Press Releases:

Monday, 13 July 2020

 

Excivion announces collaboration with Centre for Process Innovation (CPI) to optimise and scale up production of safe and effective Zika vaccine

Excivion Ltd, Cambridge, UK, today announced a partnership with CPI to optimise the manufacture of Excivion’s novel Zika vaccine antigen candidate, Zika-HX, an integral component of any future vaccine formulation. Excivion’s technology could help to prevent future pandemics of deadly viruses by avoiding the adverse immune responses common in current vaccine candidates for Zika and related viruses.

Zika is a member of the Flavivirusgenus that includes dengue, yellow fever and tick-borne encephalitis. In the case of dengue virus, infection with one serotype may result in the generation of antibodies that can increase disease severity following infection with a second serotype. This process is known as antibody dependent enhancement (ADE). There is a significant risk that the vaccines in development to protect against flaviviruses may sometimes cause ADE and actually worsen the effects of the disease they are designed to prevent. Excivion’s flavivirus vaccine platform involves glycan-cloaking of the fusion-loop of the virus envelope protein, conferring protection  while avoiding the generation of fusion-loop antibodies that cause ADE. For its proprietary Zika virus vaccine Excivion is applying a DrosophilaS2 insect cell-based protein production system, ExpreS2, from ExpreS2ion Biotechnologies ApS, Horsholm, Denmark, thereby obtaining high quality recombinant ZIKV protein for the ongoing development project.   

Excivion have partnered with CPI to draw upon the company’s extensive experience in the optimisation and scale-up of biologics manufacturing processes. Over the next four months, CPI will proceed through a four-stage development programme including technology transfer, characterisation and upstream and downstream process development. Using its expertise and advanced technology housed at the National Biologics Manufacturing Centre, Darlington, CPI will work to characterise the structure of the purified Zika-HX antigen. A scalable downstream purification method for the required product forms will be optimised. The work on upstream processing will assess whether it is possible to control the oligomerisation state of the Zika-HX antigen within the existing bioprocess to maximise yield. CPI will have access to the initial bioprocessing data developed at ExpreS2ion.

Peter Laing, CEO at Excivion Ltd, said: “Throughout modern history, vaccines have proven to be the most cost-effective solution to disease prevention, however challenging manufacturing problems and the risk of ADE prevents more vaccines entering the market. I am pleased that ExpreS2ion’s production system has documented the initial bioprocessing needed to proceed as planned. Our partnership with CPI will enable us to optimise the purification of Zika-HX and proceed faster with its development into a vaccine.” 

Lucy Foley, Director of Biologics at CPI, said: “Excivion’s flavivirus vaccine platform has the potential to produce safe and effective vaccines for viruses that represent some of the world’s greatest pandemic risks. We are looking forward to contributing to the Zika-HX project with our expertise in biologic manufacturing, helping Excivion to efficiently produce pure active antigens.”

The research is delivered by the Future Vaccine Manufacturing Research Hub (FVMRH) at Imperial College London. The FVMRH is committed towards researching innovative and more cost-effective vaccines for populations in lower and middle-income countries (LMICs). The hub’s goal is to improve the way vaccines are manufactured, stabilised and stored in partnership with vaccine manufacturers in Italy, India, Vietnam, Bangladesh, Uganda and China, as well as translational research partners comprising of the National Institute for Biological Standards and Control (NIBSC), CPI and NHS Blood and Transplant.

 

Notes to the Editor

 

About Excivion

Excivion is a UK-based biotechnology company developing solutions to the present and emerging healthcare needs of society that are sustainable and affordable by healthcare systems in the face of competing priorities imposed by an ageing population and the emergence of pandemic diseases. Vaccines, historically, have proven the most cost-effective solution to disease prevention, but also have a formidable potential to treat diseases once they have arisen. Excivion is in the vanguard of a new pharmaceutical model for this changing world in which vaccines feature globally in both disease-prevention and in the treatment of chronic diseases. Excivion’s work on the Zika vaccine is fundedby the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). The funding is delivered by Innovate UK under its SBRI programme.

www.excivion.com

 

About CPI

CPI is an independent technology innovation centre and a founding member of the UK Government’s High Value Manufacturing Catapult. Founded in 2004, CPI applies its years of experience across a broad range of industries to ensure that every great invention gets the best opportunity to become a successfully marketed product. 

