LONDON: Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announced an update regarding the South African Health Products Regulatory Authority’s (SAHPRA) approval of a protocol amendment to the Phase 1 COVIDITY clinical trial being conducted at the University of Cape Town (UCT) Lung Institute in South Africa.
The change to the clinical trial protocol expands the populations able to participate in the Company’s COVIDITY study, a statement said.
The SAHPRA has approved a protocol amendment that, in addition to dosing healthy, vaccine-naïve non-infected subjects, now allows recruitment of volunteers who have previously been infected with SARS-CoV-2 irrespective of their vacciaton status and also volunteers that are vaccinated but not infected with SARS-CoV-2. 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.
The Phase 1 trial is testing Scancell’s two clinical candidates, SCOV1 and SCOV2 (COVIDITY), which in preclinical models have induced high titre antibodies and potent T cells against both the S and N antigens, including responses that cross-react with the Delta and Omicron variants. The objectives of the trial remain to assess the safety and immunogenicity of COVIDITY, with study data expected to be available in H2 2022. To date, 22 vaccine-naïve subjects have been enrolled and the COVIDITY immunisations have been well tolerated, with no safety concerns.
Honorary Prof Rod Dawson, Managing Director of the University of Cape Town Lung Institute, commented: “Despite the registration of vaccines and therapies for COVID-19, SARS-CoV-2 continues to have a profound burden on health care systems and economies across the globe. Highly effective vaccines providing robust protection to people remains to be an unmet need. We are delighted to be supporting the team at Scancell in researching COVIDITY in the real-world setting.”
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: “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.”