Mendus announces clinical pipeline update

Press Release

Stockholm, Sweden, December 22, 2023

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, announced an update on the status and outlook of its clinical pipeline programs.

Mendus reports completion of the long-term follow up of the MERECA trial studying the intratumoral immune primer ilixadencel in metastatic renal cell carcinoma (mRCC). The long-term follow up data confirmed the observations previously reported, with no significant survival difference between the ilixadencel plus sunitinib treatment arm versus the sunitinib-only control arm of the trial. The final results of the MERECA trial confirm the decision not to pursue mRCC as a possible indication for ilixadencel. Mendus continues to explore the clinical development of ilixadencel in soft tissue sarcomas (STS) in the first half of 2024, versus earlier guidance of starting a trial before 2023YE.

“The data from the MERECA trial do not support continued development in renal cell carcinoma. However, ilixadencel remains a promising product candidate for difficult-to-treat solid tumors, such as soft tissue sarcomas”, said Erik Manting, CEO of Mendus.

Mendus also confirms that the Phase 1 ALISON trial with its cancer maintenance therapy vididencel in ovarian cancer is now fully recruited (17 patients). Mendus had earlier reported initial positive interim data from the ALISON trial, based on the induction of immune responses against tumor antigens previously shown to be relevant for ovarian cancer and confirming a strong safety profile for vididencel in this indication. Mendus expects further read outs of the trial in 2024, including a survival analysis in 2024H2.

Mendus recently announced positive data from the Phase 2 ADVANCE II trial with its lead product vididencel in acute myeloid leukemia (AML). The data presented on December 11, 2023 at the American Society of Hematology Annual Meeting (ASH 2023), demonstrated durable clinical remissions in AML patients diagnosed with measurable residual disease (MRD).

“The data with our lead product vididencel recently reported at ASH demonstrated durable clinical benefit in AML, an indication with very high unmet medical need. Mendus therefore remains focused on the regulatory path and increasing the development efforts for vididencel in AML”, Erik Manting added.

As a next step in the development of vididencel in AML, Mendus has announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to study vididencel in combination with the current standard of care in AML maintenance treatment, oral azacitidine, in a 2-stage, control-arm trial including up to 140 patients.