CPI’s integrated approach provides its partners with a unique combination of assets, expertise and skills to drive successful innovation. With a deep understanding of innovation processes and funding, outstanding technical expertise and industry-relevant assets, CPI enables products and process to be quickly and cost-effectively brought to market. By employing bright minds from both academia and industry, CPI helps create a bespoke team that will provide the right support, helping you to navigate the route to commercialisation while reducing risk along the way.

We form connections throughout the supply chain, bringing together investors, government organisations and academic institutions to facilitate the necessary partnerships for effective innovation. This increases productivity across industries and supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK. 

www.uk-cpi.com

 

About Innovate UK

Innovate UK is the UK’s Innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. www.innovateuk.gov.uk

 

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Excivion Presents at Seventeenth UK Hepacivirus and Flavivirus Meeting  - 17th-19th May 2019

Excivion Ltd. Announces the development of a novel point-of-care diagnostic to

facilitate the safe use of dengue vaccines in the field

 

- Excivion has developed an unique proprietary diagnostic to identify

 dengue-naive subjects who should be spared dengue vaccination -  

CAMBRIDGE, UK – (May 17, 2019) – Excivion Ltd (www.excivion.com) “Excivion”, a developer of novel vaccines for the prevention of emerging pandemic infectious diseases, today announced that it has developed a point-of-care diagnostic test with performance characteristics suitable, once licensed, to identify subjects who are dengue-naive and who should be spared dengue vaccination, in order to avoid the risk of priming for severe dengue. The current practice, required by the FDA, is that a laboratory-based test should be used for this purpose. However, the logistics of a laboratory-based test complicate the process of screening and there is general agreement that point-of-care is a better solution for the purpose 

(Luo et al PMID: 30664935, https://www.who.int/immunization/diseases/dengue/q_and_a_dengue_vaccine_dengvaxia_use/en/).

 

Commenting on the new development, Peter Laing, CEO of Excivion, said, "There are a number of point-of-care tests in existence for historic dengue, but these have limited sensitivity and have been hampered by the emergence of Zika as a pandemic disease - the tests being generally not capable of reliably distinguishing prior Zika from dengue.  In this instance we re-invented the point-of-care dengue test from the ground up, making it more sensitive and specific than licensed point-of-care tests, and better in these respects than many lab-based tests. We also made the test 'scaleable' to be manufacturable in the millions. In order to scientifically validate the test we made extensive use of plaque neutralisation assay which is the current 'gold standard', albeit requiring culture of live virus. The next step for us is to achieve licensing of the test as a companion diagnostic for dengue vaccines. We are currently seeking partners and philanthropic funding to bring this about. We further anticipate that Zika vaccines in development may require the use of the test as a companion diagnostic, in order to avoid priming for severe dengue in dengue-naive subjects."

The diagnostic has a number of proprietary innovations and exploits Excivion's unique glycan-cloaking technology which places an 'invisibility cloak' over the major cross-reactive site of the dengue and Zika antigens, such that cross-reactive antibodies (that would otherwise result in mis-diagnosis) can not be detected in the test which is highly specific for dengue antibodies. The compositions of matter and novel test architecture are protected by two PCT stage patent applications, the first of which (on the cloaked antigens), having entered the National Phase, is now pending in thirteen territories world-wide. Both of these applications have received very favourable PCT examination reports.

Peter Laing went on to say "The generous support and validation of the UK Government who are funding this work via a contract under the Small Business Research Initiative (SBRI) from the UK’s innovation agency, Innovate UK is gratefully acknowledged. Without their help we would never have been able to develop the test.” 

 

About Excivion

Excivion is a UK-based biotechnology company developing solutions to the present and emerging healthcare needs of society that are sustainable and affordable by healthcare systems in the face of competing priorities imposed by an ageing population and the emergence of pandemic diseases. Excivion is producing novel vaccines that can be used to prevent emerging pandemic infectious diseases and to prevent and treat chronic diseases of ageing. Vaccines, historically, have proven the most cost-effective solution to disease prevention, but also have a formidable potential to treat diseases once they have arisen. Excivion is in the vanguard of a new pharmaceutical model for this changing world in which vaccines feature globally in both disease-prevention and in the treatment of chronic diseases.

 

About Innovate UK

Innovate UK is the UK’s Innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. www.innovateuk.gov.uk

 

 

Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of NGS cancer panels, the ability to accurately determine the heritable factors increasing the risk of cancer, permitting tailored treatment, screening and prevention of cancer in patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Source: Excivion Ltd.