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Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence in life-threatening cancers, today announces a summary of the data presented at the 30th European Hematology Association Congress (EHA), held from June 12 to June 15, 2025, in Milan Italy. The clinical data presented based on the European ADVANCE II Phase 2 clinical trial confirms that vididencel acts as a mutation-agnostic immunotherapy in acute myeloid leukemia (AML), supporting a broad positioning as post-clinical remission therapy, independent of specific mutations in this indication.
“The potential of vididencel in AML lies in the fact that it is an active immunotherapy leading to durable clinical remissions in AML combined with a robust safety profile,” said Mendus CMO Tariq Mughal. “The data collected in our clinical trials show that vididencel is most effective in a low-disease setting, where it has the potential to stimulate immune control over residual disease. The data presented at EHA consolidates the positive data seen in studies and supports further studies in all subtypes of AML for patients in complete remission.”
AML is a highly heterogenous disease driven by multiple cancer-related mutations that differ from patient to patient and may evolve over time. This makes it a hard-to-treat disease with targeted therapies, which are dependent on individual mutations. The only potentially curative approach to AML is immunotherapy based on allogeneic hematopoietic stem cell transplantation (HSCT), but this treatment is associated with significant transplant-related morbidity and mortality.
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. At EHA, Mendus presented data comparing clinical responses of patients with tumors carrying common NPM-1 mutations with patients without such mutations and showed that there was no difference in clinical outcome between both patient groups. The data confirm that vididencel acts as a mutation-agnostic immunotherapy.
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. The presence of CMV-trained memory NK cells has been shown to be associated with improved clinical outcomes in blood-borne tumors following HSCT. Reliable methods to expand therapeutic quantities of memory NK cells may therefore lead to novel NK cell therapies for blood-borne tumors, particularly in the post-HSCT setting. The data presented at EHA showed that memory NK cells expanded with Mendus’ DCOne technology demonstrated good tumor cell killing capacity and persistence in vitro, independent of donor CMV-status.
Please see below for details of the abstracts presented at EHA:
Abstract Number: PS1507 (poster presentation)
Abstract Title: LONG TERM SURVIVAL AND VACCINE-INDUCED IMMUNE RESPONSES ARE COMPARABLE BETWEEN NPM1 MUTATED VS NPM1 WILD TYPE AML PATIENTS AFTER IMMUNOTHERAPY WITH VIDIDENCEL
Authors: Arjan van de Loosdrecht, Hester van Zeeburg, Jeroen Rovers, Jacqueline Cloos, Eva Wagner-Drouet, Uwe Platzbecker, Tobias Holderried, Janine van Elssen, Aristoteles Giagounidis, Bjørn T. Gjertsen
Session Date & Time: Saturday, June 14 between 18:30 - 19:30 CEST
Abstract Number: PF1140 (poster presentation)
Abstract Title: EXPANSION OF FUNCTIONAL MEMORY NK CELLS FROM CMV-POSITIVE AND -NEGATIVE DONORS USING LEUKEMIC-DERIVED DENDRITIC CELLS
Authors: Haoxiao Zuo, Ziyu Wang, Jyoti Naik, Alex Karlsson-Parra and Satwinder Kaur Singh
Session Date & Time: Friday, June 13 between 18:30 - 19:30 CEST