Scancell Holdings Plc · LSE:SCLP
Scancell — Proactive One2One Investor Forum (April 2019)
27 slides from Scancell's conference presentation, Apr 25, 2019
Slide 1: A New Frontier in Immuno-Oncology
A NEW FRONTIER IN IMMUNO-ONCOLOGY Proactive One2One Investor Forum, 25th April 2019 LSE: SCLP.L 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 ~30% over next 5 years) ► No
Slide 4: 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 4
Slide 5: 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 5
Slide 6: Cancer Immunotherapy Market
CANCER IMMUNOTHERAPY MARKET $34Bn A NEW FRONTIER IN IMMUNO-ONCOLOGY 6
Slide 7: Potential Value Drivers for Scancell Immunotherapies
POTENTIAL VALUE DRIVERS FOR SCANCELL IMMUNOTHERAPIES IMMUNOBODY and MODITOPE ► Do not increase Big Pharma seeking novel toxicity drugs or drug-drug ► Do not significantly combinations that: increase overall cost of treatment ► Address the unmet needs in hard to treat cancers ► Provide an increased a
Slide 8: 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 9: Development Pipeline
DEVELOPMENT PIPELINE IMMUNOBODY® MODITOPE® SCIB1: Targets malignant melanoma. Phase 1/2 study completed with strong Modi-1: Manufacturing process development on track. Phase 1/2 trial survival data. Phase 2 trial in patients receiving immune checkpoint inhibitor including TNBC, ovarian, and head
Slide 10: The Moditope Platform
THE MODITOPE® PLATFORM Stress-Induced Post-Translational Modifications (siPTM) ► One such modification involves the process of CITRULLINATION Modi-1 ► The alteration of proteins due to enzymatic conversion of arginine residues to citrulline ► Citrullination occurs as a result of a degradation and ‘r
Slide 11: 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%), sarcoma (100%) and many other so
Slide 12: Key Development Questions
KEY DEVELOPMENT QUESTIONS ► Can we make it? ► GMP production; formulation and stability studies ► Is it safe? ► Toxicology study and first in human clinical assessment ► Does it improve patient outcome? ► Robust clinical trial design; indication and patient selection ► Clinical Advisory Board to be
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., head and neck cancer (HNSCC), triple negative breast cancer (TNBC), ovarian cancer) ► Failed or intolerant to standard of care therapies EXPANSION PHASE n HNSCC DOSE ESCALATION Dosi
Slide 14: Moditope TCR Approach
MODITOPE® TCR APPROACH 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 the non-polymo
Slide 15: Moditope Milestones
MODITOPE MILESTONES 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 production of Modi-1/Amplivant® conjugates
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 + Checkpoint Inhibitor Phase 2 Trial
SCIB1 + CHECKPOINT INHIBITOR PHASE 2 TRIAL 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 safety run-in (n=6);
Slide 21: 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 22: Immuno-Oncology Deals
IMMUNO-ONCOLOGY DEALS Source: Evaluate Pharma, Cello Health BioConsulting Analysis immuno-oncology assets/technology A NEW FRONTIER IN IMMUNO-ONCOLOGY 22
Slide 23: Commercial Advantages and Opportunities
COMMERCIAL ADVANTAGES AND OPPORTUNITIES ImmunoBody®/Moditope® vaccines T cell receptors (TCR) SCIB1 clinical data showing efficacy and safety T cells recognising siPTMs could be utilised for adoptive cell transfer Potential synergy with checkpoint inhibitors will validate the ImmunoBody® platf
Slide 24: Anticipated Newsflow + Milestones
ANTICIPATED NEWSFLOW + MILESTONES IMMUNOBODY® MODITOPE® SCIB1 Modi-1 SCIB1/checkpoint inhibitor Phase 2 US/UK study in Preparation for the First-In-Human study with Modi-1 late stage melanoma, planned to start Q219, subject in patients with TNBC, ovarian cancer and HNSCC to regulatory submission
Slide 25: SCIB1 & Modi-1 Clinical Timelines
SCIB1 & MODI-1 CLINICAL TIMELINES SCIB1-002 FIVE ALL 1-YEAR Phase 2 FIVE PATIENTS PATIENTS FOLLOW-UP Melanoma PATIENTS IN DATA DATA ALL n=25 FIRST LAST PATIENT IN PATIENT IN 2019 2020 2021 2022 Q1 Q2 Q3 Q4 Q2 Q4 Q2 Q4 Q1 Q2 Q3 Q4 MODI1-001 FIRST LAST Phase 1/2 PATIENT IN PATIENT IN Three tumour DOSE
Slide 26: Outlook
OUTLOOK 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) anticipated in next 2 years ► Extend utility of Moditope® platform beyond Modi-1 and Modi-2 in association with key
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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