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.