Oxford and Serum Institute of India sign IP license agreement to advance NipahB vaccine candidate

Under the terms of the agreement, SII has been granted a non-exclusive, worldwide licence in the field of Nipah virus vaccines, enabling the company to support the development, manufacture and potential future supply of the vaccine candidate developed at the University of Oxford.

Nipah virus is a zoonotic pathogen associated with severe disease and high mortality, with outbreaks reported primarily in South and Southeast Asia since it was first identified in Malaysia in 1999. Despite the significant threat it poses to public health, there are currently no approved vaccines available to prevent Nipah virus infection.

The development of the ChAdOx1 NipahB vaccine candidate is being funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and is based on the ChAdOx1 viral vector platform developed at the University of Oxford. Preclinical studies have demonstrated promising results, including strong immune responses in animal models and protection against infection in two in-vivo models.

Clinical-grade vaccine has been produced and a Phase 2a clinical trial has been initiated to evaluate the candidate’s safety and immunogenicity in humans. Subject to the results of these early studies, the programme is expected to progress to further clinical evaluation, including Phase 2b trials in regions where Nipah virus outbreaks occur.

Because outbreaks are typically sporadic and relatively small, conventional large-scale efficacy trials may be difficult to conduct. Regulatory pathways may therefore rely on a combination of clinical safety and immunogenicity data, preclinical evidence and data collected during outbreak responses, alongside established regulatory frameworks for vaccines against emerging infectious diseases.

Professor Brian Angus, Professor of Medical Practice at the Nuffield Department of Medicine, University of Oxford, and Chief Investigator of the trial at the Oxford Vaccine Group, said: 'With mortality rates of up to 70%, and recurring outbreaks across South and Southeast Asia, Nipah virus poses a serious and ongoing threat to vulnerable communities. Our focus at Oxford is to turn scientific discovery into vaccines that could help prevent future outbreaks and save lives, and this collaboration with the Serum Institute of India represents an important step towards achieving that goal.'

Dr Umesh Shaligram, Executive Director, Serum Institute of India Pvt. Ltd., said: 'Serum Institute of India is pleased to collaborate with the University of Oxford to advance the development of the ChAdOx1 NipahB vaccine candidate. Drawing on our experience with the ChAdOx1 platform and our global manufacturing capabilities, we look forward to supporting the continued clinical development of this vaccine candidate and contributing to efforts to strengthen preparedness against emerging infectious diseases such as Nipah virus.'

Oxford University Innovation (OUI), the University’s innovation partner, supported the licensing arrangement between the University of Oxford and Serum Institute of India, to advance the ChAdOx1 NipahB vaccine candidate towards development and manufacture.

Dr Matthew Carpenter, Deputy Head of Licensing and Ventures for Life Sciences at OUI, said: 'We’re proud to have supported the University in securing this licensing arrangement with Serum Institute of India. In the context of emerging infectious diseases such as Nipah virus, choosing the right partner is critical. Our role is to help move promising research from the laboratory into the hands of organisations with the expertise and scale to develop and deliver vaccines where they’re needed most. This agreement reflects Oxford’s commitment to translating scientific discovery into global health impact.'

Dr Richard Hatchett, CEO, CEPI, said: 'Nipah virus remains one of the world’s most dangerous pathogens, capable of triggering severe outbreaks with high mortality and with no approved vaccines currently available. Building on CEPI’s significant investments to advance global Nipah virus preparedness, we are proud to support the development of the ChAdOx1 NipahB vaccine candidate. This collaboration between the University of Oxford and the Serum Institute of India exemplifies the power of pairing scientific innovation with world-class manufacturing capabilities. Together, we are strengthening the global ecosystem needed to rapidly develop, produce and deliver vaccines in response to future Nipah outbreaks, wherever they may occur.'