Stockholm, Sweden, November 6, 2023
Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced the publication of updated clinical data from the ongoing ALISON Phase 1 trial with the company’s lead program vididencel at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting, the largest conference for cancer immunotherapy. The data demonstrate the boosting of broad immune responses in the majority of patients and a continued strong safety profile of vididencel.
Treatment of advanced ovarian cancer after surgery and chemotherapy remains challenging, due to high recurrence rates. The ALISON trial evaluates the use of vididencel as a maintenance treatment in ovarian cancer, aimed to prevent disease recurrence after first line treatment.
“While we are nearing completion of enrollment, the ALISON trial data presented at SITC 2023 demonstrate the potential of vididencel to boost a broad immune response, which is a prerequisite for controlling residual cancer cells and avoiding immune escape by tumor cells,” commented Jeroen Rovers, MD, PhD, Chief Medical Officer at Mendus. “We expect to fully enroll the ALISON trial before the end of 2023 and to report further clinical updates, including survival updates, in the first half of 2024.”
The data presented at SITC demonstrate that vididencel induces immune responses against tumor-associated antigens which are frequently upregulated in ovarian cancer. At the cut-off date for the SITC conference, 16 out of 17 patients had been enrolled in the ALISON study. T cell responses against a broad range of tumor-associated antigens present in vididencel were seen in 6 out of 8 evaluable patients. Immune responses against tumor-associated antigens, which are not present in vididencel were also observed following vididencel administration, suggesting broadening of the immune response due to so-called antigen spreading caused by tumor cell lysis. In addition to the observed T cell responses, B cell responses were improved, as demonstrated by the increased presence of memory B-cells and precursors of antibody-secreting B-cells in the majority of patients treated with vididencel.
The full abstract entitled “Induction of specific T-cell responses against tumor associated antigens and induction of B-cell responses in ovarian cancer patients by intradermal injection of vididencel” is available on the SITC conference website. The scientific poster presented at SITC 2023 is available via the Company’s website.
More information on the ALISON study is available on clinicaltrials.gov (trial ID: NCT04739527)
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Erik Manting, CEO
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/
Vididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel.