vididencel (DCP-001) / Mendus - LARVOL DELTA

Mendus Initiates Phase 1b DIVA Trial of Vididencel Plus Venetoclax and Azacitidine in Acute Myeloid Leukemia (OncoDaily) - "The study will focus on patients with measurable residual disease (MRD) following first-line treatment with venetoclax plus azacitidine (Ven+Aza) who are considered unsuitable for intensive induction chemotherapy. According to Mendus, preparations for the study have been completed, and all required regulatory approvals have been obtained....DIVA, short for Dendritic cell Immune activation combined with Venetoclax and Azacitidine, is a single-arm Phase 1b study expected to enroll 24 patients."

Trial status • Acute Myelogenous Leukemia

Use of an Allogeneic Leukemia-Derived Dendritic Cell Vaccine in MRD+ AML-Patients Results in MRD Conversion, Improved Relapse-Free Survival and Vaccine Induced Immune Responses to Tumor Antigens (ASH 2022) - P2 | "Relapse on study was limited, with an estimated RFS at 6 months of 83.7%, which is higher than expected for this MRD+ AML patient population, which would be around 45% as shown for placebo-treated patients from a recent phase III study in a similar patient population (Quazar AML001). Immunotherapy with DCP-001 as AML maintenance therapy is safe and effective in triggering immune responses and converting patients from MRD positive to MRD negative, leading to promising relapse-free survival."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD8 • CEBPA • IDH2 • IFNG • NPM1 • PRAME • RUNX1 • RUNX1T1 • TP53 • WT1

Induction of Cellular and Humoral Immune Responses Is Associated with Durable Remissions in MRD+ AML-Patients after Maintenance Treatment with an Allogeneic Leukemia-Derived Dendritic Cell Vaccine (ASH 2023) - P2 | "The locally skin induced immune response leading to influx of a plethora of immune cells, confirmed the mode of action of immune priming through intradermal administration of the cancer vaccine. These results warrant further studies combining vididencel with SOC such as hypomethylating agents in AML maintenance."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD4 • CD8 • CDK1 • CEBPA • IDH2 • IFNG • NPM1 • PRAME • RUNX1 • RUNX1T1 • TP53 • WT1

Significant events after the end of the reporting period (Mendus Press Release) - "Mendus announced the successful enrollment of the first stage of the VITAL-CML trial, supporting an initial readout based on safety, tolerability and early molecular responses in the second half of 2026. Mendus announced a collaboration with the South Australian Health and Medical Research Institute (SAHMRI) in preparation for the VITAL-TFR2 trial in CML. The goal of the VITAL-TFR2 trial is to assess whether vididencel can increase the likelihood of successful TFR in patients with a previously failed TFR attempt."

Licensing / partnership • P1 data • Chronic Myeloid Leukemia

Phase I Trial of Vididencel in CML-CP Patients With MRD Under TKI Treatment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Mendus

New P1 trial • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1

Vididencel, an active immunotherapy in high-grade serous ovarian carcinoma patients: Analysis of tumor-directed immune responses post-primary treatment. (ASCO 2026) - P1 | "Long-term follow-up of HGSOC patients treated with vididencel confirms safety, tolerability and feasibility resulting in strong T cell response against TAA. The improved tumor-directed responses were associated with better progression-free survival. These data confirm that vididencel is a safe immunotherapy and provides strong basis for novel combination treatments for ovarian cancer patients."

Clinical • IO biomarker • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • CTAG1B • IFNG • MAGEA3 • MUC16 • PRAME • WT1

Preclinical evaluation of an active immunotherapy, vididencel, and ABL tyrosine kinase inhibitors combination for chronic myeloid leukemia (CIMT 2026) - "Clinically relevant concentrations of imatinib, dasatinib, nilotinib, and bosutinib were used to assess direct effects on DCOne mature dendritic cell (mDC) viability and phenotype by flow cytometry. These findings highlight the need for further preclinical and clinical evaluation of TKI-vididencel interactions to inform optimal integration of immunotherapy strategies aimed at improving TFR outcomes in CML. 88"

IO biomarker • Preclinical • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • PRAME • WT1

Mendus AB…reports that it has presented preclinical data from its chronic myeloid leukemia (CML) program at the 23rd Association for Cancer Immunotherapy (CIMT) Annual Meeting (Mendus Press Release) - "The research presented at CIMT confirms that vididencel can be combined with a broad range of TKIs used for the treatment of CML and that the immune-activating properties of vididencel are unaffected by asciminib. This supports the combination of vididencel with next-generation TKIs that belong to the class of allosteric inhibitors, also called STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitors."

