Scancell Holdings PLC - Nottingham, England-based cancer immunotherapies developer - Updates on South African Health Products Regulatory Authority’s approval of a protocol amendment to the phase 1 Covidity clinical trial being conducted at the University of Cape Town Lung Institute in South Africa.

Says SAHPRA has approved a protocol amendment that now allows recruitment of volunteers who have previously been infected with SARS-CoV-2 irrespective of their vaccination status and also volunteers that are vaccinated but not infected with SARS-CoV-2. Says this amendment enables testing of Covidity in a ‘real-world setting’ and will provide ‘meaningful’ safety and immunogenicity data when volunteers are boosted. It is also expected that the expansion of the trial population will accelerate recruitment into the study.

Chief Executive Officer Lindy Durrant comments: ‘With this amendment to the COVIDITY trial allowing us to expand the patient population to reflect a real-world setting, we believe we will be better able to capture meaningful safety and immunogenicity data. Additionally we anticipate this will accelerate recruitment of volunteers in our COVIDITY Phase 1 clinical trial, and look forward to announcing data later in 2022.’

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