Accelerate biotechnology

Batavia successfully uses innovative HIP-Vax to manufacture IAVI’s Lassa fever vaccine candidate for Phase I clinical trials

Leiden, The Netherlands, July 14, 2021 – 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.”

About Lassa fever

Lassa virus is an emerging zoonotic virus that can cause a range of symptoms in humans, including hemorrhage, vomiting, swelling of the face, bleeding, and pain in the chest, back, and abdomen. The Lassa virus is most commonly transmitted to humans from an infected rodent known as the multimammate rat (Mastomys natalensis). However, the virus can also spread from person to person via bodily fluids.

An estimated 300,000 to 500,000 Lassa fever cases are diagnosed annually, resulting in approximately 5,000 deaths. However, the true disease burden is currently unknown, and efforts are ongoing to provide a more accurate estimate of the incidence of the deadly haemorrhagic disease. Despite recurrent outbreaks, no vaccine for Lassa fever is currently available. In addition to its toll in affected countries in Africa, Lassa fever has the potential to spread more widely if infected individuals travel and become ill outside the endemic region. The WHO has identified Lassa fever as one of the top emerging pathogens likely to cause severe outbreaks in the near future in its Research and Development Blueprint for Action to Prevent Epidemics.

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