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COVID and Unmet Needs

SARS-CoV-2 is a zoonotic strain of coronaviruses that was introduced to human populations in the Chinese province of Hubei in late 2019. The spread of infection has since been driven by human-to-human transmission resulting in the 2020-2021 pandemic.

As a result of unprecedented public and private sector initiatives, as well as the advent of mRNA and viral vector technologies, new vaccines against COVID-19 disease received regulatory clearance in multiple countries in record time.  Still, a multi-year track record of safety and efficacy of these new platforms has yet to be established with vulnerable populations, especially those most directly impacted by the current pandemic – the elderly. Additionally, mRNA vaccines require expensive supply chain support, and there may be certain limitations to the viral vector-based products. Coupled with new mutations of the SARS-CoV-2 virus identified in South Africa and the UK for which the new vaccines may or may not provide robust protection, there may be the need for traditional subunit vaccines or virus-like particle alternatives, particularly constructs that can be cost-effectively designed, prototyped, and mass produced in rapid fashion.

iBio’s Approach

Having only just begun our  own proprietary product development initiatives in December 2019, we sought to try the FastPharming® System’s capabilities with the new, emerging SARS coronavirus in late January 2020, even though the pandemic to come was not envisioned at the time. Within five weeks, we designed and manufactured constructs using two platforms, one a virus-like particle [VLP], and the other a subunit vaccine that combines antigenic sequences derived from SARS-CoV-2 virus spike protein fused with our  patented LicKMTM booster molecule.

Subsequent preclinical studies with an array of adjuvants suggested the subunit vaccine, IBIO-201, held more promise.  So, additional work is being conducted not only to establish the platform (e.g. toxicology studies on viral proteins fused to LicKM), but to explore other viral proteins that may provide protection against the new coronavirus mutations.

Development Status

IBIO-201 completed preclinical studies to evaluate immune responses in mice and generation of neutralizing antibodies to SARS-CoV-2 spike protein in 2020. In vivo toxicology studies are in progress to further evaluate IBIO-201.