Positive Trial Response brings COVIDITY Candidate into Development Arena

Cancer and infectious disease immunotherapies developer Scancell Holdings (Oxford, UK), has announced preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial. Conducted at the University of Cape Town (UCT) Lung Institute in South Africa, objectives were to assess the safety and immunogenicity of two vaccine candidates, SCOV1 and SCOV2, in healthy, vaccine-naïve subjects, prior to testing the candidates as a booster in SARS-CoV-2 pre-infected or pre-vaccinated volunteers. SCOV1 and SCOV2 are both plasmid DNA vaccines based on the Company’s ImmunoBody® technology and incorporate its AvidiMab® modifications to further enhance the immune responses.

The data from the Phase 1 COVIDITY trial showed that neutralising antibodies were induced as well as T cell responses to both the receptor binding domain (RBD) of the spike protein and the nucleocapsid antigen (NCAP). In vaccine-naïve subjects, the seroconversion rate (the level of detectable antibodies in the blood due to vaccination) was 67% following SCOV1/SCOV2 vaccination, with a broad reactivity against multiple COVID[1]19 variants, including the currently dominant Omicron variant. These positive results demonstrate that SCOV1 and SCOV2, which were delivered via a needle-free injection device, induce immune responses in naïve participants. Additionally, a single dose of SCOV2 boosted broad responses in previously exposed subjects.

Due to the large size of later stage trials and the competitive Covid-19 landscape, the company’s Board previously disclosed that it would not be taking this vaccine forward in-house; however with the positive data demonstrating the validation of the vaccine platform, the Company is now seeking a partner to progress the COVIDITY vaccine programme. The successful use of PharmaJet’s needle-free injection devices in the initial trial also provides the rationale for its incorporation in future trials.

Honorary Prof Rod Dawson, Managing Director of the University of Cape Town Lung Institute, commented: “We are delighted to report the positive immune response data from the COVIDTY trial. 66 participants were immunised with SCOV1, targeting the original A lineage of SARS-CoV-2 and/or SCOV2, targeting the Beta variant of concern. The results from the trial were highly encouraging, inducing neutralising antibody and T cell responses with no safety concerns.”

Prof Lindy Durrant, Chief Executive Officer of Scancell, commented: “These results are highly encouraging. Not only do they provide clinical proof of concept for the COVIDITY COVID-19 vaccine programme itself, more broadly they also provide important further validation and learnings for Scancell’s ImmunoBody® and AvidiMab® platforms. The success of a human trial demonstrating that an AvidiMab® modified DNA vaccine, delivered via a needle free injection, can induce both T cell and antibody responses, with no safety concerns, is a pivotal proof point for Scancell’s clinical strategy.

“Further large studies would be required to confirm the potential of the COVIDITY vaccine candidates to stimulate broad, cross-variant reactivity and compete with the currently approved COVID-19 vaccines. Therefore, and as previously disclosed, the Board has decided to seek a partner to further progress this programme. Going forwards, Scancell will focus its resources on progressing the portfolio of innovative immuno-oncology drug candidates that we have generated from our platforms.”

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