#ORPH Open Orphan plc – Positive in vitro results for FLU-v published

Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that positive data from a peer-reviewed study evaluating the in vitro efficacy of FLU-v, Imutex Limited’s (“Imutex”) broad spectrum influenza vaccine, has been published in the scientific journal Vaccines.¹

Previous clinical studies have demonstrated that FLU-v induced increased antibody and cellular responses in vivo. This placebo-controlled study evaluated the ability of FLU-v to induce cellular effector functions and cross-reactivity (both measures of the immune response, with cross-reactivity being particularly important for protection against multiple viral strains) of immune cells extracted from participants, following exposure to five different influenza strains.

The study found that measurements of IFN-γ and granzyme B production in stimulated immune cells from participants that had been previously vaccinated with either FLU-v or placebo, were significantly higher in the FLU-v group both when stimulated with vaccine antigen and also with antigens from a panel of seasonal and pandemic inactivated influenza A and B strains. These results further support the continued development of FLU-v as a broad-spectrum influenza vaccine.

FLU-v is owned by Imutex, a joint venture between hVIVO and PepTcell Limited (the legal name of SEEK Group), to develop vaccines against influenza and mosquito borne diseases such as Zika virus, malaria and other flaviviruses.

Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “It is encouraging to see further positive data for FLU-v, supporting its continued development as a broad-spectrum influenza vaccine. There is a large unmet need for a broad-spectrum vaccine to help battle emerging seasonal and pandemic influenza A and B viruses. Although FLU-v had already produced successful Phase II clinical data, this in vitro study is particularly important as it showed the ability of the candidate to induce an immune response against a diverse variety of influenza A and B strains.”

^1. Oftung, F.; Næss, L.M.; Laake, I.; Stoloff, G.; Pleguezuelos, O. FLU-v, a Broad-Spectrum Influenza Vaccine, Induces Cross-Reactive Cellular Immune Responses in Humans Measured by Dual IFN-γ and Granzyme B ELISpot Assay. Vaccines 2022, 10, 1528. https://doi.org/10.3390/vaccines10091528  

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