Empower the Immune System to Fight Cancer
Ultimovacs Company Presentation March 23, 2024
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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
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 expressed in 85-90% of cancer types across stages; represent a potential add-on treatment to CPI in multiple solid tumors
• Clinical strategy objective: Assessing UV1 efficacy across different types of cancers expressing telomerase, and where CPI therapy are (or likely to be) approved as standard-of-care
• Phase I studies with UV1 showed good safety profile and promising long-term overall survival
• UV1 + pembrolizumab in advanced melanoma: 33% complete response, ~ 70% overall survival after 4 years; similar results for PD-L1 +/- tumors
• Phase II program: Data-driven approach with five randomized controlled trials (RCT) in various indications
First randomized Phase II data in advanced mesothelioma and melanoma
• NIPU: ipi/nivo +/- UV1 in second-line treatment of malignant mesothelioma: Primary endpoint PSF not met, clinically meaningful survival improvement
• INITIUM: ipi/nivo +/- UV1, in first-line treatment of advanced melanoma: Primary/secondary endpoint not met
Near-term topline results expected from Phase II trials
• FOCUS: pembro +/- UV1 in head and neck squamous cell carcinoma: Enrollment complete, readout expected Q3 2024
• DOVACC: Second-line treatment of ovarian cancer with UV1 added to olaparib/durvalumab: Enrolling, readout expected H1 2025
Investigating UV1 across cancer indications and combinations
Indication
Combination
Phase I Single-arm trialsPhase II
Randomized controlled trialsContributors
* DOVACC and LUNGVAC Phase II trials still enrolling patients
Newsflow and milestones
UV1 VACCINE
2H 2023
2024
2025 / 2026
Malignant melanoma Phase I: UV1-103
Phase II: INITIUMMalignant pleural mesothelioma Phase II: NIPUHead and neck cancer Phase II: FOCUSOvarian cancer Phase II: DOVACCNon-small cell lung cancer Phase II: LUNGVAC
Q4: 4-yr OS Cohort 1
Q2: 4-yr OS Total
Q4: 5-yr OS Cohort 1
Data presented at ESMO, Oct 21, 2023 | Exp. topline result Q3 2024 |
Q2: 5-yr OS Total
TET TECHNOLOGY
Prostate cancer Phase I: TENDU
6
UV1 therapeutic cancer vaccine
01
The rationale for therapeutic cancer vaccination
Checkpoint inhibitor (CPI) efficacy relies on spontaneous T cell responses against cancer1
Low PD-L1 Few TILs Low IFNγ
Non-responding (cold) tumors
Vaccinate to increase the magnitude and durability of relevant T cell responses
Scarce anti-tumor T cell responses
1. Tumeh, P., Harview, C., Yearley, J. et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 515, 568-571 (2014)
Responding (hot) tumors
Abundant anti-tumor
T cell responses
High PD-L1 Many TILs High IFNγ
The UV1 vaccine induces T cell responses against telomerase
Hallmarks of cancer1
Universal
Telomerase
Characteristics
UV1 vaccine
Qualities
85-90% of tumor types express telomerase2,3
Applicable to a broad range of cancer types
Essential
Tumor cells depend on expressing telomerase
High relevance in heterogenous tumor environments
Enduring
Present throughout tumor evolution: primary to metastatic cancerEnduring and relevant immune response over time
1. Hanahan D et al. Cell (2011) - Figure created with Biorender.
2. Kim et al. Science (1994)
3. Shay et al. European Journal of Cancer (1997)
4. Hornsby PJ. (2007)
UV1 leverages the unique features of CD4 T cells
CD8 T cells
• "Soldiers" of the immune response
• Identifies target antigen on HLA class I
• Directly kill cancer cells
• "Orchestrators" of the immune response
• Identifies target antigen on HLA class II
• Promotes anti-tumor immune response through activation of:
CD4 T cells
ü CD8 T cells
ü Macrophages
ü NK cells
CD4+ T cell response towards a continuously present target maintains anti-tumor immune responses over time
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Ultimovacs ASA published this content on 25 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 March 2024 19:25:04 UTC.