Frontier Ip Regulatory News (FIPP)

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AIM: FIPP

05 December 2022

Frontier IP Group Plc

("Frontier IP" or the "Group")

Portfolio news - The Vaccine Group successfully completes DARPA-funded transmissible Lassa fever project

Frontier IP, a specialist in commercialising intellectual property, is delighted to note the following announcement that portfolio company The Vaccine Group ("TVG" or the "Company") has successfully completed a project to develop a transmissible vaccine for use in the rats that spread Lassa fever to reduce its threat to humans.

A small-scale trial of a candidate vaccine in controlled conditions has shown the vaccine can be transmitted between rats, significantly improve their immunity to the disease and reduce its spread between them. Technology with the potential to scale up the vaccine for commercial production was also developed as part of the project.

The work was funded by the US Defense Advanced Research Projects Agency ("DARPA") and involved TVG collaborating with academic partners from around the world. It was led by University of California, Davis ("UC Davis").

TVG is developing vaccines based on safe forms of cytomegaloviruses (CMV), members of the herpesvirus family. The project identified and isolated a strain of CMV unique to the rats for use as a vaccine vector. Antigens to the Lassa fever virus were then inserted into the CMV to create the candidate vaccine. This spread between the rats, carried by the CMV vector. The project partners also created a computer model to predict the impact of Lassa fever control interventions.

Other herpesvirus-based vaccines TVG is developing include those to combat COVID-19, African swine fever, Streptococcus suis, a disease in pigs that can cause meningitis in humans, and Porcine reproductive and respiratory syndrome virus, in collaboration with ECO Animal Health Group plc and The Pirbright Institute.

Neil Crabb, Frontier IP Chief Executive Officer, said: "The success of this project provides strong vindication for TVG's herpesvirus-based vaccine technology. Transmissible vaccines have the potential to tackle a range of zoonotic threats emerging in wild animal reservoirs, and we are looking forward to seeing further progress on Lassa fever. "

The Vaccine Group statement begins:

TVG successfully completes DARPA-funded transmissible Lassa fever vaccine project

Most emerging infectious diseases affecting humans in the last century originated in animal reservoirs and are defined as zoonotic. Lassa fever is a significant zoonotic disease threat to human health in eight West African countries with between an estimated 100,000 to 300,000 cases of disease each year, of which about 5,000 are fatal1.

The reservoir of the Lassa fever virus that causes the disease is a specific rodent population, the mastomys or multimammate rat. In collaboration with global academic partners, TVG recently came to the end of a successful project, led by UC Davis, California and funded by DARPA, to develop a transmissible vaccine to prevent Lassa fever virus circulation in the mastomys rat wildlife reservoir.

The project started in April 2019 and had three objectives:

- To understand the virus ecology in wild mastomys rat populations in W Africa, especially cytomegaloviruses (CMV) and Lassa fever virus

- To create a computer model to use as a tool to predict the outcome of Lassa Fever control interventions in wild mastomys rats

- To develop a transmissible vaccine for use in wild mastomys rat populations for the control of Lassa fever circulation and to reduce the risk of human spillover.

All objectives were completed successfully. It was shown that Lassa fever virus is circulating in mastomys rat populations in West Africa and a species-specific CMV was isolated and shown to be widespread in these populations.

The isolated CMV strains have been down-selected based upon growth parameters in vitro, and a candidate vector strain selected for use as a viral vector for the vaccine candidate. Two potentially protective antigens were identified from Lassa Fever virus, and their respective genes codon optimised and inserted into two locations in the CMV vector.

A lead candidate was selected with a transgene inserted into a single site in the CMV vaccine vector. In addition, a continuous cell line with the potential for commercial scale production of the vaccine was developed from mastomys rat tissues.

A small-scale trial batch of the candidate vaccine was used in controlled studies under Category 4 Biosecurity and was shown to be immunogenic in inoculated animals and transmissible to naïve co-housed cagemates.

Most recently the vaccine was shown to reduce Lassa fever virus infection and excretion after challenge at highly significant levels. In addition, the vaccine is constructed to achieve the necessary level of Lassa virus immunity before gradually losing the Lassa virus gene, which restores the vaccine to naturally occurring wild type CMV already present in animals.

Future work will use the vaccine challenge study data to refine the computer model developed to predict the outcomes of Lassa fever control interventions. Next steps will include further controlled vaccine transmission and efficacy studies, technical transfer of the vaccine production system to a manufacturing partner for scale-up and pilot field studies in Lassa Fever virus-endemic regions.

Continued engagement with stakeholders with an interest in the control of Lassa fever in W Africa will be important to identify the environment in which the tools developed by this project can be deployed.

Jeremy Salt, TVG Chief Executive Officer, said: "This is a highly successful project that has delivered a range of tools that can be taken forward as part of a control programme for Lassa fever in West Africa. From a standing start in 2019 the global project team has pooled resources to enable the development of a candidate vaccine developed from a cytomegalovirus strain that was not even available before the project began. The team has created a thorough understanding of the viral ecology in the mastomys rat population in the region where Lassa fever is endemic. Combining this data has led to an informed computer model for assessment of intervention strategies to aid in the control of this important zoonotic viral pathogen in West Africa."

1US Centers for Disease Control and Prevention: https://www.cdc.gov/vhf/lassa/index.html

The Vaccine Group statement ends

ENQUIRIES

ABOUT THE VACCINE GROUP

The Vaccine Group, a spin out from the University of Plymouth, is developing vaccines based on benign forms of herpesviruses. These are a group of viruses found in all animals, including humans.

The Company is targeting two main areas: zoonotic diseases, which jump from animals to humans, and economically damaging diseases in livestock. The COVID-19 vaccine is the first of the company's vaccines being developed for humans.

The Company and its international partners have so far been backed by more than £9 million in grant funding from the US, UK and Chinese governments. The US government is funding development of Ebola and Lassa fever virus vaccines. The company has also signed its first commercial agreement to develop vaccines for Porcine Respiratory and Reproductive Virus Syndrome with ECO Animal Health Group plc.

Other projects underway include developing a vaccine against Streptococcus suis, a disease in pigs which can be fatal in humans and can only currently be treated with large doses of antibiotics.

For more information: www.thevaccinegroup.com

ABOUT FRONTIER IP

Frontier IP unites science and commerce by identifying strong intellectual property and accelerating its development through a range of commercialisation services. A critical part of the Group's work is involving relevant industry partners at an early stage of development to ensure technology meets real world demands and needs.

The Group looks to build and grow a portfolio of equity stakes and licence income by taking an active involvement in spin-out companies, including support for fund raising and collaboration with relevant industry partners at an early stage of development.

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