Type: Oral coronavirus vaccine designed to target mucosal cells
Status: Stabilitech said June 12 it agreed to partner with another New Zealand company, BioCell, to manufacture OraPro-COVID-19. The value of the partnership was not disclosed. Stabilitech cited BioCell’s 30 years’ experience in manufacturing viral vaccines, and its dedicated premises for the manufacturing of COVID-19 vaccines as a result of its recent acquisition of Living Cell Technology’s GMP compliant cell culture facility.
Human trials for OraPro-COVID-19 are set for August. If successful, the vaccine could be on the market by the end of 2020 as a result of the partnership.
In April, Stabilitech said it was seeking an investment of £6 million (about $7.5 million) to fund clinical trials and manufacturing of OraPro-COVID-19 capsules. While InnovateUK has requested that Stabilitech repurpose funding it received toward a Zika therapeutic to start R&D of OraPro-COVID-19, the company said a larger investment is required to finance its next stage of development.
To generate protective immunity, the Spike-protein DNA from COVID-19 or “S-protein cargo” is inserted into a non-replicating adenovirus, the viral vector. The viral vector delivers the S-protein cargo DNA to mucosal intestinal cells, which produce copies of the COVID-19 S-protein, resulting in mucosal and systemic immunity. It takes two to three weeks for the immunity to develop. OraPro’s thermal stability technology is applied and packaged within an acid resistant capsule designed to protect the vaccine as it passes through the stomach before being dissolved in the gut.
Because it is thermally stable, the vaccine is unharmed by the high temperatures in the stomach. Stabilitech’s OraPro-COVID-19 capsules contain a freeze-dried COVID-19 vaccine and are designed to not need refrigeration, enabling mailing and self-administration: “Once it has been delivered via post, you can simply swallow the capsule,” Stabilitech chairman Wayne Channon said in a statement.
Stabilitech said it has concluded initial animal safety trials. The next stage of development is clinical trials overseen by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Trials are set to start in June, with the vaccine available possibly by year’s end, the company said.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: