Open Orphan's (ORPH ) joint venture company, Imutex, which is currently developing a drug to combat mosquito-borne diseases, has reported some “positive data” from its Phase I clinical study. 

Imutex is a joint venture with PepTcell in which Open Orphan has a 49% shareholding.

The Phase I study of Imutex’s AGS-v PLUS asset has shown the vaccine to be well tolerated with no serious adverse events whilst generating a strong immune response in participants.

Data from the study, which was performed at the University of Maryland School of Medicine in Baltimore, demonstrated  Imutex’s AGS-v PLUS asset to show a more robust immune response compared to AGS-v, a first-generation vaccine candidate developed by Imutex.

The AGS-v PLUS vaccine contains the same four peptides as AGS-v but adds a fifth synthetic peptide found in the saliva of many mosquitoes, increasing the potential breadth of protection.

The study evaluating the effect of AGS-v PLUS on the reproductive capacity of mosquitoes that fed on vaccinated subjects found that a regimen of the vaccine in combination with an adjuvant resulted in fewer eggs laid and adult progeny in the species Aedes albopictus.

Both AGS-v PLUS and AGS-v were created by Imutex to target mosquito-borne diseases with the dual objective of preventing infection in humans whilst controlling the mosquito population.

Mosquito-borne diseases include Zika virus, West Nile virus, chikungunya virus, dengue, yellow fever, and malaria. There are around 360 million cases of and more than 600,000 deaths from mosquito-borne diseases annually, with the true burden likely underestimated.

Imutex, which is focused on developing broad-spectrum vaccines against influenza (flu) and mosquito borne diseases, said a potential life-saving vaccine that is efficacious against multiple mosquito-borne diseases like these could significantly impact public health.

The positive data from Imutex’s Phase I study will be presented this weekend in two virtual sessions at the American Society of Tropical Medicine and Hygiene Annual Meeting. Imutex then expects to publish the results from the study in a scientific peer-reviewed journal.

Cathal Friel, Executive Chairman of Open Orphan said: “If these positive Phase I results translate into clinical efficacy, the potential number of lives saved will be significant.”

Dr Olga Pleguezuelos, Chief Science Officer at PepTcell, commented: “We are very excited about the study results. AGS-v PLUS was demonstrated to be safe and immunogenic, and not only impacted the pathogenicity of the Zika virus as seen in an in vitro assay, but also reduced the number of eggs and adult progeny of mosquitoes that fed on vaccinated subjects. 

Pleguezuelos added, “The next step is to evaluate clinical efficacy in a controlled human challenge study or in a study in endemic areas. Many mosquito-borne diseases lack effective preventative and therapeutic treatments, so AGS-v PLUS could potentially save many lives.”

View from Vox

On Wednesday, Open Orphan’s hVIVO signed a £5.1m contract to test its Investigational Medicinal Product using its respiratory syncytial virus (RSV) Human Challenge Study Model. 

hVIVO, a subsidiary of the specialist contract research organisation (CRO), Open Orphan, has signed the £5.1m contract with a biopharmaceutical company that remains unnamed.

The medical laboratory division will conduct the study on behalf of its biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection. The study is due to commence in 2H22, with the revenue from the contract being recognised across 2021 and 2022, it noted.

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. 

RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults. Among the elderly (aged 65+), RSV causes as many hospitalisations and deaths as influenza, according to The Centers for Disease Control and Prevention (CDC).

Open Orphan said RSV may lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. 

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.

In August 2021, hVIVO also signed an £8.1m contract with a major global pharmaceutical firm to test its inhaled human rhinovirus (hRV) antiviral product. The bulk of the revenue from this contract is to be recognised across 2021 and 2022.  

In terms of market scope, analysts explained: “The lack of investment in infectious diseases by large pharma in recent years indicates that R&D should expand to $250b by 2025 according to the press release, representing a huge growth opportunity for Open Orphan.” 

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