hVIVO in vaccine development joint venture investment with SEEK Group
Phase IIa clinical study of universal flu vaccine in the hVIVO platform planned and Zika vaccine Phase I clinical study expected to begin later this year
hVIVO, the UK-based pioneer of human models of disease, thas entered into a joint venture investment with the SEEK Group to develop vaccines against influenza and mosquito-borne diseases, such as Zika and other flaviviruses. The joint venture investment in a new company, Imutex, strengthens hVIVO’s commercial flu portfolio and expands it into the adjacent therapeutic area of mosquito-borne diseases, with immediate focus on Zika.
The development of universal flu and Zika vaccines are key public health priorities identified by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) in the United States. Imutex will collaborate with the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate development of both vaccines this year. Depending upon the outcomes of these studies, Imutex may also pursue Fast Track designation for these vaccines.
Imutex will be leveraging 'universal flu' technology licensed from SEEK to develop a broad spectrum vaccine, called FLU-v, against multiple flu strains. FLU-v works by targeting conserved internal proteins common to all flu viruses to activate T and B-cells, key components of the human immune system response. The success of such an approach would eliminate the sensitivity to strain variability seen with traditional vaccines and promote single vaccine coverage for all flu strains.
Working closely with NIAID, Imutex will be leveraging the hVIVO platform to conduct a Phase IIa clinical study of FLU-v to evaluate the efficacy and safety of this novel vaccine. Study design is well advanced and the Phase IIa study is expected to commence in the near future.
In the case of Zika, Imutex will be leveraging mosquito-borne disease vaccine technology licensed from SEEK to develop a novel vaccine that has a proposed dual action mechanism, aiming to prevent infection in humans and also to control the mosquito population. It works by creating an anti-saliva immune response in humans that prevents infection. In addition, after the mosquito bites a vaccinated human host, antibodies from the human attack the gut and salivary glands of the mosquito which reduces the survival of the mosquito. If successful in its imminent Zika clinical study, Imutex will further develop the technology in other mosquito-borne illnesses, including malaria, dengue and West Nile.
Imutex will collaborate with the NIAID team to perform the vaccine’s First in Man Phase I clinical trial in the NIH Clinical Center in Bethesda, MD in the coming months.
hVIVO is acquiring a 49% equity stake in Imutex for £7m in cash consideration and SEEK is contracting with hVIVO Services Limited to conduct a FLU-v Phase IIa clinical study in 2016 for £5.5m. hVIVO expects to account for its investment as a joint venture in its balance sheet and, in applying the equity method as a joint venture, recognise the £5.5m FLU-v Phase IIa clinical study as revenue. SEEK owns a 51% equity stake in Imutex and is granting Imutex a worldwide licence of the flu and mosquito-borne disease vaccine platforms and providing services (including the FLU-v Phase IIa clinical study) in exchange for £7m in cash consideration and a downstream commercialisation royalty.
'We are delighted to be working with SEEK in a joint venture investment to advance such ground-breaking vaccine technology against the backdrop of an emerging public health crisis,' said Kym Denny, hVIVO’s Chief Executive Officer. 'Addressing flu’s unmet medical need is a key strategic driver for hVIVO and this collaboration allows us to advance that objective while simultaneously broadening our reach into the adjacent therapeutic area of mosquito-borne diseases. We look forward to working closely with our colleagues at SEEK and NIAID in the development of these two key vaccines.'
'We believe the combined capability and insight of SEEK with hVIVO and NIAID will add significant value to our vaccine platform development,' said Gregory Stoloff, Chief Executive Officer of SEEK. 'The joint venture investment in Imutex creates a vehicle to leverage speed of trial conduct with world class science and development expertise. We look forward to accelerating these two assets through their upcoming trials quickly, in order to bring safe and effective vaccines to market rapidly and economically.'
