Pan-European consortium established to rapidly develop vaccine
A pan-European consortium of biotech companies announced April 23 that they will collaborate to develop and manufacture on a large scale a novel adenoviral vector-based vaccine against COVID-19.
The vaccine candidate is expected to enter clinical trials mid 2020 with vaccine production planned to start following the successful trials. If all goes according to plan, approximately 6 million doses of the vaccine are expected to be available early in 2021.
The consortium comprises Italian company ReiThera, German LEUKOCARE, and Belgian Univercells. They provide expertise in vector-based vaccine development, vaccine formulation and manufacturing, respectively. Their combined expertise is expected to enable efficient and ultra-fast vaccine development.
The vaccine technology is based on a novel, ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans. Vaccines based on simian adenoviral vectors have been extensively evaluated in Phase 1 and 2 clinical trials and proved to be safe and immunogenic. ReiThera is currently preparing for a COVID-19 first-in-human trial to be started in Italy in mid 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 1/2 clinical results and a path agreed with regulatory authorities, the intention with these doses will be to vaccinate the most exposed people such as medical and healthcare professionals and highly vulnerable individuals.
LEUKOCARE will contribute to the drug product development by developing a highly stable liquid vaccine formulation based on its well-established technology platform for formulations of viruses and viral vectors.
Univercells will take advantage of the previous successes of 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.
Michael Scholl, Chief Executive Officer of LEUKOCARE, commented: “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. Facing the current challenges, our approach for the fast and low-risk development of drug products with superior stability characteristics is even more important regarding timelines and social impact.”