third
parties for the manufacturing and commercialization of Macrilen™
(macimorelin), potential disputes with third parties, leading to
delays in or termination of the manufacturing, development,
out-licensing or commercialization of our product candidates, or
resulting in significant litigation or arbitration, uncertainties
related to the regulatory process, unforeseen global instability,
including the instability due to the global pandemic of the novel
coronavirus, our ability to efficiently commercialize or
out-license Macrilen™ (macimorelin), our reliance on the success of
the pediatric clinical trial in the European Union (“EU”) and U.S.
for Macrilen™ (macimorelin), the degree of market acceptance of
Macrilen™ (macimorelin), our ability to obtain necessary approvals
from the relevant regulatory authorities to enable us to use the
desired brand names for our product, our ability to successfully
negotiate pricing and reimbursement in key markets in the EU for
macimorelin, any evaluation of potential strategic alternatives to
maximize potential future growth and shareholder value may not
result in any such alternative being pursued, and even if pursued,
may not result in the anticipated benefits, our ability to take
advantage of business opportunities in the pharmaceutical industry,
our ability to protect our intellectual property, and the potential
of liability arising from shareholder lawsuits and general changes
in economic conditions. Investors should consult our quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties. Given these
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.
Investor Contact: Jenene Thomas JTC Team T
(US): +1 (833) 475-8247 E: aezs@jtcir.com
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