One of Germany’s leading research and teaching universities, Julius-Maximilians-University Wuerzburg (the University) recently announced that a potential COVID-19 vaccine developed there was optioned by a publicly traded biopharmaceutical company originally founded in Canada. Aeterna Zentaris just entered into an exclusive worldwide sub-licensable patent and know-how license agreement for the vaccine candidate as well as a research agreement with the University to conduct supplementary research activities and preclinical development studies on the potential vaccine. The company is paying an upfront license fee of €140,000 ($166,464) and has agreed to targeted milestone payments based on achieved development, regulatory and sales targets. Additionally, a percentage of any sub-licensing revenue received by the Company will go to the University plus royalty payments on net sales of licensed vaccine products—to either Company or any of its sub-licensees. The vaccine candidate not only would be designed to better take on SARS-CoV-2 variants, but would also be more convenient, orally administered with easier storage and logistics requirements.
What is the vaccine candidate?
The 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 to COVID-19.
The 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.
What are some attributes that make the existing vaccine attractive for purposes of leveraging for COVID-19?
The approved Salmonella Typhi Ty21a bacterial strain is the basis of the new vaccine approach against coronavirus 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 administered doses.
When asked about the rationale for this deal Dr. Klaus Paullino, CEO of the company, declared, “Over 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.”
What are the next steps?
The University and biotech will collaborate and conduct a series of in vitro and in vivo characterization prior to selecting what the CEO of the company reports would be “the most active and stable bacterial strain for further preclinical and potentially clinical development.”
What is the goal of the collaboration?
Develop a robust vaccine with high effective rates against all SARS-CoV-2 variants that can be administered orally, and is easily stored and shipped lowering overall costs.
One of the oldest institutions of higher learning in Germany, this center was founded in 1402. A public research university located in Wurzburg, the university is part of the U15 group of research-intensive Germany universities, as well as the Coimbra Group.
Aeterna 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. For a company structure, follow the link.
A microcap stock, the company’s low stock price of 1.38 leaves a market capitalization of $159.47 million on little revenue and losses reported at about $7 million.