Mendus AB

Mendus AB (publ) Interim Report January – March 2023 - Seite 2

While a next survival update of the ADVANCE II trial is expected in the second half of 2023, Mendus continues with the in-depth analysis of the immunomonitoring samples collected as part of the trial. These data help us to enhance the understanding of the immune system of patients before and after vididencel treatment, further supporting the positioning of vididencel as a novel immunotherapy modality in AML maintenance. The data will be prepared for presentation at medical-scientific conferences, starting with the 2023 Cancer Immunotherapy (CIMT) meeting. As a next step in the development of vididencel, Mendus will prepare for a trial in combination with current standard of care as a step-up to pivotal-stage development, with oral azacitidine as the most logical combination partner. In preclinical studies, vididencel was shown to act synergistically with current and two upcoming small molecule AML drugs azacitidine and venetoclax.

Mendus has selected ovarian cancer to explore vididencel in a solid tumor setting. Ovarian cancer is the deadliest gynaecological cancer due to high recurrence rates after initial treatment, providing for the rationale to explore the safety and feasibility of vididencel as maintenance treatment option in this disease. Most recently, data from the ALISON trial were presented at the American Association for Cancer Research (AACR) conference held in April 2023. The initial data are encouraging, confirming safety and the potential of vididencel to stimulate immune responses against tumor antigens previously shown to be relevant for ovarian cancer. Based on the positive data collected so far, recruitment of the ALISON trial will continue, and additional read-outs are expected in the second half of 2023.

Mendus’ second clinical-stage program is the intratumoral immune primer, ilixadencel. Mendus is preparing for a next clinical trial with ilixadencel in gastro-intestinal stromal tumors (GIST) as a prioritized indication, based on signs of clinical efficacy in this indication in earlier clinical trials. There continues to be clinical interest to pursue a trial in GIST and potentially the broader group of soft-tissue sarcomas. In parallel, Mendus has successfully implemented a series of technical and equipment-related optimizations of the ilixadencel manufacturing in order to support future product supply and for the continued clinical development of ilixadencel.