Scancell Holdings Plc · LSE:SCLP
Scancell — Proactive One2One Biotechnology Forum (November 2018)
27 slides from Scancell's conference presentation, November 2018
Slide 1: A New Frontier in Immuno-Oncology
A NEW FRONTIER IN IMMUNO-ONCOLOGY Proactive One2One Biotechnology Forum LSE: SCLP.L November 2018 A NEW FRONTIER IN IMMUNO-ONCOLOGY
Slide 2: Disclaimer
DISCLAIMER The information contained in these slides has been prepared by Scancell Holdings plc (the "Company"). It has not been approved by the United Kingdom Financial Conduct Authority under the Prospectus Rules (made under Part VI of the Financial Services and Markets Act 2000) or otherwise, or
Slide 3: Differentiated Immuno-Oncology Clinical Stage Opportunity
DIFFERENTIATED IMMUNO-ONCOLOGY CLINICAL STAGE OPPORTUNITY COMPANY • Scancell is developing innovative immunotherapies for the treatment of cancer FOCUS MARKET • Immuno-oncology is one of the fastest growing sectors in the biopharmaceutical industry (est. CAGR OPPORTUNITY ~20% over next 5 years) • No
Slide 4: Immunotherapy the 5th Pillar in the Fight Against Cancer
IMMUNOTHERAPY THE ‘5th PILLAR’ IN THE FIGHT AGAINST CANCER Cells #GOBOLDLY “This is not a video game” - US TV ad showcases the destruction of a cancer cell by immune system A NEW FRONTIER IN IMMUNO-ONCOLOGY 4
Slide 5: Immunotherapeutic Approaches to Cancer
IMMUNOTHERPAPEUTIC APPROACHES TO CANCER Harnessing the immune system to address the unmet need in improved cancer survival A NEW FRONTIER IN IMMUNO-ONCOLOGY 5
Slide 6: Immune Checkpoint Blockade
IMMUNE CHECKPOINT BLOCKADE 2018 Nobel Prize in Physiology or Medicine awarded to immunologists James Allison and Tasuku Honjo A NEW FRONTIER IN IMMUNO-ONCOLOGY 6
Slide 7: Cancer Immunotherapy Market
CANCER IMMUNOTHERAPY MARKET $34Bn A NEW FRONTIER IN IMMUNO-ONCOLOGY 7
Slide 8: Potential Value Drivers for Scancell Immunotherapies
POTENTIAL VALUE DRIVERS FOR SCANCELL IMMUNOTHERAPIES IMMUNOBODY and MODITOPE • Do not increase Big Pharma seeking novel toxicity drugs in combinations that: • Do not significantly increase overall cost of treatment • Address the unmet needs in hard to treat cancers • Provide an Drugs or combinations
Slide 9: Meeting the Need for Effective Therapeutic Cancer Vaccines
MEETING THE NEED FOR EFFECTIVE THERAPEUTIC CANCER VACCINES Key challenge is to stimulate an effective T cell response to reject or kill the growing tumour Most vaccine strategies only stimulate low frequency, low avidity T cell responses that fail to control tumour growth Scancell’s novel ther
Slide 10: Development Pipeline
DEVELOPMENT PIPELINE IMMUNOBODY® MODITOPE® SCIB1: Targets malignant melanoma. Phase 1/2 study completed with strong Modi-1: Manufacturing process development initiated. Phase 1/2 trial in survival data. Phase 2 combination trial with immune checkpoint inhibitor TNBC, ovarian and sarcoma planned
Slide 11: The Moditope Platform
THE MODITOPE® PLATFORM Stress-Induced Post-translational Modifications siPTM ► One such modification involves the process of CITRULLINATION ► The alteration of proteins due to enzymatic conversion of arginine residues to citrulline ► Citrullination occurs as a result of a degradation and ‘recycling’
Slide 12: Moditope Lead Candidate Modi-1
MODITOPE® LEAD CANDIDATE Modi-1 Consists of: Two citrullinated vimentin peptides (Vim-1 and Vim-2) One citrullinated enolase peptide (Eno-1) Vimentin and enolase targets are highly expressed in triple negative breast cancer (TNBC) (90%), ovarian cancer (95%), and sarcoma (100%) - all with hi
Slide 13: Modi-1 First in Human Study
MODI-1 FIRST IN HUMAN STUDY PATIENT POPULATION ► Patients with tumours with high vimentin or enolase expression (e.g., sarcoma, triple negative breast cancer, ovarian) ► Failed or intolerant to standard of care therapies EXPANSION PHASE n Sarcoma DOSE ESCALATION Dosing regime n Dose escalation: 10,
Slide 14: Moditope TCR Research Collaboration
MODITOPE® TCR RESEARCH COLLABORATION T cells infused ADVANTAGES OF CITRULLINATED & into cancer HOMOCITRULLINATED ANTIGEN-SPECIFIC TCRS patient Citrullinated & homocitrullinated antigens are expressed by a wide range of tumours Citrullinated & homocitrullinated antigen-specific T cells recognise
Slide 15: Moditope Milestones
