Hope for first ever Lassa fever vaccine as candidate enters Phase 1 clinical trial
*NCDC confirms five new cases from Edo, Ondo, Bauchi with no new death
There is hope for the first ever Lassa fever vaccine as Themis Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI) on Tuesday announced the first administration to healthy volunteers in a Phase 1 clinical trial with Themis’ vaccine candidate against the viral haemorrhagic fever.
The MV-LASV Lassa fever vaccine candidate is based on Themis’ proprietary measles vector platform and exclusively licensed discoveries made at Institut Pasteur.
Lassa fever is also known as Lassa haemorrhagic fever. The Lassa virus is transferred to humans via contact with food or household items that are contaminated with rat urine or feces, most commonly by the infected Mastomys rodent. The virus can spread from person-to-person via bodily fluids and causes a range of symptoms including vomiting, swelling of the face, bleeding, and pain in the chest, back and abdomen. There is currently no vaccine that protects against Lassa fever.
Interestingly, Nigeria has one of the highest cases and deaths of Lassa fever in the world. Outbreaks of Lassa fever in Nigeria used to be seasonal but have become perennial since 2017, occurring throughout the year.
Latest figures from the Nigeria Centre for Disease Control (NCDC) confirmed five new cases from Edo, Ondo and Bauchi states with no new death. According to the NCDC, from January 1 to October 13, 2019, a total of 4,099 suspected cases have been reported from 23 states and of these, 726 were confirmed positive, 19 probable and 3,354 negative. However, since the onset of the 2019 outbreak, there have been 154 deaths in confirmed cases.
The MV-LASV Lassa fever vaccine programme is funded through a global partnership with CEPI that will support the candidate vaccine’s development up to the end of Phase 2, which is designed to provide clinical safety and immunological data. The investment, which was the first in CEPI’s portfolio, will also help establish investigational stockpiles of Themis’ vaccine candidate that will be ready for clinical efficacy trial testing during outbreaks.
Managing Director (MD)/Chief Executive Officer (CEO) of Themis, Erich Tauber, in a statement, said: “Themis’ versatile technology platform and our ability to rapidly advance candidates into the clinic has been demonstrated previously through the discovery, development and production of a Phase 3-ready vaccine candidate against Chikungunya as well as our recently announced trial for a novel Zika vaccine.
“Our partnership with CEPI for Lassa fever further validates our capabilities and represents our combined commitment to tackle diseases that remain a public health threat globally.”
Director of Vaccine Development at CEPI, Dr. Melanie Saville, added: “Themis was the first company CEPI partnered with to develop a vaccine against Lassa fever and MERS, two of our priority pathogens. Lassa fever remains a serious public health threat across West Africa, with Nigeria alone experiencing its largest ever outbreak of the disease this year. This first in-human trial for Themis’ MV-LASV Lassa candidate is an important first step in its evaluation in the clinic and toward developing an effective vaccine which will be available to at-risk populations during outbreaks of this deadly emerging infectious disease.”
The MV-LASV vaccine candidate is a recombinant, live attenuated, viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection.
The Phase 1 trial with MV-LASV is a randomized, placebo-controlled, dose finding study in 60 healthy adult participants to investigate the safety, tolerability and immunogenicity of MV-LASV after administration of two different dose levels.
The study, sponsored and led by Themis, is being conducted by the Centre for the Evaluation of Vaccination in Antwerp, Belgium, under the direction of Pierre Van Damme, Professor at the University of Antwerp, Faculty of Medicine and Health Sciences.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations launched in Davos in 2017 to develop vaccines to stop future epidemics. CEPI has received multi-year funding from Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and Wellcome. CEPI has also received single-year investments from the Governments of Belgium and the United Kingdom. The European Union provides financial support for relevant projects through their Horizon 2020 programme as well as through the European and Developing Countries Clinical Trials Partnership. CEPI has reached over US$750 million of its $1 billion funding target.
Since its launch in January 2017, CEPI has announced four calls for proposals. The first call was for candidate vaccines against Lassa virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The second call was for the development of platforms that can be used for rapid vaccine development against unknown pathogens. The third call was for candidate vaccines against Chikungunya and Rift Valley fever viruses. The fourth call is for the development of platform technologies to develop vaccines and other immunoprophylactics to rapidly respond to outbreaks of unknown pathogens. To date, CEPI has committed to investing over $456 million in vaccine development. This includes 19 vaccine candidates against its priority pathogens (six against Lassa virus, five against MERS-CoV, four against Nipah virus, two against Chikungunya, two against Rift Valley fever) and three vaccine platforms to develop vaccines against Disease X. To assess the effectiveness of these platforms seven additional vaccine candidates are being developed (two against influenza, one against Marburg virus, two against Rabies virus, one against Respiratory Syncytial Virus, and one against yellow fever).
Themis is developing immunomodulation therapies for infectious diseases and cancer. Through advanced understanding of immune system mechanisms, the Company has built a sophisticated and versatile technology platform for the discovery, development and production of vaccines as well as other immune system activation approaches. Initially focused on preventing infectious diseases, Themis has demonstrated the potential of its versatile platform through the rapid and successful completion of Phase 2 and near-term entry into Phase 3 clinical development for a vaccine against Chikungunya, a debilitating disease with global outbreak potential. Funded to date by leading venture capital firms, Themis has also gained prestigious non-dilutive funding for emerging infectious disease indications.
The Company will apply its platform and commercial manufacturing capabilities to diseases with high market potential both alone and for its partners.
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