Dr. Klaus Paulini reports

AETERNA ZENTARIS ANNOUNCES EXPANSION OF RESEARCH PROGRAM WITH JULIUS-MAXIMILIANS-UNIVERSITY WUERZBURG AIMING TO ACCELERATE DEVELOPMENT OF VACCINE PROGRAMS

Aeterna Zentaris Inc. has expanded the scope of its existing research program with the Julius-Maximilians-University Wuerzburg (JMU) on the development of COVID-19 and chlamydia trachomatis vaccines. The expanded research activities will leverage JMU's program involving three-dimensional models of human intestinal tissues to study infection biology in the gut, the site of salmonella primary action. The company expects this approach to generate more relevant and predictive additional 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 the potential prevention of infections and is designed to use two antigens for better protection against escape mutants of the pathogens, both believed to be advantageous features when compared with current vaccines.

"As co-ordinator of the Graduate College '3-D Infect,' funded by the German Research Foundation, Prof. Rudel's experience speaks for itself, and we believe that 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 the development of vaccines," commented Dr. Klaus Paulini, chief executive officer of Aeterna Zentaris. "We are very pleased to broaden our scientific collaboration with Prof. Rudel and his group at JMU."

Prof. Thomas Rudel of JMU added:: "Salmonella typhi, the vaccine platform carrier strain used in the Aeterna vaccine program, is an obligatory human-pathogenic bacterium, which is taken up by specific mucosal cells of the human gastrointestinal tract. Direct contact to the mucosa-associated-lymphoid-tissue (MALT) induces a strong immune response. The high specificity of our salmonella typhi Ty21a vaccine strain for human tissue limits a validation in the complex intestinal tissues of animal models."

Background

In March, 2021, Aeterna entered into an exclusive licence agreement where the company was granted an exclusive worldwide licence to certain patent applications and know-how owned by JMU to research and develop, manufacture, and sell a potential COVID-19 vaccine. 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 infecting over 130 million people annually. Asymptomatic disease can spread to the reproductive tract, eventually inducing infertility, miscarriage or ectopic pregnancy, which is a life-threatening condition. Ocular infections can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness.

Additionally, the company entered into a research agreement under which it has engaged JMU on a fee-for-service basis to conduct supplementary research activities and preclinical development studies on the potential vaccines, the results of which are covered within the scope of the licence agreements. Under the expanded research program announced today, JMU will validate and utilize innovative human 3-D intestinal tissue models to study the infection biology of salmonella strains toward clinical development.

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

About the salmonella-based vaccine platform

The technology underlying the new vaccine approach is based on the bacterium salmonella typhi Ty21a, which has been engineered to express and secrete up to two coronavirus or chlamydia trachomatis antigens fused to immunological adjuvant peptides. The plasmid-maintenance system is believed to be free of antibiotic resistance genes. The specific bacterial vector strain is designed to enable 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 of other vaccine products. Some of those existing vaccine products have been shown to be stable at fridge temperature of two degrees Celsius to eight degrees Celsius. While 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 which can induce mucosal immunity efficiently preventing infection.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The company's lead product, macimorelin (Macrilen), is the first and only U.S. Food and Drug Administration and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The company is 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, 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 across 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.

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