vididencel (DCP-001) / Mendus - LARVOL DELTA

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

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

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

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

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

Analysis of NCI Community Oncology Research Program (NCORP) clinical trial accrual rates in a comprehensive cancer center and its community affiliate sites. (ASCOQLTY 2025) - " A total of 368 patients in a comprehensive cancer center and its community affiliate sites were screened using NCI's standardized DCP-001 tool to assess eligibility for NCORP clinical trials... Associations between each variable and trial participation prompts insight into factors that can be optimized to increase accrual rates among patients less likely to enroll based on certain characteristics. Ultimately, if higher trial accrual rates can be obtained amongst those less likely to enroll, we can more rapidly advance treatments that are applicable to the entire population."

Clinical • Oncology • Thoracic Cancer

Intradermal Vididencel Vaccination in Measurable Residual Disease-Positive Acute Myeloid Leukemia Patients Results in Increased Antigen-Presenting Cells and T Cells at the Injection Site and Local Immune-Cell Interactions (SOHO 2025) - P2 | "Vididencel vaccination triggered a transient inflammatory skin reaction in most patients, indicative of a local immune response. Immunohistochemistry showed an influx of T cells and antigen-presenting cells, including dendritic cells. Multiparameter imaging mass cytometry further detailed the specific immune cell subsets infiltrating the injection sites."

Clinical • Immune cell • Residual disease • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD1C • CD68 • CD8 • GZMB

Mendus granted US patent for use of vididencel in ovarian cancer (Mendus Press Release) - "Mendus AB...announces that the United States Patent and Trademark Office (USPTO) has granted a patent in the US covering the use of Mendus’ lead product vididencel in ovarian cancer....The newly approved patent (US 12,364,758) covers the use of vididencel in ovarian cancer and expires in November 2042. Corresponding patent applications are pending in other regions including Europe....Vididencel is currently being studied in the ongoing Phase 1 trial ALISON as a maintenance therapy for ovarian cancer in combination with standard of care....A next read-out of the trial based on 2-year follow-up is anticipated in the fourth quarter of 2025."

P1 data • Patent • Ovarian Cancer

AMLM22/D4: The International AML Platform Consortium (IAPC) trial – Combining Oral Azacitidine and Dendritic Cell Vaccination Vididencel in maintenance (CADENCE) (ANZCTR) - P2 | N=140 | Recruiting | Sponsor: Australian Leukaemia and Lymphoma Group (ALLG) | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1

Data presented at EHA strengthens Mendus’ programs in myeloid leukemias (Mendus Press Release) - "Mendus has reported positive Phase 2 data with its lead product vididencel, an active immunotherapy that induces tumor-directed immune responses associated with long-term disease-free and overall survival benefit in AML....Mendus also presented preclinical data from its NK cell program, demonstrating that memory NK cells can be efficiently expanded from donor blood using Mendus’ propriety DCOne platform, independent of donors having previous cytomegalovirus (CMV) infections."

P2 data • Preclinical • Acute Myelogenous Leukemia

LONG TERM SURVIVAL AND VACCINE-INDUCED IMMUNE RESPONSES ARE COMPARABLE BETWEEN NPM1 MUTATED VS NPM1 WILD TYPE AML PATIENTS AFTER IMMUNOTHERAPY WITH VIDIDENCEL (EHA 2025) - P2 | "In conclusion, active immunotherapy with vididencel induces tumor-specific immune responses in AML patients in CR1 after chemotherapy induction/consolidation, and is associated with a reduction in MRD and improved overall survival compared to historical controls. Patients with an NPM1 mutation show comparable T-cell responses, RFS and OS as compared to NPM1-wt patients. In this study, patient outcome after vididencel treatment was independent of the NPM1 mutational status."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1 • PRAME • WT1

ALISON trial data presented at ASCO 2025 demonstrates successful induction of tumor-directed immune responses in high-risk ovarian cancer (Mendus Press Release) - P1 | N=17 | ALISON (NCT04739527) | "The Phase 1 ALISON trial evaluates safety, efficacy and immunogenicity of vididencel in patients with high-grade mutation agnostic serous ovarian cancer (HGSOC)....At week 22 from start of vididencel treatment, 10 patients participating in the ALISON trial had stable disease and 7 had progressive disease, with all patients still alive. Stable disease rates were highest (67%) in patients with vididencel-induced immune responses (VIR) as compared to patients without VIR (40%). Updated survival data until March 2025 showed that 7 patients continued to have stable disease and 10 patients had developed progressive disease at a median follow-up of 19 months, with 10 patients still alive. Stable disease was associated with vididencel-induced immune responses, with VIR observed in 6 out of 7 of the patients with stable disease....A next read-out of the trial based on 2-year follow-up is anticipated in the fourth quarter of 2025."

