Intravacc to develop emergency and conventional COVID-19 vaccines

Bilthoven, The Netherlands – 08.00 CET, May 14, 2020 – Intravacc, one of the leading translational research and development vaccine institutes with an extensive track record in developing viral and bacterial vaccines, today announced the development of three COVID-19 vaccine concepts. These concepts are all based on Intravacc’s platform technologies, that have been proven safe in humans.

“This global COVID19 pandemic requires an international effort to understand the complexity of the disease and to develop innovative COVID-19 emergency and conventional vaccines”, said Dr. Jan Groen CEO of Intravacc. “We also need to establish partnerships with pharma for large scale manufacturing and global distribution of these vaccines”.

To develop safe and effective COVID-19 vaccines, Intravacc is focusing on emergency and conventional vaccines. Intravacc’s emergency vaccine is designed to activate cytotoxic T-cell responses. This emergency vaccine would reduce mortality and morbidity and as a result reduces the pressure on the public health system. For this vaccine Intravacc uses its outer membrane vesicle (OMV) technology.

For its conventional COVID-19 vaccine Intravacc will use OMV’s as a carrier for spike proteins of the virus to induce a protective antibody response. For the third concept Intravacc’s approved Vero cell platform will be used to develop an intranasal vector vaccine based on Newcastle disease virus, that can replicate in humans but does not cause disease.

The expected development timelines for these COVID-19 vaccines to enter into phase 1 range from 9 to 21 months.

About OMV platform technology

Gram-negative bacteria naturally release vesicles from their outer membrane. Outer membrane vesicles (OMVs) harbor bacterial proteins that play a role in establishing infection and survival of the bacterium within the human host. They are very suitable vaccine candidates. Genetic engineering techniques are being used to achieve the required antigenic composition, and to optimize immune modulating properties and safety. OMV’s are safe in humans and can be injected

or administered needle free via the oral or intranasal route to achieve mucosal immunity. Intravacc’s OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by conjugating antigens to stockpiled carrier OMVs.

About the Vero cell platform

Intravacc’s viral vaccine production processes is based on a cGMP-grade, regulatory approved, Vero cell line. This platform is being used for routine large- scale commercial vaccine manufacturing by clients world-wide. In addition, virus seed lots and clinical batches have regularly been produced on the Vero cells, for example Poliovirus, Enterovirus (EV71), and Respiratory Syncytial Virus (RSV).

During the past decade, EV D68 infections have notably increased in North America, Europe and Asia. In 2014, the United States experienced a large outbreak of severe respiratory disease caused by EV D68, which is increasingly been recognized as a significant respiratory pathogen in children. No effective vaccines or antiviral drugs are currently available, and it is anticipated that the virus may cause larger outbreaks in the future. In this contract, an inactivated EV D68 vaccine will be developed up to first-in-human testing, including virus rescue, assay and process development, preclinical and toxicology studies and production of clinical trial material. The EV D68 vaccine to be developed under the contract will be the first AFM vaccine to go through to clinical development. The project has been funded in whole or in part with US Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93020C00037.

Dr. Jan Groen, Intravacc’s Chief Executive Officer, comments:
“We are gratified to enter into this co-development contract with the NIH/NIAID for an inactivated EV D68 vaccine to protect children from AFM in foreseen EV D68 outbreaks. Intravacc has a strong track record and expertise in the development of enteroviral vaccines for e.g. polio and Hand, Foot, Mouth disease on our unique Vero cell platform. For Intravacc this contract means a major recognition to be able to extend our portfolio with such a novel groundbreaking vaccine.”

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