25 Aug 2021
Oslo, Norway & Germantown, Maryland, August 25, 2021 – Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on preparedness for high impact, neglected infectious diseases including Lassa Fever (LF), today 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.
Luis M. Branco, Ph.D
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.
Executive Director of Vaccine Research and Development, CEPI
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.
About Lassa fever and Lassa vaccine development
Lassa haemorrhagic fever is spread through contact with the infected rodent host Mastomys natalensis, or from person-to-person contact via bodily fluids. It is a zoonotic viral infection found predominantly in West Africa. The majority of patients who become infected with Lassa virus infection are asymptomatic; however, in some cases the disease may progress to more serious symptoms including fever, vomiting, body pains, and haemorrhaging. Death may occur within two weeks after symptom onset due to multi-organ failure. Further information on Lassa fever can be found in the ‘Lassa fever Disease Factfile’ on the CEPI website.
There are no licensed vaccines or treatments specifically for Lassa. CEPI currently has 6 Lassa vaccine candidates in its portfolio – with Emergent Biosolutions & PATH, Inovio Pharmaceuticals, IAVI, Themis Bioscience, Janssen Vaccines & University of Oxford, and CureVac. Inovio’s Lassa fever candidate entered Phase I clinical trials in May 2019. Themis initiated Phase I clinical trials of its Lassa fever vaccine candidate in October 2019. CEPI and its partner the European & Developing Countries Clinical Trials Partnership (EDCTP) recently announced additional funding for a Phase IIb trial assessing IAVI’s Lassa vaccine candidate in endemic countries. Its Phase I vaccine study launched this year.
About the Enable Lassa research programme
The Enable Lassa research programme study site partners are:
BENIN Fondation pour la Recherche Scientifique (FORS)
LIBERIA Co-led by University of North Carolina at Chapel Hill (UNC) and Phebe Hospital in partnership with the National Public Health Institute of Liberia (NPHIL)
GUINEA Université Gamal Nasser de Conakry (UGANC) in partnership with Robert Koch Institut (RKI)
NIGERIA Nigeria Centre for Disease Control (NCDC), Irrua Specialist Teaching Hospital (ISTH), Federal Medical Centre (FMC) Owo, Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA), Redeemer’s University Nigeria (RUN) and the African Field Epidemiology Network (AFENET). Together, the Nigerian partners make up the NiLE project of Enable.
SIERRA LEONE Co-led by Kenema Government Hospital (KGH) and Tulane University
A total of US $26 million in funding has been made available across the programme. CEPI works as a funder and facilitator, supporting the financing of the programme as well as supporting a country-led governance framework and forging key links to the global scientific and vaccine development communities.
In addition to the country partners, CEPI has selected four implementing partners to support the execution and oversight of the Enable programme. P-95 acts as programme coordinator, providing scientific and operational oversight to all coordinating partners and country study implementation teams as well as programme-level project management. The Margan Clinical Research Organization (MMARCRO), based in Accra, Ghana, supports P-95 through in-country field implementation and study monitoring support. Epicentre, a Paris-based organization conducting field epidemiology activities, research projects and training sessions in support of Médecins Sans Frontières (MSF); leads development of the programme data management system; is providing training and support to staff operating at Enable study sites; and is supervising the data collection, management, and analysis processes. The Bernard Nocht Institute for Tropical Medicine, based in Hamburg, Germany, supports the Enable programme through laboratory expertise and support to country implementing partners, including staff training, laboratory process development, and quality assurance.
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.
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.
B Squared on behalf of Zalgen
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