Zalgen awarded CEPI contract to supply test kits for largest Lassa Fever study in West Africa

Sierra Leone Telegraph: 30 August 2021:

Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on preparedness for high impact, neglected infectious diseases including Lassa Fever (LF), has announced its contract with the Coalition for Epidemic Preparedness Innovations (CEPI) to further advance the development of vaccines against Lassa Fever (LF) in West Africa, a region where the disease is endemic.

Zalgen, whose mantra is preparedness and whose mission is to develop countermeasures for existing and emerging hemorrhagic fevers that could become pandemics, is able to support CEPI and aligns to CEPI’s mission through its goal to create a world in which epidemics are no longer a threat.

Under the terms of the contract, Zalgen will supply its LF antibody testing kits (ReLASV® Pan-Lassa NP IgG ELISA kits) to CEPI’s Enable study partners in Benin, Guinea, Liberia, Nigeria, and Sierra Leone, over a three-year period, to test up to 7,000 participants for LF antibodies (specifically, anti-LASV nucleoprotein (NP) human IgG antibodies).

Enable is the largest ever LF study, created and funded by CEPI, to provide a more accurate assessment of the incidence of infections in West Africa, as the true case count is unknown and may differ from current estimates of 100,000 to 300,000 cases per year.

Tracking LF antibodies using Zalgen’s testing kits will better guide estimates of how many individuals in the general population are likely to have previously been infected with the virus. Data provided through the use of Zalgen’s test kits, and the broader Enable Lassa research program seeks to better understand the rate, location, and spread of Lassa virus (LASV) across the region, while also informing the location and implementation of future late-stage trials of Lassa vaccines.

CEPI is a leading funder of Lassa vaccine development, with six Lassa vaccine candidates in preclinical and Phase 1 trials currently in its portfolio. CEPI’s goal, as part of its $3.5B lookahead strategy launched in March 2021, is to produce a licensed Lassa vaccine for routine immunization.

LASV, a potentially deadly hemorrhagic illness, is a Category A pathogen and a Biosafety Level 4 (BSL-4) agent according to the US National Institutes of Allergy and Infectious Diseases (NIAID) and the US Centers for Disease Control (CDC).

The World Health Organization (WHO), classifies LASV as one of the pathogens with epidemic potential, thereby making the development of safe and effective vaccines a top global health priority.

“Zalgen was founded on the concept of developing solutions to emerging viral threats in neglected regions of the world”, said Managing Director and Co-Founder of Zalgen Labs, Luis M. Branco, Ph.D.

“We intend to continue to work with CEPI and our other partners and collaborators worldwide to address Lassa Fever and to prepare for other unmet needs yet to surface.”

Zalgen has developed and commercializes an extensive group of research diagnostic test products for Lassa virus, Ebola virus and other tropical viral diseases, including assays to be performed in centralized testing sites and rapid diagnostic tests to be used in field testing.

“We are delighted to be working with Zalgen Labs to use their Lassa antibody tests as part of our Enable Lassa research programme,” said CEPI’s Director of Vaccine Research & Development Dr. Melanie Saville.

“Used across five partner countries who have experienced outbreaks of the potentially deadly haemorrhagic fever, these kits will provide novel information to help support healthcare workers and researchers in West Africa on the true disease burden, while also providing the critical data necessary for future late-stage Lassa vaccine clinical trials.”

As part of CEPI’s access commitments, data from the Enable Lassa research program will be made available to partners and the public via peer-reviewed open-access publications and via CEPI’s hub on The Global Health Network.

Further information on Lassa fever and CEPI’s Lassa vaccine candidates can be found in the ‘Lassa fever Disease Factfile’ on the CEPI website. More information about the Enable study is provided in CEPI’s launch and follow-up announcements.

About Zalgen Labs – Germantown, Maryland

Zalgen Labs LLC is a leading biotechnology and diagnostics company with headquarters in Germantown, Maryland, and an advanced diagnostic product development center in Aurora, Colorado. The company specializes in the design and production of superior biological molecules critical for the development and commercialization of immunotherapeutics, novel vaccines, and reliable, rapid, and affordable diagnostic platforms targeting neglected and underrepresented human viral infectious diseases including Ebola virus (EBOV) and Lassa virus (LASV).

Zalgen’s focus is on preparedness and its mission is to develop countermeasures for existing and emerging hemorrhagic fevers that could become pandemics. Zalgen technology and products strengthen global capabilities in biosafety, biosecurity, and readiness for pathogen outbreaks and support medical countermeasure efforts directed to pandemic diseases and major epidemic-prone diseases. See Zalgen.com. Follow us on Twitter and LinkedIn.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development.

CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X). During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms previously developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations.

The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX. CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens.

The plan is available at endpandemics.cepi.net.

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