MODITOPE MILESTONES EXTERNAL VALIDATION OF MODITOPE® PLATFORM INTERNAL PROJECTS ADVANCED AND EXPANDED MODITOPE® Research collaboration to develop T-cell based therapies established with BioNTech License agreed with ISA Pharmaceuticals for development of Amplivant® Modi-1 conjugate therapy GMP
Slide 16: The ImmunoBody Platform
THE IMMUNOBODY® PLATFORM Proprietary patent protected platform Several cancer associated T cell epitopes are engineered into a human antibody framework to make a genetic antigen/antibody complex Delivered as a DNA plasmid using electroporation SCIB DNA Cancer antigen sequences Vector inserted
Slide 17: SCIB1 in Patients with Melanoma
SCIB1 IN PATIENTS WITH MELANOMA SCIB1 has an excellent safety profile with no dose-limiting SURVIVAL IN RESECTED PATIENTS toxicities and no serious adverse events related to study drug or delivery device Overall survival with SCIB1 treatment superior to historical survival rates TUMOUR RESPONSE
Slide 18: SCIB1 in Melanoma Patients
SCIB1 IN MELANOMA PATIENTS PATIENTS WITHOUT TUMOUR PRESENT AT STUDY ENTRY Study entry 5 years Disease-free patients Patients with recurrence Deceased patients SCIB1 dose (2/4 mg) Disease recurrence Death Surgery Radiotherapy Electrochemotherapy Ipilimumab Nivolumab Pembrolizumab -60 -50 -40 -30 -20
Slide 19: SCIB1 Boosts Immune Checkpoint Therapy
SCIB1 BOOSTS IMMUNE CHECKPOINT THERAPY IN A MOUSE MELANOMA MODEL, SURVIVAL RATES WERE SIGNIFICANTLY BOOSTED WHEN ANTI-PD-1 THERAPY WAS COMBINED WITH SCIB1 TREATMENT Survival rates for SCIB1 ImmunoBody® monotherapy ≈ anti-PD-1 Monotherapy viable option for resected melanoma patients Combination
Slide 20: SCIB1 Plus Checkpoint Inhibitor Combination Phase 2 Study Design
SCIB1 PLUS CHECKPOINT INHIBITOR COMBINATION PHASE 2 STUDY DESIGN PATIENT POPULATION Histologically confirmed, unresectable AJCC stage III or stage IV melanoma No prior systemic treatment for advanced disease Suitable for treatment with Keytruda (pembrolizumab), with measurable disease Part 1
Slide 21: SCIB1 IND Review Process
SCIB1 IND REVIEW PROCESS ► IND submitted ü ► Reviewed by FDA ► SCIB1 clinical and toxicology questions answered during review process ü ► CMC questions under control ü ► Ichor TriGrid v2.0 device Master File ► Device-specific questions ► Responses being prepared by Ichor in consultation with Scancel
Slide 22: Commercial Success in the Oncology Market
COMMERCIAL SUCCESS IN THE ONCOLOGY MARKET • First or best-in-class • Expanding into additional • Impact on survival and cancer types fulfillment of unmet • Good market needs access/supply chain • Moving toward the earlier disease setting within • Well-tolerated safety • Unprecedented efficacy: each
Slide 23: Identified Opportunities in a Range of Treatment Settings
IDENTIFIED OPPORTUNITIES IN A RANGE OF TREATMENT SETTINGS IMMUNOBODY® MODITOPE® SCIB1 Modi-1 & Modi-2 In combination with checkpoint inhibitors in patients with late stage disease to increase efficacy without siPTM vaccine class compromising safety As monotherapy in patients with resected dise
Slide 24: Highlights for FY17/18
HIGHLIGHTS FOR FY17/18 Operational Financial SCIB2 clinical development partnership with Cancer Cash at bank on 30th April 2018 was £10,303,168 (2017: Research UK (CRUK)-December 2017 £2,672.335) Moditope research Collaboration with BioNTech to develop T- Overall loss for the year £4,194,509
Slide 25: Anticipated Newsflow + Milestones CY19
ANTICIPATED NEWSFLOW + MILESTONES CY19 IMMUNOBODY® MODITOPE® SCIB1 Modi-1 SCIB1/checkpoint inhibitor Phase 2 US/UK Preparation for the First-In-Human study with Modi-1 combination study in late stage melanoma, planned to in patients with TNBC, ovarian cancer and sarcoma start 1H19, subject to re
Slide 26: Future Value Drivers
FUTURE VALUE DRIVERS 2 PLATFORMS, 4 LEAD PRODUCTS + 5 CORE ACTIVITIES • Generate meaningful clinical data to address unmet needs: clinical read-outs (SCIB1 CLINICAL DATA Phase 2 & Modi-1 Phase1/2 pt 1) anticipated in next 2 years • Extend utility of Moditope platform beyond Modi-1 and Modi-2 in asso
Slide 27: Contact
Contact Dr. Cliff Holloway, CEO Email: cliffholloway@scancell.co.uk A NEW FRONTIER IN IMMUNO-ONCOLOGY 27 27
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