Press Release
 
Stockholm, Sweden, December 18, 2024

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces positive topline data from the ALISON Phase 1 clinical trial with its lead product vididencel in ovarian cancer. The data collected from all 17 patients treated confirm that vididencel stimulates immune responses against ovarian cancer antigens, as a potential basis for an effective anti-tumor response. The strong safety profile for vididencel was confirmed.

The ALISON trial is a single-center Phase 1 trial carried out by the University Medical Center Groningen, The Netherlands (UMCG). The trial explores the potential of vididencel to induce clinically relevant immune responses in high-grade serous ovarian carcinoma (HGSC). Mendus and UMCG had earlier reported at the ESMO Gynaecological Cancers conference in June 2024 that 10 patients treated with vididencel in the ALISON trial had stable disease and 7 patients had imaging-confirmed recurrence at week 22. Based on the updated analysis of samples collected from all patients treated with vididencel, a vaccine-induced immune response (VIR) against one or more tumor antigens that are regularly upregulated in HGSC was observed in 12 out of 17 patients (71%). The observed immune responses to different tumor antigens provides a potential basis for an effective anti-tumor response. Stable disease at week 22 was observed in 2 out of 5 patients (40%) without VIR, whereas the majority of patients with VIR had stable disease (8 out of 12 patients, or 67%).

“Ovarian cancer is the deadliest gynaecological cancer, particularly due to its high recurrence rate, with recurring tumors being generally unresponsive to earlier lines of treatment.” said Dr Hans Nijman, Professor Obstetrics and Gyneacology and Head of Immuno-oncology at UMCG. “Active immunotherapies like vididencel, which aim to improve immune responses against residual disease, therefore hold promise as a novel treatment option to improve disease-free and overall survival of ovarian cancer patients after primary treatment. We look forward to further evaluate the potential clinical benefit of vididencel based on long-term follow-up of patients treated in the ALISON trial.”

The ALISON trial confirmed the strong safety profile of vididencel, indicating only mild adverse reactions, predominantly at the site of injection. Long-term follow-up of patients treated with vididencel as part of the ALISON trial is ongoing, with a next read-out based on 2-year follow-up expected in 2025Q4.