Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, will present novel clinical and preclinical data on the mode of action of its lead clinical program vididencel at CICON23 – the International Cancer Immunotherapy Conference in Milan, Italy. The data further validate vididencel’s proposed mechanism of action and demonstrate that immune responses triggered by the cell-based cancer vaccine in patients with Acute Myeloid Leukemia (AML) and ovarian cancer are largely comparable. This underlines the potential for a broad applicability of vididencel across different cancer types. The corresponding posters will be presented at CICON23 on Friday, September 22, and afterward made available on the Company’s website.
“The data sets we present at CICON further validate our vididencel program in two significant ways: First, we continue to elucidate the mechanism of action of vididencel, adding data on how antigen-specific T cell responses following vididencel administration are triggered via indirect priming mechanisms. This makes the product suitable as an off-the-shelf product, avoiding the complications associated with cell-based products which depend on the availability of patient material. Secondly, our findings that comparable, robust immune responses against multiple tumor-associated antigens are observed in different tumor types point towards the potential to use vididencel as a backbone therapy for cancer patients in remission more broadly,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus.
The first data set presented at CICON compared the immune responses observed in the currently active clinical trials evaluating vididencel, the ADVANCE II Phase 2 study in AML patients in complete remission with measurable residual disease (MRD) and the ALISON Phase 1 study in ovarian cancer patients at a high risk of relapse after debulking surgery and chemotherapy. Vaccine-induced responses (VIR) were observed in 17 out of 20 AML patients and, at this stage, in 6 out of 7 evaluable ovarian cancer patients. These responses were primarily targeting tumor-associated antigens (TAAs) that are expressed by the vididencel product, such as WT-1 and PRAME. Additionally, in ovarian cancer patients the immune response expanded to include a TAA that is overexpressed in cancer cells but not included in vididencel’s antigen repertoir. In the ADVANCE II study, the number of observed VIRs correlated with clinical responses and survival benefits, which cannot yet be determined for the ALISON study.
The second data set presented at CICON further examined the mechanism of action of vididencel building on previously disclosed data sets. The data were generated in collaboration with the Department of Tumor Immunology, Radboud Institute for Molecular Life Sciences, at the Radboud University Medical Centre, in Nijmegen, the Netherlands. It was previously shown that upon intradermal administration vididencel is absorbed by skin-resident antigen-presenting cells (APCs), which concomitantly become activated to prime the immune system. In a new in vitro study, Mendus and its collaboration partner further investigated how such an indirect priming mechanisms via APCs can result in the activation of antigen-specific T cells.
Vididencel is currently being evaluated in AML and ovarian cancer as a potential maintenance therapy to reduce or prevent tumor recurrence. Vididencel is an off-the-shelf, intradermal vaccine derived from the Company’s proprietary DCOne leukemic cell line. In December 2022, the Company presented positive results from the ADVANCE II study in AML at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to control MRD and induce durable relapse-free survival in the majority of patients. Mendus expects to present a next survival update in the fourth quarter of 2023. Additionally, Mendus anticipates starting a new Phase 2 clinical trial evaluating the combination of vididencel with oral azacitidine, currently the only approved drug in AML maintenance, in H2 2023, as a step-up to pivotal-stage development.
Intradermal vaccination with a leukemic cell based cancer vaccine induces functional CD8 T-cell responses to common tumor antigens in patients with blood-borne and solid tumors
Hester J.T. van Zeeburg, Marco de Bruyn, Hans Nijman, Arjan A. van de Loosdrecht, Jeroen Rovers
The cell-based cancer vaccine vididencel triggers antigen-specific T cell responses via indirect priming mechanisms
Haoxiao Zuo, Jorn Kaspers, Gerty Schreibelt, Jolanda de Vries, Alex Karlsson-Parra and Satwinder Kaur Singh
ABOUT MENDUS AB (PUBL)
Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/
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