Scancell, the developer of novel immunotherapies for the treatment of cancer and infectious disease based at The Oxford Science Park, has announced an update on its COVIDITY clinical trial plans and the publication of preclinical data on two vaccine candidates from its COVIDITY research programme.
The COVIDITY programme is a collaboration between Scancell and scientists in the newly established Centre for Research on Global Virus Infections and the new Biodiscovery Institute at the University of Nottingham and Nottingham Trent University. The programme has received funding from Innovate UK.
Following findings from the preclinical data, a Phase 1 study on this next-generation vaccine will commence in South Africa and the UK in the second half of this year, subject to local regulatory approvals.
These next-generation COVID-19 vaccines could offer improved protection against new SARS-Cov-2 variants of concern (VoC) due to the inclusion of the highly conserved nucleocapsid N antigen in addition to the more variable spike (S) protein. Based on the potent immune responses generated in these preclinical studies, Scancell plans to test the safety and immunogenicity of SCOV1and SCOV2 in a Phase 1 clinical trial.
A regulatory application to initiate a Phase 1 clinical trial of COVIDITY has been submitted to the South African Health Products Regulatory Authority (SAHPRA). Part 1 of this study will be conducted at the University of Cape Town Lung Institute, South Africa, in COVID-19-naïve unvaccinated, healthy adult volunteers.
Such a study is not possible in the UK because of the rapid rollout of the vaccination programme. The objective of the study will be to assess the safety and immunogenicity of the two candidates in unvaccinated individuals with two cohorts assessing different doses of SCOV1 and SCOV2 using two different needle-free injection methods.
After a demonstration of safety in Part 1 of the COVIDITY study in South Africa, Scancell will seek approval from the Medicines & Healthcare products Regulatory Agency (MHRA) to initiate a UK extension of the study in which SCOV2 will be given to healthy volunteers who have already received two doses of an approved vaccine.
The immune responses from this UK part of the COVIDITY study will allow the company to assess the ability of SCOV2 to boost the immune response against current and potential future strains of COVID-19 in pre-vaccinated individuals.
In October 2020, the company entered into a collaboration with Cobra Biologics, part of the Cognate BioServices family, to conduct preliminary work leading to the manufacture of plasmids for Scancell’s COVID-19 vaccine.
Dr Cliff Holloway, Chief Executive Officer, Scancell, said: “There is a significant threat from future mutations of the SARS-CoV-2 virus, as we have seen with the rapid transmission of the Delta variant. Our next generation COVID-19 vaccine has the potential to work alongside currently approved vaccines by protecting the population against new variants of SARS-CoV-2. We look forward to initiating this trial in South Africa and the UK and to updating the market in due course on further developments from the COVIDITY programme.”