Preclinical • Chronic Myeloid Leukemia

ALISON: Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: University Medical Center Groningen | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion • Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

ALISON: Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Universitair Medisch Centrum Groningen | Not yet recruiting ➔ Completed | Completed ➔ Active, not recruiting

Enrollment closed • Trial completion • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Mendus AB…announced that the first patient has been enrolled in the VITAL-CML trial, which evaluates Mendus’ lead product vididencel in chronic myeloid leukemia (CML) (Mendus Press Release) - "The VITAL-CML trial will recruit up to 24 patients, with initial topline safety and early molecular response data based on the first 8 patients treated expected in the second half of 2026. If positive, this will trigger the onset of the VITAL-TFR2 Phase 2a trial to assess the role of vididencel to improve TFR rates in patients who failed an earlier TFR attempt."

P1 data • Trial status • Chronic Myeloid Leukemia

Mendus announces start of clinical program in CML (TradingView) - "Mendus has now completed preparations and received all necessary approvals to open the trial for recruitment. The primary objective of the VITAL-CML trial is to establish safety and feasibility of vididencel as an active immunotherapy in CML, with the ultimate goal to allow patients to stop their medication safely and effectively, described as ‘treatment-free remission’ (TFR)....The VITAL-CML trial will recruit up to 24 patients, with initial topline safety and early molecular response data based on the first 8 patients treated are expected in the second half of 2026. If positive, this will trigger the onset of the VITAL-TFR2 Phase 2a trial to assess the role of vididencel to improve TFR rates in patients who failed an earlier TFR attempt."

New P2a trial • P1 data • Trial status • Chronic Myeloid Leukemia

VITAL-CML: An Open-Label, Single-Arm Phase 1 Trial to Evaluate The Safety, Tolerability and Efficacy of Vididencel in Chronic Phase Chronic Myeloid Leukemia Patients with Measurable Residual Disease Unable to Meet Requirements of Treatment Free Remission under Tyrosine Kinase Inhibitor Treatment (clinicaltrialsregister.eu) - P1 | N=24 | Not yet recruiting | Sponsor: Mendus B.V.

New P1 trial • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Mendus signs agreement with Olivia Newton-John Cancer Research Institute to expand clinical development of vididencel in AML (TradingView) - "The DIVA trial will evaluate vididencel as an immunotherapy in newly diagnosed AML patients treated with venetoclax and azacitidine (Ven+Aza)...The agreement with ONJCRI marks the formal start of the DIVA trial preparations, for which ONJCRI will act as sponsor and coordinator...The Phase 1b DIVA trial will enroll 24 patients and evaluate vididencel as a post-remission immunotherapy in newly diagnosed patients with AML treated with Ven+Aza. The trial will be conducted in Australia, where Mendus operates via its local subsidiary, Mendus Australia Pty Ltd, enabling access to attractive R&D tax incentives....The DIVA trial is planned to commence mid-2026."

Commercial • New P1 trial • Acute Myelogenous Leukemia

Mendus AB Year-end Report 2025 (Mendus Press Release) - "Mendus will also develop vididencel in chronic myeloid leukemia (CML), with two clinical trials being prepared to start in 2026."

New trial • Chronic Myeloid Leukemia

Post-remission immunotherapy with vididencel for a measurable residual disease defined high-risk sub-group of adult patients with Acute Myeloid Leukemia in first complete hematological remission: Updated results of the european advance II study demonstrate robust safety, relapse-free and overall survival benefit. (ASH 2025) - "Thetreatment was well tolerated, with injection site reactions as the principal treatment-related adverseevent. Vididencel is now being assessed as post-remission/maintenance therapy in a randomized phaseIIb study in high-risk AML (AMLM22/D4)."

Clinical • IO biomarker • Residual disease • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • ASXL1 • CD8 • DNMT3A • JAK2 • LAG3 • PHF6 • PPM1D • PRAME • RUNX1 • SRSF2 • TET2 • TP53 • WT1

Mendus Announces Summary of Data Presented at ASH (Mendus Press Release) - "Updated results from the European ADVANCE II Phase 2 trial continue to demonstrate robust relapse-free and overall survival benefit in a high-risk AML population, based on the presence of persistent measurable residual disease (MRD) following IC. At a median follow-up of 55 months, 13 out of 20 patients treated with vididencel were still alive, with 8 patients having passed 5-year follow-up and estimated 5-year overall survival standing at 63%. Immunological data tracked with survival and no associations with tumor genetics were observed, confirming that vididencel acts as an active immunotherapy against residual disease across different subtypes of AML."

