Three European biotech companies agreed to collaborate on the development and large-scale manufacture of a novel adenoviral vector-based vaccine against COVID-19. The vaccine candidate is expected to enter clinical trials during summer 2020 with large-scale vaccine production planned to start soon after.
Officials at ReiThera, Leukocare, and Univercells say they will bring together expertise in vector-based vaccine development, vaccine formulation, and manufacturing, respectively, to accelerate the development of the vaccine. The companies have formed a pan-European consortium to pursue this strategy and develop a single-dose vaccine.
The partners are targeting the spike protein of SARS-CoV-2. The vaccine technology is based on a ReiThera proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans, explains Stefano Colloca, chief technology officer. Vaccines based on simian adenoviral vectors have been evaluated in Phase I and II clinical trials and proved to be safe and immunogenic, he adds. ReiThera is preparing for a COVID-19 first-in-human trial to be started in Italy in summer 2020.
In parallel to its clinical development, the consortium will start manufacturing and stockpiling the vaccine. With these pilot-scale processes, approximately 6 million doses of the vaccine are expected to be available early in 2021. Based on the Phase I/II clinical results and a path agreed with regulatory authorities, the intention will be to vaccinate the most exposed people such as medical and healthcare professionals and highly vulnerable individuals.
Leukocare is contributing to the project by developing a liquid vaccine formulation based on its technology platform for formulations of viruses and viral vectors. Univercells will capitalize on previous work with its scale-X™ bioreactor and NevoLine™ biomanufacturing platform to adapt and scale up the technology platform and enable the mass production of ReiThera’s vaccine candidate, notes José Castillo, chief technology officer of Univercells.
“By combining the experience of the partners, the advanced stages of this vaccine development will allow for a swift response to the COVID-19 pandemic,” predicts Michael Scholl, CEO, Leukocare.