SCLP Scancell Holdings Plc

Professor Lindy Durrant, Chief Executive Officer, Scancell, commented: "Scancell has made strong clinical progress, especially with its lead cancer vaccine SCIB1 for advanced melanoma. In the first stage of the Phase 2 study, 11 out of 13 patients achieved at least a partial response, exceeding the 70% ORR that the trial was configured to show. During the period, we added iSCIB1+, the next generation of SCIB1, as an additional cohort to the SCOPE trial. The addition of SCIB1 or iSCIB1+ to CPI has the potential to set the new standard for first line treatment of unresectable melanoma. We have also taken steps to strengthen our organisational capabilities and ensure readiness for a pivotal Phase 2/3 registration study in 2025. We are now well prepared and well positioned for future development."

Professor Lindy Durrant, Chief Executive Officer, and Sath Nirmalananthan, Chief Financial Officer, will host a live webcast and Q&A session for analysts and investors today at 13:00 BST.

If you would like to join the webcast, please follow this link:

Scancell Holdings PLC Full Year Results | SparkLive | LSEG

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

About Scancell

Scancell is a clinical stage immunotherapy company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate novel medicines to treat significant unmet needs in cancer. The Company is building a pipeline of innovative products by utilising its four technology platforms: Moditope^® and ImmunoBody^® for vaccines and GlyMab^® and AvidiMab^® for antibodies. Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs. The Company's approaches are that vaccines (ImmunoBody^® and Moditope^®) use unique receptors to target antigens to activated antigen presenting cells whereas its mAb portfolio targets glycans or sugars that are added onto proteins and / or lipids (GlyMab^®) or enhances the potency of antibodies and their ability to directly kill tumour cells (AvidiMab^®).

Scancell is headquartered in Oxford, United Kingdom and is listed on AIM (LSE.SCLP.L). For further information about Scancell, please visit: https://www.scancell.co.uk.

CHAIR'S STATEMENT

Immunotherapy is a growing and important treatment option for the unmet needs of cancer. Cancer vaccines are a promising class of immunotherapy designed to stimulate the body's immune system to fight against cancer, with long-lasting durable immune responses resulting in improved patient outcomes. We are developing two distinct cancer vaccines: SCIB1/iSICB1+ and Modi-1, each with unique characteristics aimed at addressing specific unmet needs in cancer treatment.

Scancell has made significant progress over the last 18 months. We have delivered impressive results with SCIB1 from the first stage of the Phase 2 SCOPE trial for advanced melanoma while strengthening our organisational capabilities and ensuring readiness for a pivotal Phase 2/3 registration study.

We were very encouraged by initial data from the ongoing SCOPE trial with 11 of the first 13 patients receiving SCIB1 in the ongoing SCOPE trial showing at least a partial response, surpassing the 70% objective response rate (ORR) that the trial was configured to show. This has the potential to set the new benchmark for first-line unresectable melanoma treatment.

In addition to the strong progress with SCIB1, we have continued the clinical development of Modi-1, including the addition of a RCC cohort with checkpoint inhibitors, and we continue to seek partners for our other assets. In June 2024, we signed an agreement with a major international biotechnology company to evaluate another antibody from the GlyMab^® platform under exclusivity, further validating the potential of our antibody platform to create novel, differentiated antibody products.

Alongside the strong development progress, we have been building and enhancing our organisational capability. We have made key hires including the recruitment of a Chief Medical Officer, a Chief Financial Officer, a Head of Business Development and a Head of Development. This leaves us well positioned and equipped as we head into a pivotal time for the company with a Phase 2/3 registration study firmly in sight.

Of course, our progress could not have been achieved without our talented employees, and I would like to thank them for their hard work and commitment. In addition, the Board would like to thank all existing shareholders, including Redmile Group, Vulpes Life Sciences, and those that participated in the fundraising in December 2023, for their support.

We strongly believe we will continue to demonstrate the therapeutic potential of SCIB1/iSCIB1+ in advanced melanoma and deliver one of the world's first off-the-shelf cancer vaccines while creating and delivering significant long-term value for our shareholders.

Jean-Michel Cosséry

Chairman

CHIEF EXECUTIVE OFFICER'S REPORT

We are pleased to report strong clinical progress in the period, especially with our lead cancer vaccine SCIB1 for the treatment of advanced melanoma.

SCIB1, our non-personalised DNA cancer vaccine from the ImmunoBody^® platform, reported exceptional results in the first stage of the SCOPE study, surpassing the target ORR of 70% with 11 out of 13 patients achieving at least a partial response. iSCIB1+, a modified version of SCIB1 which includes more melanoma-specific epitopes, has now been added as a cohort to the study and is recruiting well. The addition of SCIB1/ iSCIB1+ to checkpoint inhibitors (CPI) has the potential to improve patient outcomes for those not responding to CPI alone and set the new standard for first line treatment of unresectable melanoma. We expect full cohort data with SCIB1 and iSCIB1+ in Q4 2024 and H1 2025 respectively. Following the data, we will progress to a late-stage registration study in 2025 and evaluate partnering, out-licensing or further financing options.

Modi-1, our non-personalised citrullinated peptide vaccine from the Moditope^® platform, continues to be evaluated in the ModiFY study for the treatment of various solid tumours. A cohort in renal cell carcinoma (RCC) in combination with double CPIs has been added. Modi-1 has been shown to be safe and to induce stable disease for long periods in many patients receiving monotherapy. Further data from the study is expected in H1 2025.

Whilst we have decided to concentrate our strategic focus and resources on SCIB1/iSCIB1+ and Modi-1, we have strong confidence in our other assets. We continue to assess partnering or out-licensing options to drive these assets forward and add further value. There is strong commercial interest in our GlyMab^® antibodies with active discussions ongoing, building on our out-licensing deal with Genmab. We recently announced another agreement with an undisclosed major international biotechnology company who are exclusively evaluating another antibody from the GlyMab platform. These opportunities provide a source of potential non-dilutive funding for the company.

The financing in late 2023 raised gross proceeds of £11.9 million with participation from both existing shareholders and new healthcare specialist investors. This leaves the company funded through the data readout from the SCOPE trial and early data from the new renal cohort of the ModiFY trials. In addition, it has allowed us to enhance our organisational capabilities with key recruitments and we are well prepared and well positioned for the next phase of development.

Set out below is a summary of operational progress that has been made across our proprietary vaccine and antibody platforms. Full details of the Company's platforms and studies are available on the Company website and Annual Report.

SCIB1/iSCIB1+

SCIB1, and its next generation, iSCIB1+, are the lead non-personalised DNA cancer vaccines from the Company's ImmunoBody^® platform. They are being evaluated in the Phase 2 SCOPE trial, in combination with the checkpoint inhibitors, ipilimumab (Yervoy^®) and nivolumab (Opdivo^®), for the first-line treatment for unresectable melanoma. The doublet therapy of ipilimumab and nivolumab, is the preferred treatment option in the first line setting for unresectable melanoma. The addition of SCIB1 or iSCIB1+ to this treatment option has the potential to improve patient outcomes and set the new standard for first line treatment.  First-line unresectable melanoma impacts approximately 60,000 patients a year.

SCIB1 incorporates specific epitopes from the proteins gp100 and TRP-2 which play key roles in the production of melanin in the skin and were identified from T cells of patients who achieved spontaneous recovery from melanoma skin cancers.

iSCIB1+ is a modified version of SCIB1 developed using the company's AvidiMab^® platform. iSCIB1+ has more melanoma-specific epitopes so it can be used by a broader patient population compared with SCIB1, which is suitable for 40% of patients which have the appropriate HLA type. Furthermore, iSCIB1+ has advantages over SCIB1, including potentially increased potency and an extended patent duration.

As previously reported, the SCIB1 cohort of the SCOPE trial reported exceptional results in the first stage of the study with 11 out of 13 patients showing at least a partial response which is an objective response rate (ORR) of 85%, exceeding the 70% ORR that the trial was configured to show. This compares to an ORR of 50% reported in patients receiving doublet CPI therapy alone in the real world setting with a progression free survival time of 11.5 months.

Both the SCIB1 and iSCIB1+ cohorts are in the second stage of the study recruiting a total of 43 patients each with a study design able to demonstrate that SCIB1 or iSCIB1+, in combination with doublet therapy, exceeds currently reported ORRs with doublet CPI alone, in a statistically significant manner. There are currently 36 and 27 patients recruited in the SCIB1 and iSCIB1+ cohorts respectively. Following completion of the SCIB1 recruitment, the remaining patients with the SCIB1 HLA haplotype will be recruited to test the efficacy of iSCIB1+ in the entire patient population.

A Phase 2/3 adaptive, randomised registration study in patients with unresectable melanoma will be initiated based on the full data analysis from the SCOPE study. Plans for the Phase 2/3 registration study have been further strengthened through an international clinical advisory board comprised of melanoma key opinion leaders held at ASCO 2024.

Ahead of the registrational study, a strategic agreement with PharmaJet has been secured for use of the Stratis^® needle-free system  for delivery of SCIB1 or iSCIB1+ for melanoma for both clinical development and commercial use. The PharmaJet Stratis^® needle-free system is today the only technology which has shown effective uptake of the DNA vaccine through intramuscular delivery allowing native cellular machinery to express the target antigen and induce a potent anti-tumour response. The Stratis® system has U.S. FDA 510(k) marketing clearance, CE Mark, and World Health Organization Prequalification to deliver medications and vaccines either intramuscularly or subcutaneously and has been widely accepted and favoured by patients and clinicians throughout the SCOPE Study.

We expect full cohort data with SCIB1 and iSCIB1+ in Q4 2024 and H1 2025 respectively. Following the data, we will progress to a late stage registrational study in 2025 and evaluate partnering, out-licensing or further financing options.

SCOPE Study

The SCOPE study is an open-label, multi-cohort, multicentre Phase 2 study designed to assess whether the addition of SCIB1 or iSCIB1+ treatment to doublet CPI, considered standard of care, results in an improvement in patient outcomes for patients with metastatic advanced melanoma. The primary endpoint of the trial is objective response rate (ORR) with secondary endpoints including progression-free survival (PFS) and overall survival (OS) in patients with advanced melanoma. The trial cohorts include SCIB1 or iSCIB1+ plus doublet checkpoint therapy consisting of ipilimumab plus nivolumab and SCIB1 with pembrolizumab (Keytruda®).

MODI-1

Modi-1 is the first therapeutic vaccine candidate to emerge from the Company's Moditope^® platform.

Modi-1 targets citrullinated peptides from two different proteins which have been combined to reduce the possibility of tumour escape and have each been conjugated to a toll-like receptor (TLR) 1/2 agonist, which acts as an adjuvant.  Potent T cell responses and strong anti-tumour activity have been observed in several cancer models of different tumour types, including melanoma, ovarian, lung, pancreatic and triple negative breast cancer, following administration of the Modi-1 vaccine.

Modi-1 has completed the dose escalation and safety cohorts of the Phase 1/2 ModiFY trial and continues to be evaluated in the expansion cohorts. Clinical data from patients receiving Modi-1 as a monotherapy showed good safety and ability to induce stable disease for long periods.

The cohort of 16 ovarian cancer patients receiving Modi-1 has now been fully recruited. The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging in this difficult to treat cancer. Based on this it has been decided to evaluate Modi-1 in combination with checkpoint inhibitors, as first line therapy in advanced cancer. 

The Company is now evaluating Modi-1 in advanced renal cell carcinoma (RCC) in the first line setting. Doublet CPI is the standard of care for advanced RCC, and this trial will determine the additional efficacy benefit of Modi-1 immunisation in this most common type of kidney cancer and provide validation of the Moditope platform in combination with CPIs. The study protocol to evaluate a cohort of 44 patients received regulatory approval in May 2024 and has started enrolling patients with a preliminary read-out expected in H1 2025.

ModiFY Study

The ModiFY study is an open-label, multicohort, multicentre, adaptive Phase 1/2 trial with Modi-1 being administered alone or in combination with CPIs in patients with head and neck, triple negative breast

and renal tumours and as a monotherapy in patients with ovarian cancer, where there are no approved CPI therapies. This open label Phase 1/2 study is assessing the safety and immunogenicity of citrullinated peptides.

ANTIBODIES

The GlyMab^® platform has generated a series of high affinity tumour specific monoclonal antibodies (mAb) targeting glycans that are over-expressed on cancer cells. Supported with a robust patent portfolio and compelling proof of concept data for development as therapeutics, GlyMab antibodies support the clinical pipeline and the opportunity to generate non-dilutive revenue through partnerships with global pharma and biotech. Development under the commercial license agreement with Genmab with potential milestone payments of up to $624 million remains on track, and the GlyMab platform has been further validated through an agreement signed in June 2024 with a major international biotechnology company to exclusively evaluate another antibody in the GlyMab portfolio for $1 million.

GlyMabs offer interesting commercial opportunities as each antibody has high specificity for particular glycan molecules, making each of them attractive development candidates. In addition to being potential therapies in their own right, the specificity of the anti-glycan enables their development into a range of antibody-based therapies with differing mechanisms of action, such as antibody drug candidates, CAR-T, radioimmunotherapy and T-cell re-direction.

SC134 is the GlyMab lead asset and has strong potential as an effective therapeutic antibody for small cell lung cancer with in vivo data demonstrating anti-tumour activity as a T cell engager and an antibody drug conjugate. This data has generated broad commercial interest which will be pursued for partnership opportunities and licensing deals. Data demonstrating SC134 as effective T cell engager for small cell lung cancer has been published in a high-impact peer-reviewed international journal in August 2024.

CORPORATE

During the period, the Company has enhanced its organisational capabilities through key appointments to the Board of Directors and the Senior Management team, bringing highly relevant experience from the pharmaceutical sector to the company that will further enhance its commercial capabilities and accelerate the Company forward in achieving its strategic objectives.

Dr Florian Reinaud, Non-Executive Director, and Sath Nirmalananthan, CFO, were appointed to the Board of Directors. Dr Florian Reinaud (representing Redmile, Scancell's leading investor) brings over 20 years of executive, non-executive and financial experience from the healthcare sector. Sath Nirmalananthan has served as the Company's Chief Financial Officer since 29 August 2023 and brings more than 15 years' experience in the healthcare sector at FTSE and NASDAQ listed companies.

In July 2024, Scancell appointed Dr Nermeen Varawalla as Chief Medical Officer. She brings over 25 years of clinical development experience, including the conduct of numerous registration studies in oncology, and has worked across global large pharma, healthcare business consultancy and clinical trial services. The appointment enhances Scancell's capabilities for its Phase 2/3 registration trial following clinical results from SCIB1 and iSCIB1+ cohorts.

Other key appointments include appointing Dr Callum Scott as Head of Development and Dr Mandeep Sehmi as Head of Business Development, who both bring highly relevant pharmaceutical industry experience that will further enhance the Company's commercial capabilities as it develops to being a late-stage clinical company.

FINANCE

R&D expenditure increased by £1.3 million to £12.9 million (2023: by £2.1 million to £11.6 million). In 2024, the number of employees engaged in development increased, and we continued to incur costs for our SCOPE and ModiFY clinical trials. The most significant increase in development costs in 2024 was scaling up SCIB1 and iSCIB1+ manufacturing capabilities in preparation for the Phase 2/3 registration trial and commercialisation. The increase in R&D spend was smaller than the increase in 2023 due to prioritisation of projects with a focus on the more advanced clinical assets.

At 30 April 2024, the Group had cash and cash equivalents of £14.8 million (2023: £19.9 million). The £5.1 million decrease for 2024 was due to £17.4 million of cash used in operations, which was largely a result of continued R&D expenditure. This was offset by £11.3 million of net proceeds following an open offer and placing in December 2023. By comparison, there was an £8.8 million decrease in cash for 2023 due to continued development expenditure, which was partly offset by the revenue received from Genmab. The estimated cash runway of the Group is into the third calendar quarter of 2025. Further details of the Board's going concern assessment are provided in Note 1 to the Financial Information.