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Aeterna Zentaris Announces Evaluation and Potential Development of an Oral Prophylactic Bacterial Vaccine Against COVID-19 Through Exclusive Option Agreement with Julius-Maximilians-University Wuerzburg - Company secures

Key Takeaway: Zentaris Announces Evaluation and Potential Development of an Oral Prophylactic Bacterial Vaccine Against COVID-19 Through Exclusive Option Agreement with Julius-Maximilians-University Wuerzburg Company secures next step to continue to build-out pipeline of assets University r

Full Press Release Details

Zentaris Announces Evaluation and Potential Development of an Oral Prophylactic Bacterial Vaccine Against COVID-19 Through Exclusive
Option Agreement with Julius-Maximilians-University Wuerzburg
Company secures next step to continue to build-out pipeline of assets
University researchers developed a proprietary and orally active bacterial vaccine platform technology currently undergoing pre-clinical
studies for the prevention of coronavirus diseases, including COVID-19
Aeterna Zentaris to evaluate the University's coronavirus vaccine platform technology including COVID-19 under an exclusive
S.C., February 2, 2021 - 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.
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.
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."
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."
the University's Potential COVID-19 Vaccine
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.
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
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.
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.
Aeterna Zentaris Inc.
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.
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.
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.
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
Last updated: Feb 2, 2021