Last checked at 29 Mar 2022 07:00
29 March 2022
Scancell Holdings plc
("Scancell" or the "Company")
Broadening of COVIDITY Phase 1 clinical trial in South Africa
SAHPRA approves clinical trial amendment allowing testing of COVIDITY vaccine candidate in a real-world setting
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces 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.
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."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please contact: |
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Scancell Holdings plc | +44 (0) 20 3727 1000 |
Dr John Chiplin, Executive Chairman |
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Professor Lindy Durrant, CEO |
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Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) | +44 (0) 20 7886 2500 |
Freddy Crossley / Emma Earl (Corporate Finance) |
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Rupert Dearden (Corporate Broking) |
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Stifel Nicolaus Europe Limited (Joint Broker) | +44 (0) 20 7710 7600 |
Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare Investment Banking) |
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Nick Adams / Nick Harland (Corporate Broking) |
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FTI Consulting | +44 (0) 20 3727 1000 |
Simon Conway / Rob Winder / Alex Davis |
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About Scancell
Scancell is a clinical stage biopharmaceutical company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate novel medicines to treat significant unmet needs in cancer and infectious disease. The Company is building a pipeline of innovative products by utilising its four technology platforms: Moditope® and ImmunoBody® for vaccines and GlyMab™ and AvidiMab® for antibodies.
Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs. The Company's unique approach is that its innovative products target modifications of proteins and lipids. For the vaccines (Moditope® and ImmunoBody®) this includes citrullination and homocitrullination of proteins, whereas its mAb portfolio targets glycans or sugars that are added onto proteins and / or lipids (GlyMab™) or enhances the potency of antibodies and their ability to directly kill tumour cells (AvidiMab®).
For further information about Scancell, please visit: https://www.scancell.co.uk/