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Aeterna Zentaris announces the expansion of its research program

Rresearch agreement extended for development of 3D models of human intestinal tissues to study the pathogenesis of Salmonella enterica

TORONTO, ONTARIO, March 10, 2022 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company that develops and commercializes a diversified portfolio of pharmaceutical and diagnostic products, today announced that it expanded the scope of its existing research program with Julius-Maximilians-University Wuerzburg (“JMU”), on the development of COVID-19 and Chlamydia yourachomatis vaccines. Expanded research activities will take advantage of JMU’s program involving three-dimensional models (“3D models”) of human intestinal tissue to study the biology of infection in the intestine, the site of Salmonella primary action. The Company expects this approach to generate additional, more relevant and predictive data for the regulatory process, while reducing the number of costly and time-consuming animal experiments.

Aeterna’s innovative vaccine technology aims to induce mucosal immunity for potential infection prevention and is designed to use two antigens for enhanced protection against pathogen escape mutants, both of which are considered advantageous characteristics over current vaccines.

“As coordinator of the German Research Foundation-funded Graduate College 3D Infect, Professor Rudel’s experience speaks for itself, and we believe it will be a tremendous asset to our efforts. He is already involved in the Inno4vac project supported by the European Innovative Medicines Initiative 2, focused on the design and application of advanced predictive human models for vaccine development,” commented Dr. Klaus Paulini, Chief Executive Officer of ‘Aeterna Zentaris. “We are very pleased to expand our scientific collaboration with Professor Rudel and his group at JMU.”

Professor Dr Thomas Rudel of JMU, added: “Salmonella Typhi, the carrier strain of the vaccine platform used in the Aeterna vaccine program, is an obligatorily pathogenic bacterium for humans, which is taken up by specific mucosal cells of the human gastrointestinal tract. Direct contact with mucosa-associated lymphoid tissue (MALT) induces a strong immune response. The great specificity of our Salmonella The Typhi vaccine strain Ty21a for human tissues limits validation in complex intestinal tissues in animal models.

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In March 2021, Aeterna entered into an exclusive license agreement pursuant to which the Company obtained an exclusive worldwide license to certain patent applications and know-how belonging to JMU for the research and development, manufacture and sale of a potential vaccine against COVID-19. The Company’s vaccine platform is currently undergoing preclinical studies for the prevention of coronavirus diseases, including COVID-19 (SARS-CoV-2).

In September 2021, the Company exercised its option under the agreement with the JMU on a second indication, Chlamydia. Chlamydia trachomatis is a sexually transmitted bacterium that infects more than 130 million people each year. The asymptomatic disease can spread to the reproductive tract, eventually resulting in infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Eye infections can lead to inclusion conjunctivitis or trachoma, which is the main source of visual impairment or infectious blindness.

In addition, the Company has entered into a research agreement pursuant to which it has engaged JMU on a fee-for-service basis to conduct additional research activities and preclinical development studies on potential vaccines, the results of which are covered under the licensing agreement. As part of the expanded research program announced today, JMU will validate and use innovative 3D human intestinal tissue models to study the biology of infection of Salmonella strains to clinical development.

Additionally, Professor Dr. Thomas Rudel of JMU was engaged by the company in September 2021 as a scientific consultant to support the development of the salmonella-based coronavirus vaccine platform and Chlamydia.

About SalmonellaBased vaccine platform

The technology underlying the new vaccine approach is based on the bacteria Salmonella Typhi Ty21a which has been engineered to express and secrete up to two coronaviruses or Chlamydia yourachomatis antigens fused to immunological adjuvant peptides. The plasmid maintenance system is thought to be free of antibiotic resistance genes. The specific bacterial vector strain is designed to allow oral application and release of the proteins into the intestinal system which, via M cells, will stimulate mucosal and systemic immunity. the Salmonella The Typhi Ty21a carrier strain has been used safely worldwide in more than 150 million administered doses of other vaccine products. Some of these existing vaccine products have been shown to be stable at a refrigerator temperature of 2°C to 8°C. Although the use and characteristics of Aeterna’s vaccine candidates remain to be demonstrated through further preclinical and clinical studies, the goal is to develop vaccines capable of inducing effective mucosal immunity to prevent infection.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company that develops and markets a diverse portfolio of pharmaceutical and diagnostic products focused on areas of high unmet medical need. The Company’s lead product, macimorelin (Macrilen), is the first and only oral test approved by the US FDA and the European Commission indicated for the diagnosis of Adult Growth Hormone Deficiency (AGHD). The Company is building on the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood 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 preclinical pipeline to potentially address unmet medical needs in 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, 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 United States and Canadian securities laws and regulations and such statements are made pursuant to the safe harbor provision of the United States Securities Litigation Reform Act of 1995. are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “potential”, “possible”, “designed”, “aims and similar expressions. Such statements, based on management’s current expectations, inherently involve numerous known and unknown risks, uncertainties and assumptions, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those regarding: Aeterna’s expectations regarding Aeterna’s COVID-19 potential and Chlamydia Trachomatis vaccination program to achieve a particular outcome, including the potential of 3D models to generate additional data that is more relevant and predictive for the regulatory process while reducing the number of costly and time-consuming animal experiments, the potential of vaccines to induce mucosal immunity and prevent protection against COVID-19 or Chlamydia Trachomatis (including escape mutants and the characteristics and potential of these vaccines.

Forward-looking statements involve known and unknown risks and uncertainties and other factors that 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 forward-looking information. These risks and uncertainties include, among others, COVID-19 and Chlamydia The Trachomatis vaccine platform technology (and any candidate vaccine using this technology) licensed from the University of Wuerzburg has never been tested in humans and therefore further preclinical or clinical studies of this technology and any vaccine developed using this technology may not be effective as a vaccine against COVID-19 (or any other coronavirus disease) or Chlamydia Trachomatis; the timeline for developing a vaccine may be longer than expected; this technology or these vaccines may not be able to be used orally or stored at refrigerated temperatures, may not have the same characteristics as previously approved vaccines using the Salmonella carrier strain Typhi Ty21a; vaccines in development may not succeed or advance the product into human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now strong dependence on the success of Macrilène (macimorelin) and related license agreements 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, Novo’s Amended License Agreement); global instability due to the global COVID-19 pandemic and geopolitical events (including the war in Ukraine), and its unknown potential effect on our planned operations; our ability to enter into licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and to maintain such agreements in effect; and our ability to continue to list our common stock on NASDAQ. Investors should consult our quarterly and annual filings with securities commissions in Canada and the United States for additional information on risks and uncertainties, including the risks discussed in our Annual Report on Form 40-F and our Annual Information Form, under the heading “Risk Factors”. Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We undertake no obligation to update these factors or to publicly announce any revision to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by a government authority or applicable law. required.

No securities regulatory authority has approved or disapproved of the contents of this press release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release.

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