Aeterna Zentaris, through its wholly-owned subsidiary Aeterna Zentaris, 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, one of Germany’s 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.
Under 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.
“While 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,” said 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.”
The 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.
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The 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 temperature.
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 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.