ImmBio initiates First-in-Human studies of its novel pneumococcal vaccine, PnuBioVax
The PnuBioVax vaccine contains heat shock proteins and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent.
ImmunoBiology, a biopharmaceutical company developing next generation anti-infective vaccines based on its proprietary ImmBioVax technology, has initiated enrolment for a First-in-Human study of its novel vaccine (PnuBioVax) against the bacterial pathogen Streptococcus pneumoniae.
The study will look at the safety and tolerability of PnuBioVax for three different dosages compared to placebo. Each dose will be given as a prime and two boosts in male and female adults, in a double blind procedure. Conducted by Simbec Research Ltd at its site in Glamorgan, Wales, the study expects to enrol 36 volunteers, with results anticipated in Q2 2016. The primary endpoints of the study are safety and tolerability, as well as selected immunological markers of response. As a measure of secondary outcomes, a range of immunological assays will investigate the likely impact of the vaccine on asymptomatic carriage of the pathogen, and generation of key antibodies, including PnuBioVax’s ability to neutralise pneumolysin, a toxin produced by S. pneumoniae.
S. pneumoniae commonly resides asymptomatically in the nasal passages of healthy people. However, in susceptible individuals, such as the elderly, young children and the immunocompromised, it can propagate to the blood and vital organs, leading to life threatening diseases including meningitis, sepsis, pneumonia, endocarditis and pericarditis. Despite the availability of antibiotics, the death rate associated with pneumococcal disease, once invasive infection has occurred, is around 14%, making early preventative treatment vital.
There are over 90 serotypes of S. pneumoniae in circulation, and individual antibodies against the bacteria provide serotype-specific protection, making vaccine development challenging. Currently marketed vaccines are relatively expensive to produce and only target a limited number of serotypes each and, by their design, cannot cover emerging strains or serotype replacement.
ImmBioVax uses a novel process, incorporating heat shock proteins (HSPs). These proteins are produced by cells in response to stress, for example, heat, and are known to activate both the adaptive and innate arms of the immune response. The PnuBioVax vaccine contains HSPs and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent. Consequently PnuBioVax has the potential of being protective across a broad range of current and emergent serotypes, in contrast to currently-available products. In addition, the manufacturing process has a high yield and low production costs, with the potential of being more readily affordable.
“Preclinical studies of PnuBioVax have found its immune response to be serotype-independent, and we expect this to be reflected in the upcoming clinical trial,” said Dr Chris Bailey, Development Director at ImmBio. He continued: “We will be investigating multiple immunological outcomes based on T-cell and functional antibody responses.”
Graham Clarke, CEO of ImmBio, commented: “ImmBio aspires to create a universal vaccine for the huge unmet need of pneumococcal disease. Whilst this has proved elusive to date, we are encouraged that the unique multi-protein design of PnuBioVax offers a viable way to achieve this. Progression of PnuBioVax into First-in-Human studies provides validation of our progress in preclinical studies and manufacturing, and takes us a step closer to a potentially more effective and affordable vaccine for this life threatening disease.”
ImmBio’s commercial strategy is to develop its vaccine candidates through to proof-of-concept in man, and to find partners to progress late stage development, manufacturing and marketing.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance