Scancell Holdings PLC · LSE:SCLP
Scancell — Shareholder Meeting (November 2021)
41 slides from Scancell's shareholder meeting presentation, November 2021
Slide 1: Scancell AGM presentation November 2021
SCANCELL AGM presentation November 2021 Dr John Chiplin – Chairman Professor Lindy Durrant – CEO, CSO Dr Sally Adams – Chief Development Officer Professor Christian Ottensmeier, Clatterbridge Cancer Centre and University of Liverpool LSE: SCLP.L
Slide 2: Disclaimer
DISCLAIMER This date hereof. The presentation has not been independently verified and no representation or warranty, express or implied, is made or given by presentation has been prepared by Scancell Holdings plc (the "Company") for general information purposes only. This presentation may not be cop
Slide 3: Disclaimer cont'd
DISCLAIMER CONT’D The financial information contained in this presentation is based on publicly available historic financial information of the Company and is not intended to be a profit forecast or profit estimate under applicable rules. Due to rounding, numbers presented throughout this presentati
Slide 4: Dr John Chiplin, Chairman
Dr John Chiplin Chairman HARNESSING IMMUNOLOGY TO FIGHT DISEASE 4
Slide 5: Strong progress during transformative period
STRONG PROGRESS DURING TRANSFORMATIVE PERIOD FINANCIAL YEAR ENDED 30 APRIL 2021 & POST-PERIOD Financials ► Raised £48m (£46.1m net) and welcomed Redmile Group as largest shareholder Moditope® ► Modi-1 CTA approved with First-in-Human clinical trial in multiple solid tumours to start before end of 20
Slide 6: Summary financials
SUMMARY FINANCIALS Audited Financials Share Capital £’000, 30 April Y/E 2019 2020 2021 Shares in Issue Significant Shareholders Development (4,152) (4,667) (6,406) Administrative (2,557) (2,115) (3,346) 29.66% Shares outstanding: Grant income 0 0 918 815,218,831 Operating loss (6,729) (6,782) (8,834
Slide 7: Professor Lindy Durrant, Chief Executive Officer
Professor Lindy Durrant Chief Executive Officer HARNESSING IMMUNOLOGY TO FIGHT DISEASE 7
Slide 8: Scancell: at the forefront of clinical immunology
SCANCELL: AT THE FOREFRONT OF CLINICAL IMMUNOLOGY VISION VACCINES ANTIBODIES Stimulate potent killer T cells Monoclonal antibodies used to target tumours Improve patient outcomes and MODITOPE® TaG mAbs shareholder value Modi-1: Citrullination Phase 1/2 trial in breast, ovarian, renal and head & neck
Slide 9: Overview of pipeline & key upcoming events
OVERVIEW OF PIPELINE & KEY UPCOMING EVENTS LeadCandidates Lead candidates Preclinical Clinical KEY UPCOMING EVENTS VACCINES Modi-1 Safety and immunological data: H1 2022 Triple negative breast, ovarian, renal, head & neck Efficacy data: 2022 - 2023 Modi-2 Preclinical development: Ongoing Multiple so
Slide 10: Vaccines: modified-peptide & DNA technologies drive potent T-cell responses
VACCINES: MODIFIED-PEPTIDE & DNA TECHNOLOGIES DRIVE POTENT T-CELL RESPONSES ► Two modified-peptide cancer vaccines based on proprietary MODITOPE® technology ► Multiple clinical stage DNA vaccines for cancer and infectious disease MODIFIED PEPTIDE VACCINES DNA VACCINES MODITOPE® COVIDITY™ IMMUNOBODY®
Slide 11: Modi-1 vaccine is effective against advanced tumours
MODI-1 VACCINE IS EFFECTIVE AGAINST ADVANCED TUMOURS ► B16cDR4 tumours established in HLA-DR4 transgenic mice (d1) ► B16iDP4 tumours established in DP4 transgenic mice (d1) ► Modi-1v peptides plus adjuvant administered on d7, d10 or d14 ► Modi-1 peptides plus adjuvant administered when tumours reach
Slide 12: MHRA-approved Modi-1 clinical trial design
MHRA-APPROVED MODI-1 CLINICAL TRIAL DESIGN HARNESSING IMMUNOLOGY TO FIGHT DISEASE 13
Slide 13: SCIB1 Phase 2 trial in melanoma
SCIB1 PHASE 2 TRIAL IN MELANOMA SCIB1 IN COMBINATION WITH CHECKPOINT INHIBITOR KEYTRUDA FOR THE TREATMENT OF METASTATIC MELANOMA ► Trial rationale based on excellent 5-year survival data in Phase 1/2 trial in resected late-stage patients ► Patient recruitment impacted by ► Ongoing COVID-19 pandemic
Slide 14: COVIDITY – a second generation vaccine for COVID-19
COVIDITY – A SECOND GENERATION VACCINE FOR COVID-19 A DIFFERENTIATED COVID-19 VACCINE ADAPTED FROM IMMUNOBODY® DNA APPROACH Targeting two SARS-CoV-2 viral antigens ► SARS-CoV-2 nucleocapsid protein (N-protein) ► SARS-CoV-2 spike protein (S-protein) ► Targets the S protein to induce VNAbs that preven
Slide 15: COVIDITY – Phase 1 trial design
COVIDITY – PHASE 1 TRIAL DESIGN Phase 1 First-in-Human open-label study to assess the safety, tolerability and immunogenicity of SCOV1 and SCOV2 vaccines administered by needle-free injection in pre-vaccinated (UK) and naïve healthy adults (South Africa) South Africa Phase 1 UK Phase 1 HARNESSING IM
Slide 16: Antibodies – unlocking the value of TaGs
ANTIBODIES – UNLOCKING THE VALUE OF TaGS ► Glycans are post-transcriptional modifications which are ► Robust pipeline with five mAb candidates highly dysregulated in cancer making them excellent ► Four anti-TAG antibodies targeting a range of cancers tumour selective targets ► One T-cell targeting a
Slide 17: Each TaG is a platform
POTENTIAL FOR EACH ANTIBODY TO BE DEVELOPED INTO MULTIPLE PRODUCTS radionucleotide Int J Mol Sci 2016;17:561 Radioimmunotherapy Leukemia & Lymphoma 2018;59(8):1785 Antibody drug conjugates Chimeric antigen receptors (CAR) Expression of same glycan on multiple proteins and lipids allows the same anti
Slide 18: Market potential for ADCs
MARKET POTENTIAL FOR ADCs Approvals of Antibody-Drug Conjugates have picked up... ADC market is estimated to be valued at US$4.29B in 2021 and is expected to surpass US$ 11.01B, globally, by end of 2028 at a 2000 2010 2021 compound annual growth rate of 14% …with many more ADCs in clinical developme
Slide 19: Marketed immuno-oncology product & pipeline products
MARKETED IMMUNO-ONCOLOGY PRODUCT & PIPELINE PRODUCTS Number, type & phase of pipeline products Marketed immuno-oncology products Key metrics in the seven major pharmaceutical markets (7MM) Source: GlobalData, Pharma Intelligence Center [December 2020] HARNESSING IMMUNOLOGY TO FIGHT DISEASE 20
Slide 20: Market analysis & forecast
MARKET ANALYSIS & FORECAST SC129, SC88, SC134, SC27 Modi-1, Modi-2, iSCIB1+, iSCIB2 SC129, SC88, SC134, SC27 SC2811 Sales of products that comprise the five classes of IO are forecast to reach over $95B by 2020 Source: GlobalData, Pharma Intelligence Centre – Consensus Analyst Forecasts [December 20
Slide 21: Scancell: at the forefront of clinical immunology
SCANCELL: AT THE FOREFRONT OF CLINICAL IMMUNOLOGY ► Three innovative proprietary platforms: Moditope®, ImmunoBody® and AvidiMab™ CLINICAL IMMUNOLOGY PLATFORMS 1 GENERATING PRODUCT CANDIDATES ► Delivering highly promising vaccines & antibody products for oncology & infectious diseases ► Validation vi
Slide 22: Vision: creating value for the future – four progress areas
CREATING VALUE FOR THE FUTURE – FOUR PROGRESS AREAS Strengthen and build the clinical team and KOL networks 1 CLINICAL DATA Drive the maximum number of products into the clinic and generate meaningful clinical data SCIB1, COVIDITY & Modi-1 Phase 1/2 interim data expected within next 18 months Extend
Slide 23: Dr Sally Adams, Chief Development Officer
Dr Sally Adams Chief Development Officer HARNESSING IMMUNOLOGY TO FIGHT DISEASE 24
Slide 24: Modi-1 development update: manufacturing
MODI-1 DEVELOPMENT UPDATE MODI-1 MANUFACTURING ► Modi-1 conjugates Modi-1v ► Vim28 + Vim415 + Eno241 ► Hydrophobic peptide conjugates ► Challenging synthetic properties ► Manufacturing process for all conjugates developed; some supply chain issues ► First-in-Human study ► Novel, cutting edge product
Slide 25: Modi-1 development update: clinical trial
MODI-1 DEVELOPMENT UPDATE MODI-1-001 CLINICAL TRIAL REGULATORY APPROVALS ► MHRA Scientific Advice meeting and follow up discussions ► Start of trial impacted by pandemic; focus on COVID-19 trials ► Investigational Medicinal Product Dossiers and protocol submitted ► Approval for first in human clinic
Slide 26: MHRA-approved Modi-1 clinical trial design
MHRA-APPROVED MODI-1 CLINICAL TRIAL DESIGN HARNESSING IMMUNOLOGY TO FIGHT DISEASE 27
Slide 27: COVIDITY – a second generation vaccine for COVID-19
COVIDITY – A SECOND GENERATION VACCINE FOR COVID-19 RAPID ACCELERATION FROM RESEARCH TO CLINIC ► Drug Product is plasmid DNA based on ImmunoBody platform ► ImmunoBody SCIB1 used safely in Phase 1/2 melanoma clinical trial ► Rapid progression of pVaxDCSN to clinic ► Reduced preclinical toxicity testi
Slide 28: COVIDITY – manufacturing timeline 2021
COVIDITY – MANUFACTURING TIMELINE 2021 FIRST SUBJECT SCOV1 drug SCOV1 shipped DOSED product vialled to South Africa Selection of SCOV1 bulk drug SCOV1 SCOV1 released pSN15 (SCOV1) manufactured potency assay for clinic J F M A M J J A S O N D Selection of SCOV2 SCOV2 bulk drug SCOV2 drug SCOV2 releas
Slide 29: COVIDITY – clinical timeline 2021
COVIDITY – CLINICAL TIMELINE 2021 FIRST Cape Town Site SUBJECT selected activated DOSED Vaccine naïve in Ethics South Africa SAPHRA approval approval J F M A M J J A S O N D Synexa selection Assay Synexa audit for T cell assays qualification MHRA Scientific MHRA follow-up Advice trial design HARNESS
Slide 30: COVIDITY – Phase 1 trial design
COVIDITY – PHASE 1 TRIAL DESIGN Phase 1 First-in-Human open-label study to assess the safety, tolerability and immunogenicity of SCOV1 and SCOV2 vaccines administered by needle-free injection in pre-vaccinated (UK) and naïve healthy adults (South Africa) South Africa Phase 1 UK Phase 1 HARNESSING IM
Slide 31: Research to clinic timelines
RESEARCH TO CLINIC TIMELINES ► COVIDITY programme demonstrates potential for improvement of development timelines ► Existing ImmunoBody safety data removed need for further toxicity testing ► Regulatory approval timelines shortened for all COVID-19 products ► Outsourcing of all drug manufacturing pr
Slide 32: Bellhouse Building – the Oxford Science Park
BELLHOUSE BUILDING – THE OXFORD SCIENCE PARK ► Functional areas for expansion ► Clinical ► Translational Research ► Formulation Development ► Quality ► The Oxford Science Park ► Oxford is one of the UK’s leading centres for Research & Development ► Excellent local talent pool for recruitment ► World
Slide 33: Modi-1 clinical trial
MODI-1 Clinical trial Professor Christian Ottensmeier Clatterbridge Cancer Centre and University of Liverpool LSE: SCLP.L
Slide 34: Modi-1: meeting unmet clinical needs
MODI-1: MEETING UNMET CLINICAL NEEDS Global burden of head & neck, ovarian, triple negative breast and renal cell cancers combined is substantial, with over 0.75 million deaths worldwide attributable in 20181 HEAD & NECK CANCER ► Head & neck cancers represent the 6th leading cancer group by incidenc
Slide 35: Squamous cell carcinoma of the head & neck
SQUAMOUS CELL CARCINOMA OF THE HEAD & NECK CURRENT THERAPIES ► A total of over 650,000 new cases and 330,000 deaths are recorded each year ► Squamous cell carcinoma of the head & neck (SCCNN) generally begins in the mucosal surfaces of the head and neck region, with the most frequent tumour sites be
Slide 36: Principal investigator for Modi-1 trial – why?
PRINCIPAL INVESTIGATOR FOR MODI-1 TRIAL – WHY? MODI-1 HAS POTENTIAL TO BE A GAME-CHANGER FOR CANCER PATIENTS ► Highly mutating tumours stimulate T cells, but these are switched off in the immunosuppressive tumour environment ► Checkpoint inhibitors can reinvigorate these T cells BUT most tumours do
Slide 37: MHRA-approved Modi-1 clinical trial design
MHRA-APPROVED MODI-1 CLINICAL TRIAL DESIGN HARNESSING IMMUNOLOGY TO FIGHT DISEASE 5
Slide 38: Neoadjuvant cohort
NEOADJUVANT COHORT Randomized, neoadjuvant cohort in patients with SCHNN aims to assess the effect of Modi-1, alone or in combination with a checkpoint inhibitor, in promoting T-cell infiltration into the tumour Formalin-fixed, Histology paraffin- embedded Tumour (FFPE) sections Immunohistochemistry
Slide 39: A comprehensive translational programme
A comprehensive translational programme BASELINE POST ICI TREATMENT Immune cell populations Immune cell populations (TRM CD8) (TRM CD8) Flow Molecular biomarkers PAIRWISE & cytomety of RESPONSE cancer tissue cancer tissue GROUPWISE RNA-Seq Molecular biomarker DATA analysis of FAILURE IHC Matched Mat
Slide 40: What will the clinical trial tell us?
WHAT WILL THE CLINICAL TRIAL TELL US? ► Does Modi-1 stimulate T cell responses in cancer patients? ► Do these T cells remain active within the tumour? ► Does the tumour regress? ► What biomarker predicts response? ► Which is the most relevant cohort to expand further? HARNESSING IMMUNOLOGY TO FIGHT
Slide 41: www.scancell.co.uk
www.scancell.co.uk HARNESSING IMMUNOLOGY TO FIGHT DISEASE 34
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