P2 data • Acute Myelogenous Leukemia

Mendus is therefore preparing the DIVA Phase 1b combination trial, which will study safety and feasibility of vididencel in combination with ven+aza to address this growing patient population. The DIVA trial will also be led by Prof. Wei and is anticipated to start in the first half of 2026. (Mendus Press Release)

New P1 trial • Acute Myelogenous Leukemia

Trial in progress: A Phase IIb randomized clinical trial combining oral azacitidine and vididencel, a novel immunotherapy, for post-remission / maintenance therapy for adult patients with cytogenetically intermediate and high-risk Acute Myeloid Leukemia (ALLG AMLM22/D4 CADENCE) (ASH 2025) - "We gratefully acknowledge the patients and families. Contact: www.allg.org.au"

Clinical • IO biomarker • P2b data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma

NorthX Biologics achieves milestone GMP certification to manufacture vididencel – Mendus’ lead cell therapy product for acute and chronic myeloid leukemias (Cision) - "For two years, NorthX Biologics and Mendus have collaborated closely to adapt NorthX Biologics’ GMP facilities for allogeneic cell therapy production, perform tech transfer of the vididencel process, and manufacture clinical batches in accordance with stringent regulatory standards. The process development and manufacturing journey has reinforced Sweden’s position as a hub for advanced therapy medicinal products (ATMPs) and enabled Mendus to accelerate its oncology pipeline."

Commercial • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia

Vididencel, a Leukemia-Derived Dendritic Cell Vaccine, Acts Synergistically with Azacitidine/Venetoclax Treatment in a Preclinical AML Model (ASH 2024) - "In conclusion, results from these in vitro and in vivo experiments show that vididencel can be combined with AZA and/or VEN and that combination treatment leads to synergism, with superior tumor growth reduction. This provides support for the use of vididencel in combination with both azacitidine and venetoclax in clinical trials."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD34

Vaccination Using an Allogeneic Leukemia-Derived Dendritic Cell Vaccine, Maintains and Improves Frequencies of Circulating Antigen Presenting Dendritic Cells Correlating with Relapse Free and Overall Survival in AML Patients (ASH 2023) - P2 | "Patients who remain in CR after vididencel treatment had highest baseline levels of HLA-DR+ CD45RA+ cells, which could be myeloid cells able to differentiate into dendritic cell subsets, as in general CD45RA+ is lost during maturation from precursor to matured dendritic cells. Vaccination might improve and induce maturation of dendritic cell subsets, such as cDC1, cDC2 and pDC, which enhance antigen capturing, processing and presentation to tumor-reactive T cells, ultimately leading to improved survival."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD123 • CD14 • CD1C • CD8 • CDK1 • IL3RA • ITGAM • PTPRC

Intradermal Vaccination with Vididencel in MRD+ AML-Patients Leads to Increase in Antigen Presenting Cells and T-Cells to the Injection Site, Visualized Using Imaging Mass Cytometry, Showing Local Immune Cell Interactions Leading to Systemic Immune Responses (ASH 2023) - P2 | "The observed co-localization of the different immune subsets following vaccination supports the hypothesis of local antigen capturing by blood derived and local antigen presenting cells (Zuo et al, 2021). The local immune response may ultimately leads to a systemic immune response and disease control."

Clinical • Immune cell • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD1C • CD68 • CD8 • GZMB

In Vitro interactions between TKIs and Leukemic-Derived Dendritic Cells As Potential Combination Therapy for Chronic Myeloid Leukemia (ASH 2024) - "The development of tyrosine kinase inhibitors (TKIs) such as imatinib, nilotinib, dasatinib, and bosutinib has resulted in substantial improvement of clinical outcomes in the treatment of chronic myeloid leukemia (CML). Second generation TKIs, such as nilotinib, bosutinib and dasatinib impaired T-cell proliferation in MLR assay, with dasatinib having the strongest effect. Further preclinical experiments and ultimately clinical studies should provide more insights in the interaction between TKIs and vididencel in vivo and to explore its potential as an immunotherapy to improve TFR success in CML."

Combination therapy • IO biomarker • Preclinical • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • CD4 • CD8 • CD80 • CD83 • PRAME • WT1

Active Immunotherapy with Vididencel As Maintenance Treatment in MRD+ AML Patients in CR1 Results in Strong Anti-Tumor Immune Responses and Durable Long-Term Survival in Patients with an Immune Competent Immune Profile (ASH 2024) - P2 | "Optimum results were obtained in patients in which sustained T-cell responses towards tumor-associated antigens were induced and in those with an immune competent immune profile (high in B-cells and low in immune suppressive CD8+LAG3+ CM T-cells), supporting the presumed mechanism of action of vididencel as active immunotherapy. Currently, vididencel is being assessed in combination with oral azacitidine as AML maintenance therapy after intensive induction therapy, aiming to further improve RFS and OS."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CD8 • LAG3 • PRAME • WT1