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    SCLP   GB00B63D3314

SCANCELL HOLDINGS PLC

(SCLP)
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Scancell Holdings plc Announces South African Health Products Regulatory Authority Approves Clinical Trial Application for the Phase 1 Clinical Study of COVIDITY (COVIDITY -001) in South Africa

07/29/2021 | 02:00am EDT

Scancell Holdings plc announced that the South African Health Products Regulatory Authority (SAHPRA) has approved the clinical trial application (CTA) for the Phase 1 clinical study of COVIDITY (COVIDITY-001) in South Africa. The COVIDITY programme, focused on the Company's novel COVID-19 vaccine candidates SCOV1 and SCOV2, 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. SCOV1 and SCOV2, targeting the original and variant SARS-CoV-2 viruses, respectively, are based on a modification of Scancell's ImmunoBody® DNA vaccine technology and have a dual mechanism of action to induce high avidity T-cell immune responses against both the N and S viral antigens. Targeting the receptor-binding domain (RBD) of the S antigen, the vaccines also elicit high titre virus-neutralising antibodies (VNAbs) that cross-react against a range of Variants of Concern (VoC), including the new Delta variant. The regulatory application to initiate a Phase 1 clinical trial of COVIDITY has been approved by the South African Health Products Regulatory Authority (SAHPRA) and it is anticipated that the study will start in H2 2021. This part of the study will be conducted at the University of Cape Town Lung Institute, South Africa, in unvaccinated, healthy adult volunteers. UK sites could not be included in this part of the study due to the rapid rollout of the UK vaccination programme and resulting lack of vaccine-naïve subjects required for the initial safety evaluation. The objectives will be to assess the safety and immunogenicity of the two vaccine candidates, SCOV1 and SCOV2, evaluating different vaccine doses delivered by two alterative injection routes using needle-free systems. In addition to evaluating the VNAbs, the Company will also analyse the T cell responses to the N protein, which will provide additional information and data on the potential utility of both SCOV1 and SCOV2 against future SARS-CoV-2 variants. After demonstration of safety in Part 1 of the 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 COVIDITY will be given to healthy volunteers who have already received two doses of an approved vaccine. The immune responses from this 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.


ę S&P Capital IQ 2021
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Financials
Sales 2021 - - -
Net income 2021 -8,38 M -11,4 M -11,4 M
Net cash 2021 17,4 M 23,8 M 23,8 M
P/E ratio 2021 -12,1x
Yield 2021 -
Capitalization 177 M 242 M 242 M
EV / Sales 2021 -
EV / Sales 2022 -
Nbr of Employees 22
Free-Float 90,0%
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Number of Analysts 1
Last Close Price 21,75 GBX
Average target price 18,40 GBX
Spread / Average Target -15,4%
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Managers and Directors
Lindy Gillian Durrant Chief Executive Officer & Executive Director
Keith Green Director-Finance & Administration
John C. Chiplin Executive Chairman
Gillies O'Bryan-Tear Chief Medical Officer
Robert Matthew Miller Medical Director
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