P1 data • Ovarian Cancer

Successful induction of tumor-directed immune responses in high grade serious ovarian carcinoma patients after primary treatment using a whole tumor cell vaccine. (ASCO 2025) - P1 | "Vididencel is well tolerated and effective in eliciting or boosting a broad T-cell response in HGSOC patients after primary treatment. Short-term evaluation of clinical response at week 22 suggests better responses in patients developing a VIR or sVIR compared to those patients not having a detectable immune response to the vaccine. (s)VIR; (sustained) vaccine induced response."

Clinical • Tumor cell • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MUC16 • PRAME • WT1

Mendus presents AML...program data at CIMT (Mendus Press Release) - P2 | N=20 | ADVANCE-II (NCT03697707) | Sponsor: Mendus | "The first abstract...was presented during the poster session on May 12. Mendus had reported that at the latest data cut of the ADVANCE II Phase 2 trial, the majority of patients treated with Mendus’ lead product vididencel were alive at a median follow-up of 41.8 months. Long-term survival was associated with broad immune responses....Individual T cell receptors against WT-1 and other tumor antigens were detected and dynamics were followed over time during vididencel treatment. The study confirms the stimulation of broad tumor-specific immune responses following vididencel treatment, which contribute to the long-term immune control over residual disease in AML."

P2 data • Acute Myelogenous Leukemia

Induction of multiple tumor specific T-cells in long-term surviving AML patients after treatment with a whole tumor cell vaccine (CIMT 2025) - P2 | "In conclusion, vididencel induces T-cell responses to known antigens like WT1, PRAME and RHAMM, but also to other tumor antigens known to be upregulated, overexpressed or associated with AML or other tumors. Vididencel can provide a very broad repertoire of antigens, which might induce a very broad immune T-cell response."

Clinical • Tumor cell • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CTAG1B • PRAME • WT1

First patient enrolled in the AMLM22-CADENCE trial with Mendus’ product vididencel (Mendus Press Release) - "Mendus AB...announced that the first patient has been enrolled in the AMLM22-CADENCE trial, which studies Mendus’ lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML)....The first stage of the AMLM22-CADENCE trial will randomize 40 patients and in the second stage, efficacy of the combination will be assessed in an additional 100 patients."

Enrollment status • Acute Myelogenous Leukemia

FDA and EMA feedback endorses vididencel registration trial preparations (Mendus Press Release) - "Mendus AB...announces a summary of the feedback received from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the fourth quarter of 2024. The feedback is supportive of the preparations for a registration trial with Mendus’ lead program vididencel in acute myeloid leukemia (AML)....Both FDA and EMA supported the trial design, patient population, reference therapy, primary and secondary endpoints and statistical analysis strategy, as proposed by Mendus. The Phase 3 study design was considered appropriate to demonstrate efficacy in the intended patient population. Both agencies also agreed to the development steps taken by Mendus towards establishing large-scale manufacturing of vididencel, including the required comparability protocol."

Clinical protocol • European regulatory • FDA event • Acute Myelogenous Leukemia

Mendus announces termination by Institut Bergonié of the collaboration agreement to study ilixadencel in soft tissue sarcomas (Mendus Press Release) - "Mendus AB...announces that Institut Bergonié has terminated the collaboration agreement with Mendus, because it is no longer in a position to study Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial. Mendus has decided to not pursue new clinical trials and to explore alternative strategic options for the ilixadencel program....Due to evolving business needs, Bayer AG will no longer support the REGOMUNE trial and Institut Bergonié is therefore no longer in a position to open new study cohorts for the trial. As a consequence of the termination of the collaboration agreement with Institut Bergonié and in the light of the positive data with its lead program vididencel, Mendus has decided to not pursue new clinical trials with ilixadencel and to focus its clinical development strategy on vididencel."

Commercial • Soft Tissue Sarcoma

Updated data from the ADVANCE II Phase 2 trial presented at ASH demonstrate durable survival of AML patients treated with vididencel (Mendus Press Release) - P2 | N=20 | ADVANCE II (NCT03697707) | Sponsor: Mendus | "The updated ADVANCE II data presented at ASH show that 13 out of 20 patients treated with vididencel were alive and 11 patients were still in CR1 as of the November 4, 2024 cut-off-date, with a median follow-up of 41.8 months. Median relapse-free (RFS) and overall survival (OS) was not reached, as the majority of patients remained alive and disease-free. All patients had passed 3-year follow-up and 2 patients completed 5-year follow-up. The 1-year survival stood at 88%, 3-year survival at 71% and the estimated 5-year survival was 58%. The only drug approved for post-chemo AML maintenance therapy is oral azacitidine, which in MRD-positive patients led to a median RFS of 7.1 months and a median OS of 14.6 months in the registration trial1. The estimated 3-year OS for the whole treated patient population which included MRD-positive and -negative patients was 37.4% and 5-year OS was 26.5%2."

P2 data • Acute Myelogenous Leukemia