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 exercised its option announced on February 2, 2021
and has entered into an exclusive worldwide sub-licensable patent
and know-how license agreement for a potential COVID-19 vaccine
currently in preclinical development that was invented at the
Julius-Maximilians-University Wuerzburg (the “University”), one of
Germany’s leading research and teaching universities. Additionally,
the Company has entered into a research agreement with the
University to conduct supplementary research activities and
preclinical development studies on the potential vaccine.
The vaccine technology developed at the
University uses the approved typhoid fever vaccine Salmonella Typhi
Ty21a as a carrier strain and has the potential to be an orally
active, live-attenuated bacterial vaccine to prevent SARS-CoV-2
infection leading to COVID-19.
“Over the last months, we learned that the
original SARS-CoV-2 strain mutates rapidly, and these mutant
strains continue to spread throughout the population. It has been
reported that the currently available vaccines for COVID-19 are
still effective against the known mutant strains. However, we
believe there is the potential to develop an improved vaccine which
relies on several SARS-CoV-2 antigens in parallel with the goal of
improving the immune response against mutated viruses.
Additionally, our vaccine has the potential to become a
cost-effective oral alternative with less demanding storage and
logistics requirements”, commented Dr. Klaus Paulini, Chief
Executive Officer of Aeterna Zentaris. “We look forward to
advancing our scientific collaboration with Prof. Rudel and his
group at the University. Aeterna plans to select from a set of
vaccine candidates to perform further in vitro and in vivo
characterization before selecting the most active and stable
bacterial strain for further preclinical and potentially clinical
development. The goal is to develop an oral dosage form of COVID-19
vaccine which is also active against mutated viruses that can be
stored in a common fridge and manufactured with relatively low
costs of goods.
Prof. Thomas Rudel of the University added, “We
are looking forward to our collaboration with Aeterna and a new
phase of accelerated preclinical and potential clinical
development. Our oral vaccine candidates based on the Salmonella
Typhi Ty21a vaccine platform technology open the possibility to
integrate more than one SARS-CoV-2 related antigen into the
expression system of the modified vaccine bacteria and may improve
the immune response of an individual against mutated viruses.”
About the Potential COVID-19
Vaccine
The approved Salmonella Typhi Ty21a bacterial
strain is the basis of the new vaccine approach against corona
virus infections. The typhoid fever vaccine Ty21a is effective,
safe, easy to handle, and the capsule formulation can be stored at
fridge temperature of 2°C to 8°C. The most common vaccine capsule
Vivotif® has been used worldwide in more than 150 million
administered doses.
The carrier strain has been modified by plasmid
insertion with two expression cassettes together with a special E.
coli-based secretion system to secrete two or more coronavirus
antigens fused to an immunological adjuvant peptide. Additionally,
a balanced lethal system based on an essential tRNA synthetase has
been integrated to stabilize the plasmid in the absence of
antibiotic resistance genes. The specific bacterial vector strain
is expected to enable oral application and release of the proteins
into the gut system which may consequently stimulate mucosal and
systemic immunity.
Transaction Terms and
Conditions
On March 14, 2021, the Company exercised the
Option and entered into the License Agreement. Pursuant to the
terms of the License Agreement, the Company has been granted an
exclusive, world-wide, license to certain patents and know-how
owned by the University to research and develop, manufacture, and
sell a potential COVID-19 vaccine using the University’s bacterial
vaccine platform technology (the “Licensed Rights”). The Company
will pay an up-front payment under the License Agreement of
€140,000 as well as make certain milestones payments to be paid
upon the achievement of certain development, and regulatory and
sales milestones as well as a percentage of any sub-licensing
revenue received by the Company and royalty payments on net sales
of the licensed vaccine products (including for by the Company or
its sub-licensees). The License Agreement will expire upon the
latter of (i) the existence of a valid patent claim of a Licensed
Right or (ii) 10 years after the first commercial sale of a product
that was developed, manufactured, marketed, and sold using a least
one Licensed Right. The License Agreement may be terminated by the
Company by providing six (6) months’ notice to the University.
Pursuant to the License Agreement, the
University has also granted the Company an exclusive option for the
exclusive use of the Licensed Rights in an undisclosed field. The
Company has six (6) months from the date of the License Agreement
to exercise that is option.
Additionally, the Company has entered into the
Research Agreement under which the Company has engaged the
University on a fee-for-service basis to conduct supplementary
research activities and preclinical development studies on the
potential vaccine.
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 116 million confirmed cases and
over 2.5 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 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 in
this press release include those relating to 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 and
the characteristics of any potential vaccine (including cost,
storage temperatures and oral availability and Aeterna’s
expectation that, upon receipt of pricing and reimbursement
approvals, macimorelin will be marketed in Europe and the United
Kingdom and the initiation of Study P02, which is expected to be
initiated in Q2 of 2021. 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, 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 (“E.U.”) 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 E.U. for
Macrilen™ (macimorelin), the outcome of our pre-clinical and
clinical development efforts of in-licensed products, 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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