December 4, 2020

Batavia Biosciences and KU Leuven join forces to accelerate development of highly promising COVID-19 vaccine candidate

Leiden, 3 December 2020 – KU Leuven, a leading research institution and one of the top 50 universities in the world and Batavia Biosciences, a contract development and manufacturing organization focused on delivering sustainable manufacturing solutions in the field of vaccines and oncology, today announce their partnership on the development of a vector based COVID-19 vaccine candidate.

The virology team at the KU Leuven Rega Institute for Medical Research, headed by Prof Dr Johan Neyts, has developed a SARS-CoV-2 vaccine candidate consisting of an attenuated vector carrying the SARS-CoV-2 spike immunogen. The vector is derived from the live-attenuated yellow fever vaccine (YF17D strain), which is a proven safe and effective vaccine, used worldwide to protect more than 500 million people against yellow fever.

The YF17D-SARS-CoV-2 vaccine candidate, tentatively named RegaVax, shows convincing pre-clinical immunogenicity and efficacy data in challenge studies, as recently published in Nature (Sanchez-Felipe et al., 2020). Based on this promising data the research group is now confident to start the next phase of development, heading towards preparation for clinical trials.

To support this activity, KU Leuven has partnered with Batavia Biosciences BV, a frontrunner in developing highly intensified and low-cost vaccine manufacturing processes. Batavia will leverage its vaccine development and manufacturing experience together with its high intensity HIP-Vax® manufacturing technology to develop a clinical manufacturing process for the vaccine candidate, deliver clinical product and prepare for large-scale commercial supply.

Prof Neyts (Head of the Virology research group at the KU Leuven Rega Institute) commented: “RegaVax is the only COVID-19 vaccine candidate based on the yellow fever vaccine. In preclinical models, for example with hamsters, one single dose appears to be highly efficient in protecting against infection with SARS-CoV-2. We hope that this vaccine, will, like the yellow fever vaccine on which it is based, provide, after a single dose, long-lasting protection against this coronavirus.”

Dr. Menzo Havenga (CEO, Batavia Biosciences) stated: “We are delighted to team up with the group of Prof Neyts as the preclinical data generated by the team at KU Leuven for this vaccine candidate look extremely promising.” Dr Christopher Yallop (COO, Batavia Biosciences) added: “Our HIP-Vax® technology is ideally suited to develop and manufacture this vaccine rapidly and cost effectively and we are very much looking forward to work closely with the KU Leuven team to deliver the clinical product and help move this vaccine candidate to licensure.”

The partnership aims to deliver the clinical product and to commence clinical testing in 2021.

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