Press Release

Stockholm, Sweden, May 16, 2024
 

UPDATED CLINICAL DATA FROM THE ADVANCE II TRIAL DEMONSTRATE THE POTENTIAL OF VIDIDENCEL TO INDUCE EFFECTIVE T CELL RESPONSES AND IMPROVE OVERALL IMMUNE STATUS IN ACUTE MYELOID LEUKEMIA

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, today announces that it will present updated clinical data from the ADVANCE II clinical trial in acute myeloid leukemia (AML) at the Cancer Immunotherapy (CIMT) Annual Meeting, being held from May 15-17, 2024 in Mainz, Germany. The data demonstrate the potential of vididencel to induce broad immune responses in AML patients, which are associated with improved survival.

The updated clinical data to be presented are based on immunological analyses of patient samples collected as part of the ongoing ADVANCE II clinical trial in AML. The immunomonitoring data demonstrate the potential of vididencel to induce tumor antigen-specific T cell responses and improve the immune competency in patients suffering from AML. As a whole cell-based vaccine, vididencel carries a broad range of known and unknown cancer antigens. Following vididencel treatment, T cell responses against one or more tumor antigens that are regularly upregulated in AML, including WT-1, RHAMM and PRAME, were detected in the vast majority of patients (85%).

Immune profiling of peripheral blood mononuclear cells (PBMC) was done before and during vididencel treatment to evaluate changes in immune cell composition. Clear differences were observed at baseline between patients who experienced durable clinical remissions and patients who relapsed. An immune compromised profile characterized by high levels of CD8+ central memory (CM) T cells and CD8+ LAG3+ suppressor T cells, combined with low levels of B-cells and dendritic cells (cDC1 and cDC2) was observed in relapsed patients, as compared to patients who experienced clinical benefit. During vididencel treatment, changes in immune cell composition were observed towards a more immune competent profile, shown by increases in dendritic cells, B-cells and decreases in CD8+ LAG3+ cells. Heatmap analysis per patient showed clear shifts in immune cell compositions over time.

The data support vididencel’s mechanism of action as a therapy that improves immune control over residual disease, resulting in prolonged disease-free survival. The results also provide for a deeper understanding on the role of the individual immune cell subsets in the mounting of an effective anti-tumor immune response. Vididencel treatment resulted in an overall improvement of the immune status towards an immune competent profile and high numbers of T-cell responses, associated with longer relapse-free and overall survival.

Please see below for abstract details:

Abstract Number:  151 (poster presentation)

Abstract Title: Vaccination with a leukemic-cell derived cancer vaccine (vididencel) improves anti-tumor immune competency in AML patients correlating with improved survival

Authors: Hester van Zeeburg, Eva Wagner-Drouet, Uwe Platzbecker, Tobias Holderried, Catharina van Elssen, Aristoteles Giagounidis, Bjorn Gjertsen, Arjan van de Loosdrecht, Jeroen Rovers

Session Date & Time: Thursday, 16 May 2024 between 5:00 pm - 7:30 pm

Mendus also announces the presentation of updated data from its preclinical NK cell program during the CIMT conference. Mendus applies its proprietary DCOne platform to expand memory NK cells from donor material. Memory NK cells are associated with improved survival in cancer, particularly in blood-borne tumors following hematopoietic stem cell transplantation (HSCT, or “bone marrow transplant”). The data presented at CIMT describe the development of a robust expansion protocol for donor-derived memory NK cells using DCOne mDC. The expanded memory NK cells exhibit strong tumor cell killing capacity, particularly in combination with tumor-specific antibodies. The NK cells expanded in the presence of DCOne mDC also demonstrated superior persistence as compared to NK cells expanded with other expansion methods. The data support the use of memory NK cells expanded using the DCOne platform for adoptive immunotherapy, including combinations with tumor-targeting antibodies or NK cell engagers, in different hematological malignancies.

Please see below for abstract details:

Abstract Number: 57 (poster presentation)

Abstract Title: DCOne-derived dendritic cells promote robust in vitro expansion of memory NK cells with strong tumor cell cytotoxicity and high persistence

Authors: Haoxiao Zuo, Ziyu Wang, Jyoti Naik, Jorn Kaspers, Alex Karlsson-Parra and Satwinder Kaur Singh

Session Date & Time: Wednesday, 15 May 2024 between 3:00 pm - 5:30 pm

The abstracts are available on the CIMT 2024 conference website. After the conference, the posters will be available on the Mendus website.