Scancell Holdings Regulatory News (SCLP)

24 April 2020

Scancell Holdings plc

("Scancell" or the "Company")

Scancell to initiate development of novel DNA vaccine against COVID-19

Scancell Holdings plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that it has initiated a research programme to develop a vaccine for COVID-19. The project will be led by Professor Lindy Durrant, Chief Scientific Officer and Professor of Cancer Immunotherapy at the University of Nottingham, in collaboration with 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 University1.

Scancell's DNA vaccines target dendritic cells to stimulate high avidity T cells that survey and destroy diseased cells. This approach was highly successful with Scancell's lead ImmunoBody® cancer vaccine, SCIB1, which was safely administered to patients with malignant melanoma, and mediated excellent 5-year survival in a Phase 1/2 clinical trial. Scancell's aim is to utilise its proven clinical expertise in cancer to produce a simple, safe, cost-effective and scalable vaccine to induce both durable T cell responses and virus neutralising antibodies (VNAbs) 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. Although other vaccines may reach the clinic earlier, the Company believes its combined T cell and antibody approach should give more potent and long-lasting responses, ultimately leading to better protection.

SARS-CoV-2 is the virus that causes COVID-19. Scancell's DNA vaccine will target the SARS-CoV-2 nucleocapsid (N) protein and the key receptor-binding domain of the spike (S) protein to generate both T cell responses and VNAbs against the SARS-CoV-2 virus. The N protein is highly conserved amongst coronaviruses; therefore, this new vaccine has the potential to generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future.

Initial research is underway and Scancell anticipates initiating a Phase 1 clinical trial ("COVIDITY") in Q1 2021, subject to funding. The Company is actively seeking development partners and additional funding (including non-dilutive funding from governments and global institutions) to support the rapid development of this vaccine.

Professor Lindy Durrant, Chief Scientific Officer, Scancell, commented:

"As the COVID-19 pandemic has unfolded, Scancell has been evaluating how it can best contribute its expertise and resources to help in the global response. Vaccines are the long-term solution and we believe our combined high avidity T cell and neutralising antibody approach has the potential to produce a second-generation vaccine that will generate an effective and durable immune response to COVID-19."

Professor Jonathan Ball, Director of the Centre for Research on Global Virus Infections at the University of Nottingham added:

"Focusing the antibody responses on the receptor binding domain of the SARS-CoV-2 virus should ensure the generation of high-titre antibodies that prevent infection. Delivering these virus targets using Scancell's DNA vaccine platform, which has already been shown to be safe and effective in cancer patients, should enable rapid translation into the clinic for prevention of COVID-19."

Professor Nigel Wright, Deputy Vice-Chancellor, Research and Innovation, at Nottingham Trent University, said:

"Nottingham Trent University and the John van Geest Cancer Research Centre are delighted to support Scancell's endeavours to develop an effective vaccine for COVID-19. These are clearly challenging times and significant progress in the development of new approaches for protecting against this virus will only be possible by collaborations such as these."

1. See notes to editors for further details about the collaboration.

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

For Further Information:

About the COVID-19 Vaccine Collaboration Members

Scancell:

Prof. Lindy Durrant has over 30 years' experience in cancer immunotherapy and clinical trials, including the Phase 1/2 SCIB1 DNA vaccine trial in melanoma and, in collaboration with Cancer Research UK, the SCIB2 DNA vaccine trial in NCSLC patients. Her team will monitor the T cell responses.

Dr. Sally Adams leads Scancell's clinical development team and has overseen the manufacture of GMP DNA vaccines/peptides and regulatory approval for their use in several First-In-Human clinical trials. She will lead the clinical development of this project.

University of Nottingham:

Dr. Janet Daly has 30 years' experience in development and testing of human and veterinary antivirals and vaccines, including human influenza DNA vaccines, and is an advisor on this project.

Dr. James Dixon is a researcher who is an expert in gene augmentation and will apply this expertise to the COVID-19 DNA vaccine.

Dr. Christopher Coleman, who is also an advisor on this project, has a wealth of experience working with human coronaviruses, including work with category 3, highly pathogenic human coronaviruses.

Prof. Jonathan Ball's group have long-standing neutralising antibody and vaccine-related research expertise and have established the platforms necessary for spike protein validation and neutralising antibody analysis, including serological and virus entry inhibition assays.

Nottingham Trent University:

Prof. Graham Pockley is Director of the John van Geest Cancer Research Centre and has over 30 years' experience in Immunobiology.

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They have the potential to be used as monotherapy or in combination with checkpoint inhibitors and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.

· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK (CRUK) for SCIB2.

Moditope® represents a completely new class of potent and selective immunotherapy agents based on stress-induced post-translational modifications (siPTM). It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat a wide variety of cancers.

· Modi-1 is being developed for the treatment of solid tumours including triple negative breast cancer, ovarian cancer and head and neck cancer.

AvidiMab™ is a patent protected technology platform which increases the avidity of human antibodies by promoting non-covalent Fc-Fc interactions. This modification induces the direct tumour cell killing properties of Scancell's anti-glycan monoclonal antibodies (mAbs) but has broad potential to increase the avidity or potency of any therapeutic monoclonal antibody including those being developed for autoimmune diseases, as well as cancer.

For further details, please see our website: www.scancell.co.uk