Zelluna ASA · OSL:ZLNA
Zelluna ASA — Ultimovacs — Investor Presentation (May 2024)
39 slides from Zelluna ASA's investor presentation, May 7, 2024
Slide 1: Empower the Immune System to Fight Cancer
Empower the Immune System to Fight Cancer Ultimovacs Company Presentation May 07, 2024
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Ultimovacs ASA (“Ultimovacs” or the expressed or implied by the forward-looking statements contained in this “Company”) for information purposes only and does not constitute an offer to presentation. Given these risks, uncertainties and other factors
Slide 3: Contents
Contents 01 UV1: therapeutic cancer vaccine 02 Phase I results 03 Phase II strategy and clinical trials 04 Discovery: TET technology 05 Outlook and opportunities 3
Slide 4: UV1: An off-the-shelf cancer vaccine in a broad clinical program
INTRODUCTION UV1: An off-the-shelf cancer vaccine in a broad clinical program • Immune checkpoint inhibitors (CPI) have transformed cancer treatment, but the success rate varies • Cancer vaccines can enhance the activation and infiltration of T cells into the tumor • UV1 target telomerase is express
Slide 5: Investigating UV1 across cancer indications and combinations
INTRODUCTION Investigating UV1 across cancer indications and combinations Phase II Phase I Indication Combination Randomized Contributors Single-arm trials controlled trials Malignant Ipilimumab INITIUM (N=156) melanoma Nivolumab Ultimovacs Malignant sponsored Pembrolizumab UV1-103 (N=30) melanoma t
Slide 6: Newsflow and milestones
INTRODUCTION Newsflow and milestones UV1 VACCINE 2H 2023 2024 2025 / 2026 Malignant melanoma Q4: 4-yr OS Cohort 1 Q2: 4-yr OS Total Phase I: UV1-103 Topline result Phase II: INITIUM March 2024 Malignant pleural Data presented at mesothelioma ESMO, Oct 21, 2023 Phase II: NIPU Head and neck cancer Exp
Slide 7: UV1 therapeutic cancer vaccine
01 UV1 therapeutic cancer vaccine
Slide 8: The rationale for therapeutic cancer vaccination
UV1 The rationale for therapeutic cancer vaccination Checkpoint inhibitor (CPI) efficacy relies on spontaneous T cell responses against cancer1 Non-responding (cold) tumors Responding (hot) tumors Low PD-L1 Vaccinate to increase the High PD-L1 Few TILs magnitude and durability of Many TILs Low IFNγ
Slide 9: The UV1 vaccine induces T cell responses against telomerase
UV1 The UV1 vaccine induces T cell responses against telomerase Hallmarks of cancer1 Telomerase UV1 vaccine Characteristics Qualities 85-90% of tumor types express Applicable to a broad range of Universal telomerase2,3 cancer types High relevance in heterogenous Tumor cells depend on expressing Esse
Slide 10: UV1 leverages the unique features of CD4 T cells
UV1 UV1 leverages the unique features of CD4 T cells CD8 T cells CD4 T cells • “Soldiers” of the immune response • “Orchestrators” of the immune response • Identifies target antigen on HLA class I • Identifies target antigen on HLA class II • Directly kill cancer cells • Promotes anti-tumor immune r
Slide 11: Mode of action & downstream mechanisms enhance tumor killing
UV1 Mode of action & downstream mechanisms enhance tumor killing Intradermal injection of UV1 and 1 activation of TERT-specific T cells 1 Improved priming of anti-tumor immune 2 responses • T cells bind their antigen (TERT) expressed on local APCs and the T cells release cytokines (TNF-α, IFN-γ and
Slide 12: Rationale behind different combination approaches
UV1 Rationale behind different combination approaches Anti-CTLA-4 and PD-1 Anti-PD-1/L1 INITIUM and NIPU trials FOCUS, DOVACC, and LUNGVAC trials • Most effective SoC immunotherapy in immunogenic • Widely established SoC in multiple indications (>35) solid tumors • Lack of anti-tumor T cell response
Slide 13: Demonstrated good safety across the trials
UV1 Demonstrated good safety across the trials • UV1 does not inhibit telomerase activity but generates T cell responses recognizing fragments of telomerase presented in the context of HLA molecules on cells in the tumor • No safety signals seen from healthy tissues expressing telomerase (e.g. stem
