CTA approval confirms H221 COVIDITY Phase I start

Lighthouse | 30 July 2021

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  • Scancell has received South African Health Products Regulatory Authority (SAHPRA) approval of the CTA (clinical trial application) for the Phase I clinical study (COVIDITY-001) of COVIDITY, its second generation COVID-19 vaccine programme.
  • The two-part COVIDITY-001 trial is expected to initiate in H221. Part 1 will be run in South Africa only (at the University of Cape Town Lung Institute) as the successful roll-out of the UK vaccination programme has limited the available pool of COVID-19-naïve subjects. Part 2 will be a UK-based extension in pre-vaccinated individuals.
  • Part 1 will study the two lead bivalent vaccine candidates, SCOV1 and SCOV2, that target the original and variant SARS-CoV-2 virus respectively, in COVID-19-naïve unvaccinated, healthy adult volunteers. The main objectives of Part 1 are assessment of safety and immunogenicity (virus-neutralising antibody, VNAb, levels and T cell responses to the N protein) of two different dose levels delivered via two difference needle-free injection formulations.
  • Once safety has been established in Part 1 and subject to Medicines and Healthcare products Regulatory Agency (MHRA) approval, Scancell intends to initiate Part 2. This will evaluate SCOV2 in healthy volunteers who have received two doses of a currently approved vaccine. The objective of Part 2 is to assess SCOV2’s ability to boost the immune response in pre-vaccinated individuals against existing and potential SARS-CoV-2 variants of concern.
  • Separately, Scancell has announced a change in CEO, with founder and CSO Professor Lindy Durrant taking the reins from Dr Cliff Holloway. Professor Durrant has previously been Scancell’s co-CEO.

Trinity Delta view: The COVIDITY vaccine programme is only one facet of Scancell’s investment case but represents a high-profile demonstration of its technological expertise. If data read out in 2022 corroborates the thesis that COVIDITY’s dual mechanism of action confers a protective effect against any SARS-CoV-2 variants (including Delta) and other emergent SARS-CoV viruses, it would confirm a differentiated scientific and competitive profile.

Scancell’s three technology platforms (ImmunoBody, Moditope, and AvidiMab) underpin a therapeutic pipeline directed towards several solid tumour types, either as monotherapies or in combinations. Its solid balance sheet and expanding infrastructure mean that Scancell is well positioned to progress its most commercially promising assets into and through clinical development. Successful execution has the potential to generate substantial long-term value. However, with a change in management and in line with our policy, we suspend our forecasts and valuation with the intention of reinstating these pending an update on any changes to strategic priorities and/or timelines.


30 July 2021

Market Cap£175m
Primary exchangeAIM London
Company CodeSCLP
Corporate clientYes

Company description

Scancell is a clinical-stage immuno-oncology specialist that has three technology platforms. Two flexible therapeutic vaccine platforms are progressing through development. ImmunoBody and Moditope induce high avidity cytotoxic CD8 and CD4 responses, respectively, with the potential to treat various cancers.


Lala Gregorek
+44 (0) 20 3637 5043

Franc Gregori
+44 (0) 20 3637 5041


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