Scancell Holdings Regulatory News (SCLP)

5th October 2021

Scancell Holdings plc

("Scancell" or the "Company")

First subject dosed in COVIDITY Phase 1 clinical trial in South Africa

Novel bivalent COVID-19 vaccine based on ImmunoBody® DNA vaccine technology

SCOV1 administered using clinically proven PharmaJet Needle-free Injection System

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that the first subject has been dosed in its COVIDITY clinical trial being conducted at the University of Cape Town (UCT) Lung Institute in South Africa. The COVIDITY programme 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 and the programme has received funding from Innovate UK.

The objectives of Part 1 of the trial are to assess the safety and immunogenicity of two vaccine candidates, SCOV1 and SCOV2, which target the original and variant SAR-CoV-2 viruses, respectively, in healthy, vaccine-naïve subjects. The study will determine the immunological responses induced by the vaccines administered by two alternative injection routes using two PharmaJet needle-free delivery systems. In addition to measuring virus neutralising antibodies (VNAbs) induced by the viral spike (S) protein, the Company will also analyse the T cell responses to the highly-conserved nucleocapsid (N) protein, which will provide further information and data on the potential utility of both SCOV1 and SCOV2 against future SARS-CoV-2 variants, including the Delta variant.

SCOV1 and SCOV2 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. After demonstration of safety in the South African part of the study, the Company plans to 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 results from this part of the study will allow the Company to assess the strength and breadth of the immune responses induced in pre-vaccinated individuals, with the potential to provide durable protection against emerging variants.

Honorary Prof Rod Dawson, Managing Director of the University of Cape Town Lung Institute, commented: "Novel vaccine candidates are required to increase the cover, strength and durability of the global COVID-19 vaccination platform. The UCT Lung Institute is excited to partner with Scancell to investigate these promising new COVID-19 vaccine candidates."

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "We are delighted that we have been able to start this trial so quickly following regulatory approval in South Africa. The Scancell team and collaborators have worked diligently since the start of the pandemic to design, characterise, manufacture and deliver this second generation COVID-19 vaccine and we look forward to evaluating its clinical potential with our colleagues in South Africa."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its technology platforms, ImmunoBody®, Moditope® and AvidiMabTM, with four products in multiple cancer indications and development of a vaccine for COVID-19.

ImmunoBody® vaccines target dendritic cells and stimulate both CD4 and CD8 T cells with the ability to identify, target and eliminate cancer cells. These cancer vaccines have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. The Directors believe that this platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

DNA vaccine against COVID-19: As research data emerges, it is becoming increasingly clear that the induction of potent and activated T cells may play a critical role in the development of long-term immunity and clearance of virus-infected cells. Initial research is underway and Scancell anticipates initiating a Phase 1 clinical trial known as COVIDITY during 2021.

Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). Examples of such modifications are citrullination, an enzyme-based conversion of arginine to citrulline, and homocitrullination (or carbamylation), in which lysine residues are converted to homocitrulline. Expression of peptides containing these modifications have been demonstrated to induce potent CD4 cytotoxic T cells to eliminate cancer. The Directors believe that this platform has the potential to eradicate hard to treat solid tumours.

AvidiMab™ has broad potential to increase the avidity or potency of any therapeutic monoclonal antibody (mAb) including those being developed for autoimmune diseases, as well as cancer. Scancell's development pipeline includes mAbs against specific tumour-associated glycans (TaGs) with superior affinity and selectivity profiles, that have now been further engineered using the Company's AvidiMab™ technology; this confers the Scancell anti-TaG mAbs with the ability to directly kill tumour cells. The mAbs targeting TaGs can also be used to deliver cytotoxic payload to cancer or to redirect T cells. The Company has entered into three non-exclusive research agreements with leading antibody technology companies to evaluate the Company's anti-TaG mAbs including those enhanced with the AvidiMab™ technology.