Slide 14: The UV1 vaccine is off-the-shelf and easy to administer
UV1 The UV1 vaccine is off-the-shelf and easy to administer Peptide selection strategy Off-the-shelf treatment Selected based on strong immuno- Peptides are promiscuous with genicity and correlation to pro- respect to HLA class I and II longed survival in human trials alleles Active ingredients Thre
Slide 15: Phase I results
@ultimovacs O02 Phase | results
Slide 16: UV1 plus pembrolizumab in advanced melanoma
PHASE 1 UV1-103 TRIAL UV1 plus pembrolizumab in advanced melanoma Sponsor: Ultimovacs Country: USA 1L treatment of advanced melanoma N=30 • Advanced histologically confirmed UV1 Primary endpoint: malignant melanoma (stage IIIB-C, IV) Pembrolizumab • Safety • Measurable and evaluable disease Cohort 1
Slide 17: Sustained long-term overall survival after 48 months
PHASE 1 UV1-103 TRIAL IN ADVANCED MELANOMA Sustained long-term overall survival after 48 months Progression free survival: Overall survival: • Median PFS 18.9 months (95% CI, 3.5–NR) • Median follow-up 47.8 months • Median OS not reached (95% CI, 31.2-NR) Progression-free Survival (n=30) Overall Sur
Slide 18: Sustained high ORR and CR rate also in PD-L1 negative tumors
PHASE 1 UV1-103 TRIAL IN ADVANCED MELANOMA Sustained high ORR and CR rate also in PD-L1 negative tumors Responses lasting up to 2 years (max. follow-up) Best overall n % response (iRECIST) ORR (n=30) 17 56.7 Complete response 10 33.3 Partial response 7 23.3 Stable disease 2 6.7 Progressive disease 1
Slide 19: Phase II strategy and clinical trials
03 Phase II strategy and clinical trials
Slide 20: Wide-ranging randomized controlled Phase II clinical program
Wide-ranging randomized controlled Phase II clinical program NIPU INITIUM FOCUS DOVACC LUNGVAC Second line First line malignant First line head and Second line ovarian First line non-small Indication mesothelioma melanoma neck cancer cancer cell lung cancer Immunotherapy Ipilimumab Ipilimumab Durval
Slide 21: NIPU: Second-line malignant pleural mesothelioma
NIPU: Second-line malignant pleural mesothelioma Sponsor: Oslo University Hospital Contributors: BMS, Ultimovacs Sites and countries: Six hospitals in Norway, Sweden, Denmark, Spain and Australia NCT04300244 2L malignant metastatic pleural Primary endpoint: mesothelioma • Progression-free survival N
Slide 22: Encouraging survival results presented at ESMO 2023
NIPU Encouraging survival results presented at ESMO 2023 No added toxicity compared to ipi + nivo alone • Safety profile of UV1 in combination with ipi + nivo is comparable to that of ipi + nivo alone Primary endpoint progression-free survival not met • Main analysis of progression-free survival fai
Slide 23: INITIUM: First-line advanced melanoma
INITIUM: First-line advanced melanoma Sponsor: Ultimovacs Sites and countries: 39 hospitals in US, UK, Belgium and Norway NCT02275416 Primary endpoint: UV1 • Progression-free survival 1L unresectable 1L unresectable or or metastatic metastatic Ipilimumab • Blinded independent central review (BICR) m
Slide 24: Topline results reported after 18 months follow-up
INITIUM Topline results reported after 18 months follow-up No added toxicity compared to ipi + nivo alone • Safety profile of UV1 in combination with ipi + nivo is comparable to that of ipi + nivo alone Primary and secondary endpoints not met • Main analysis of progression-free survival, overall sur
Slide 25: FOCUS: First-line head and neck cancer
FOCUS: First-line head and neck cancer Sponsor: Halle University Hospital Network Contributors: Ultimovacs Sites and countries: 10 hospitals in Germany NCT05075122 Primary endpoint: UV1 • Progression-free survival rate at 6 1L head and neck cancer Pembrolizumab months (N=50) Secondary endpoints: N=7
Slide 26: DOVACC: Relapsed ovarian cancer
