In June 2023 Blue Water Biotech announced preliminary preclinical data in support of the use of a norovirus shell and protrusion (S&P) virus-like particle (VLP) platform to develop an mpox vaccine candidate. During last year’s global mpox scare to a “pandemic-weary world”, doses of the Bavarian Nordic smallpox vaccine were repurposed against mpox. As cases subside, some may be questioning efforts to pursue a novel candidate. However, for researchers at Blue Water, there is a medical need to be met.  

“Hyperlow endemicity” 

One of the tragedies of mpox is the fact that it took a global flare up to accelerate efforts to contain the virus, rarely found outside Africa. We noted almost a year ago that Dr Ahmed Ogwell Ouma, then acting Director of Africa CDC, was calling for vaccines on the continent to stop it at the “source”. However, mpox has not disappeared, despite the unprecedented efforts of vulnerable communities to remain vigilant. Dr Andrew Noymer from the University of California Irvine told Fierce Biotech that it has reached “hyperlow endemicity”.  

“It has established itself at a very low level and hasn’t gone away…We really do have a disease that has persisted.” 
Meeting a need 

Considering the effectiveness of prevention and containment efforts so far, the question of whether there is a need for a new vaccine arises. For Joseph Hernandez, founder and CEO at Blue Water, the team have an “obligation” to pursue a “tool” that could outperform current options. Blue Water notes that “limited availability” of current vaccines is presents another case for expanding the toolkit.  

Taking the first steps 

Blue Water set out intentions to explore a novel candidate in August 2022. The plan was to present mpox antigens within the S&P platform, following which mice were immunised and analysed for antibody levels in the blood.  

“Initial data show that mice were able to generate an immune response following vaccination and antibodies were able to neutralise the vaccinia virus.” 

Vaccinia is the virus responsible for smallpox, which is of the same family as mpox and has demonstrated high levels of cross-reactivity. Mr Hernandez is “thrilled” at the “exciting initial step” towards a vaccine candidate. 

“This platform has shown wide versatility across multiple infectious diseases…and we are excited to continue to work towards a next generation mpox vaccine.”  

He emphasised that the development programmes “continue with success” despite the company’s focus on the commercialisation of “recently acquired FDA approved assets”. Dr Ali Fattom, Head of Science and Discovery at Blue Water, remarked that the data are “promising”. 

“Current vaccines utilise the entire vaccinia virus, while our approach selects targeted antigens hypothesised to generate robust immune responses.”  

Dr Fattom hopes to create an “effective vaccine to protect individuals around the world.” 

“Armed with information from this preliminary study, we can confidently move forward in preclinical development and initiate studies to show protective immunity in relevant animal models, with the ultimate goal of bringing this candidate to clinical trials and commercialisation.”  

Without publicised data, it’s hard to comment on the efficacy of the candidate, but Dr Shyamala Ganesan, senior director of vaccine research and development at Blue Water, told Fierce Biotech that intramuscular injection was the favoured approached, allowing for careful selection of the antigens against which to mount an immune response. Finally, with few contenders on the path towards a successful candidate, Blue Water is hoping to make quick progress to catch up with Moderna.  

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