hVIVO's Imutex publishes Phase I results for mosquito vaccine candidate
( ) (formerly Open Oprhan), a specialist contract research organisation, announced publication of positive data from a first-in-human Phase 1 clinical study evaluating the safety and immunogenicity of a mosquito vaccine candidate.
The vaccine candidate is AGS-v PLUS, owned by Imutex, a joint venture with PepTcell Limited (the parent company of ConserV Bioscience), in which hVIVO has a 49% interest.
AGS-v PLUS is a vaccine candidate against arboviral diseases that targets the saliva of the mosquito rather than the pathogens carried by the mosquito. It has a novel proposed dual-action mechanism of preventing infection in humans while controlling the mosquito population through affecting reproduction.
The data has been published in eBioMedicine, a peer-reviewed open access biomedical journal part of The Lancet Discovery Science. The published manuscript shows data from the study conducted at the University of Maryland School of Medicine and sponsored by NIAID-NIH, demonstrating that all AGS-v PLUS formulations evaluated were well-tolerated with no serious adverse events experienced, and that they generated a robust cellular and humoral immune response in participants.
Additionally, the immune response mounted against AGS-v PLUS was shown to reduce infectivity of Zika virus in vitro.
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A positive set of results from Imutex's AGS-v PLUS mosquito vaccine candidate has now been published in a leading peer-reviewed journal. The first-in-human Phase 1 trial showed that the candidate was well-tolerated and generated a strong immune response in participants without serious side effects.
hVIVO said the next steps would be to determine if the findings translate into clinical efficacy against mosquito-borne diseases, such as Zika, West Nile, chikungunya, dengue, yellow fever, and malari, which inflict a severe burden on public health systems around the world. There are an estimated c. 360 million cases and 600,000 deaths from mosquito-borne diseases annually, although the actual figure is likely higher. An effective vaccine against multiple mosquito-borne diseases would be a major breakthrough.
More and more pharma and biotech companies are trusting hVIVO's model as they learn about the benefits of human challenge trials. Four of the top ten global biopharma companies are now regular clients of hVIVO. Not only is the company's number of clients increasing, but the size of contracts is growing as well.
This growth is being driven by increasing demand for human challenge services in a rapidly expanding infectious and respiratory disease clinical trials market. Since the Covid-19 pandemic, there has been a marked increase in the number of companies looking to test vaccines and antivirals against specific subtypes of viruses that have the potential to be widely spread.
Human challenge studies can provide great value for biotech and pharma companies as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 studies. This gives companies the best possible chance of quickly advancing their candidates through the development pathway.
hVIVO's long string of major contracts signed this year speaks to the rapid momentum the company has generated in only 9 months, with the pace continuing to accelerate. The company's book order nearly tripled to £70m in 1H22 to 30 June 2022. In July and August alone, hVIVO recorded £9m of new revenue and added £4.1m to its cash balance. Last month's RSV contract added another £13.6m to hVIVO's order book and is expected to generate significant revenues in 2023 and 2024. Another £80+ million of orders are also expected to be recognised across 2022, 2023, and 2024, giving investors much to look forward to.
Imutex is 49%-owned by hVIVO, with the other 51% owned by PepTcell Limited.
hVIVO is well-capitalised and on track to meet market expectations for FY22.
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