DOVACC: Relapsed ovarian cancer Sponsor: NSGO/ENGOT Contributors: AstraZeneca, Ultimovacs Sites and countries: 35 hospitals, 10 countries in Europe NCT04742075 High-grade BRCA negative ovarian UV1 cancer, 2L maintenance Olaparib Durvalumab Primary endpoint: N=184 (N=92) • Progression-free survival •
Slide 27: LUNGVAC: First-line non-small cell lung cancer
LUNGVAC: First-line non-small cell lung cancer Sponsor: Drammen Hospital Contributors: Ultimovacs Sites and countries: 9 hospitals in Norway NCT05344209 1L advanced or metastatic non-small cell UV1 Primary endpoint: lung cancer Cemiplimab Progression-free survival N=138 (N=69) • NSCLC stage IIIB/III
Slide 28: Discovery: TET technology
04 Discovery: TET technology
Slide 29: The TET vaccine technology
The TET vaccine technology TET (Tetanus-Epitope Targeting) is Ultimovacs’ patent The units delivering the adjuvant and the antigen protected vaccine adjuvant technology. signals are linked by use of an innovative conjugation technology. TET ensures targeted delivery of both antigen and adjuvant sign
Slide 30: Targeted delivery of the vaccine to antigen presenting cells
Targeted delivery of the vaccine to antigen presenting cells VACCINATION: IMMUNE COMPLEX: TARGETED DELIVERY: RECEPTOR CLUSTERING ACTIVATION: …and KILLING Anti-tetanus The antibodies bind The immune complex binds to prompts the dendritic cell This leads to OF THE TUMOR antibodies are to the tetanus r
Slide 31: TENDU: First clinical evaluation of a TET vaccine
TENDU: First clinical evaluation of a TET vaccine Sponsor: Ultimovacs Sites and countries: Oslo University Hospital, Norway NCT04701021 TENDU Primary endpoint: Patients with relapse after primary • Safety radical prostatectomy Dose cohort 1 (N=3) Secondary endpoints: Dose cohort 2 (N=3) N=12 Dose co
Slide 32: Other CMC and preclinical development
Other CMC and preclinical development • Ultimovacs is conducting a series of activities to further develop and explore the potential of TET and the conjugation technology • Preclinical experiments support the TET strategy of targeted delivery of antigens and adjuvant signals to antigen presenting ce
Slide 33: Outlook and opportunities
04 Outlook and opportunities
Slide 34: Investigating UV1 with the leading immune checkpoint inhibitors
OPPORTUNITIES Investigating UV1 with the leading immune checkpoint inhibitors Cancer indication CPI use % US market UV1 Approved CPIs • Immune checkpoint inhibitors (CPI) have Melanoma 80% $3.8 bn Pembrolizumab, ipilimumab, nivolumab, transformed cancer treatment the last decade, opdualag but the su
Slide 35: The benefit of off-the-shelf vs. individualized vaccines
The benefit of off-the-shelf vs. individualized vaccines Off-the-shelf Individualized Vaccine modality Shared antigen Individualized Patient screening (biopsy) Not required Required Specialized hospital infrastructure Not required Required Time to treatment Immediate ~6 weeks Limited due to Possibil
Slide 36: UV1 regulatory designations in the U.S. and the EU
UV1 regulatory designations in the U.S. and the EU Melanoma FDA Orphan Drug Designation has been granted to UV1 for treatment of stage IIB-IV melanoma (December 2021) FDA Fast Track Designation has been granted for UV1 as add-on therapy to ipilimumab or pembrolizumab for treatment of unresectable or
Slide 37: Corporate overview
Corporate overview Company profile Management Largest shareholders2 • Founded in 2011 based on more than Carlos de Sousa MD, Jens Bjørheim Investor Holding EMBA MD, PhD 30 years of research Chief Executive Chief Medical Officer Gjelsten Holding 18.9% • Listed at Euronext Oslo Stock Officer Radforsk
Slide 38: Key takeaways
Key takeaways Ultimovacs is dedicated to investigate the potential of UV1 to enhance the efficacy of cancer therapies: • UV1 has shown promising benefits in several clinical studies, inducing robust, durable, and dynamic T cell responses against telomerase - a ’Hallmark of cancer’ • Significant indi
Slide 39: Empower the Immune System to Fight Cancer
Empower the Immune System to Fight Cancer Contact: [email protected]