Batavia Biosciences announces today that they have successfully produced vaccine material for a Phase I clinical trial of IAVI’s Lassa fever vaccine candidate, rVSV∆G-LASV-GPC. The vaccine candidate was manufactured using Batavia’s highly intensified vaccine manufacturing platform (HIP-Vax^®). This platform uses the novel fixed-bed bioreactor, scale-X™, enabling the use of high cell densities during manufacturing.

IAVI’s Lassa fever vaccine candidate, rVSV∆G-LASV-GPC, uses a recombinant vesicular stomatitis virus (rVSV) vector — the same rVSV platform used for the rVSV-vectored Ebola Zaire vaccine, ERVEBO^®, a highly efficacious vaccine licensed by Merck, which is now registered for use in eight African countries.

Based on promising preclinical efficacy data generated by IAVI, the funder of this multi-year, multifaceted program, the Coalition for Epidemic Preparedness Innovations (CEPI), has given the green light to move the vaccine into clinical testing. A Phase I clinical trial of IAVI’s Lassa fever vaccine candidate is being conducted by a network of clinical research centers in the US and Africa.

Chris Yallop, Ph.D., COO at Batavia Biosciences, states: “The combination of scale-X bioreactors and Batavia’s HIP-Vax^® process technology enables the production of high volumes of vaccine doses in a small footprint facility, dramatically reducing capital and operational costs and facilitating supply. It is therefore very well suited to produce global health and epidemic preparedness vaccines such as for Lassa fever.”

Swati Gupta, Head of Emerging Infectious Diseases and Scientific Strategy at IAVI, adds: “We continue to be excited about our close partnership with Batavia Biosciences for the production of recombinant VSV vaccines using their transformative HIP-Vax technology.  Through an innovative partnership model among Batavia Biosciences, CEPI, and an expert global consortium of collaborators, we plan to further develop and test the rVSV∆G-LASV-GPC vaccine candidate. Together with our partners, we are committed to making a Lassa fever vaccine accessible to all populations who need it, should the vaccine candidate be found safe and effective in clinical testing.”

Menzo Havenga, Ph.D., CEO at Batavia Biosciences, concludes: “This is a major step in the validation of Batavia’s HIP-Vax^® platform, designed to ensure low-cost manufacture of global health and stockpile vaccines to counter epidemics. Therefore, it supports our mission to reduce human suffering from infectious diseases.”