Scancell Holdings Regulatory News (SCLP)

03 February 2021

Scancell Holdings plc

("Scancell" or the "Company")

Update on SCIB2 clinical development partnership

Scancell and Cancer Research UK to end clinical development partnership for SCIB2

Scancell Holdings plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces an update on its SCIB2 clinical development partnership with Cancer Research UK, a world leading cancer charity dedicated to saving lives through research. Due to the impact of the COVID-19 pandemic and Cancer Research UK's Centre for Drug Development's re-evaluation of their collaboration model, the parties have come to a mutual agreement to end their clinical development partnership for the Company's ImmunoBody® vaccine, SCIB2, for the treatment of patients with solid tumours.

Under the terms of the partnership established in December 2017, Cancer Research UK were due to fund and sponsor a UK-based Phase 1/2 clinical trial of SCIB2 in combination with a checkpoint inhibitor in patients with solid tumours. SCIB2 product rights will now revert to Scancell with no further commercial obligations to Cancer Research UK and as a result, the Company will now explore options to advance the programme either in house or with another partner.

Scancell's ImmunoBody® immunotherapy platform activates the body's immune system by enhancing the uptake and presentation of cancer antigens to help target and eliminate cancer cells. SCIB2, Scancell's second ImmunoBody® therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including NSCLC and oesophageal, ovarian, bladder and prostate cancers, as well as neuroblastoma, melanoma and sarcoma. Scancell's studies have demonstrated that administration of SCIB2 DNA payload as a liposomal nanoparticle results in potent immune responses and anti-tumour activity in preclinical models. Recent studies have demonstrated that Scancell's AvidiMab™ technology can be applied to an ImmunoBody® to increase the potency of the T cell response; this modification could be applied to SCIB2 to further enhance the responses induced and extend the patent protection on the product.

Dr Cliff Holloway, Chief Executive Officer of Scancell, commented:

"We have enjoyed working with the team at Cancer Research UK but will now explore further options to advance the SCIB2 programme which we believe has the potential to provide a much-needed treatment option for patients suffering from a range of common solid tumours."

- ENDS -

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

For Further Information:

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 (as reported in February 2018).

· 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. The Company continues to progress the Modi-1 Phase 1/2 clinical trial for regulatory submission to start the planned clinical study in the UK in the first half of 2021.

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.