Full Press Release Details
Zentaris Announces Exclusive License Agreement and Research Contract with Julius-Maximilians-University Wuerzburg
for Development of a Potential Oral Prophylactic Bacterial Vaccine Against COVID-19
Company secures next step to continue to build-out pipeline of assets
Company exercised its option to enter into an exclusive license of intellectual property for the development of a proprietary
and orally active bacterial vaccine platform technology currently undergoing pre-clinical studies for the prevention of coronavirus
diseases, including COVID-19
S.C., March 15, 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 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.
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
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.
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."
the Potential COVID-19 Vaccine
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
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.
Terms and Conditions
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.
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.
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.
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 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.
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 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