Scancell Holdings Regulatory News (SCLP)

17 August 2021

Scancell Holdings plc

("Scancell" or the "Company")

Scancell selects PharmaJet's clinically proven Needle-free Systems for COVID-19 vaccine trial

Preclinical studies confirm that PharmaJet delivery of COVIDITY vaccines induces potent immune responses against both S and N antigens

PharmaJet delivery improves both the patient and caregiver experience, reducing vaccine hesitancy

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that it has selected the PharmaJet Needle-free Injection Systems to administer its two SARS-CoV-2 vaccine candidates, SCOV1 and SCOV2, in its COVIDITY Phase 1 clinical trial (COVIDITY-001). SCOV1 and SCOV2 will be administered either via an intradermal injection using the PharmaJet Tropis® Needle-free Injection System or via intramuscular delivery using the PharmaJet Stratis® system. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and World Health Organization (WHO) Performance, Quality and Safety (PQS) certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. The PharmaJet Systems are the first and only needle-free devices pre-qualified by the WHO.

As announced on 29 July 2021, the Company's COVIDITY-001 study, including the use of the two PharmaJet injectors, has been approved by the South African regulatory authority. 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.

Needle-free injectors use a narrow stream of fluid to penetrate the skin, delivering vaccines and other pharmaceuticals to the required tissue depth. Both the PharmaJet systems have been clinically proven with a wide range of vaccines, including the delivery of DNA products. These injection systems are easy to use, eliminate needlestick injuries and have the potential to expand vaccine coverage to subjects with a fear of needles. Scancell's preclinical studies have confirmed that PharmaJet delivery of its COVIDITY vaccines induces potent immune responses against both S and N antigens.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Our preclinical studies have shown that delivery of SCOV1 and SCOV2 with the PharmaJet Needle-free Systems generate excellent T cell and antibody responses. In addition, they are easy to use and ideal for people who are needle phobic, an important cause of vaccine hesitancy. We look forward to progressing our COVIDITY-001 study in South Africa and updating the market in due course."

Chris Cappello, President and CEO, PharmaJet, commented: "We are pleased to be collaborating with Scancell as they start their clinical trials with this innovative vaccine approach. Our Needle-free Systems are proven to improve the immune response for multiple DNA and RNA vaccines as well as being widely used to deliver vaccines for diseases such as influenza, measles and polio."

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.

· SCIB1, Scancell's lead product, is being developed for the treatment of metastatic melanoma. In a Phase 1/2 clinical trial, survival with SCIB1 treatment appears superior to historical survival rates, with 14 of 16 resected patients receiving 2-4 mg doses of SCIB1 surviving for more than five years.

· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours.

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. Previous pre-clinical studies have demonstrated that conjugation of these Moditope® peptides to Amplivant® enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour recurrence.

· Modi-1 consists of two citrullinated vimentin peptides and one citrullinated enolase peptide each conjugated to Amplivant®. Vimentin and enolase peptides are highly expressed in triple negative breast, ovarian, head and neck, and renal cancer, as well as many other cancers.

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 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.

About PharmaJet

PharmaJet's mission is to improve people's lives through needle-free technology. The PharmaJet Needle-free Systems are safe, fast, and easy-to-use. They eliminate needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal.

For more information visit www.pharmajet.com.