Mendus AB

Mendus AB (publ) Interim Report January – March 2023

In the first quarter of 2023, Mendus continued on the path set out by the key progress realized at the end of 2022. The Phase 2 monotherapy proof-of-concept data from the ADVANCE II trial presented last December at the American Society for Hematology conference support the continued clinical development of vididencel (DCP-001) in combination with standard of care, for which we are preparing the next steps. In the meantime, we continue with the in-depth analysis of the immunomonitoring data collected as part of the ADVANCE II trial. The data teach us a lot about the way vididencel stimulates the immune system and which immunological parameters are important to improve immune control or even achieve complete elimination of residual disease. The successful initial read-outs on safety and feasibility of the ALISON Phase 1 trial studying vididencel in ovarian cancer allow us to continue the enrollment of patients and provide additional trial updates in the remainder of 2023. Our intratumoral primer ilixadencel will benefit from manufacturing process improvements for which we have laid the foundation in 2022, as a prerequisite for continued clinical development. Finally, we have discovered a method to expand memory NK cells using our DCOne platform, allowing us to enter the exciting field of NK cell-based therapies and providing us with a basis for a potential new pipeline program to be further established in 2023 and beyond.

Acute myeloid leukemia (AML) is an aggressive blood-borne tumor leading to rapid disturbance of the bone marrow and blood count. Even when AML is treated successfully with high-dose chemotherapy and results in complete remission according to clinical parameters, relapse rates are very high due to the presence of residual tumor cells. Therefore, there is a big medical need for maintenance therapies, designed to prevent or delay relapse, particularly for patients with measurable residual disease (MRD). In the registration trial for the current standard of care in AML maintenance, oral azacitidine, the median relapse-free survival in MRD-positive patients following high-dose chemotherapy was 7.1 months versus 2.7 months for placebo¹. These data underline the continued unmet medical need for AML maintenance treatments resulting in more durable clinical responses. In December 2022, Mendus presented survival data from the ADVANCE II trial at the American Society of Hematology (ASH) conference, studying its lead compound DCP-001 as a monotherapy maintenance treatment in AML patients who had undergone high-dose chemotherapy but were still MRD-positive. The majority of patients (14/20) were still alive at the end of the 70-weeks study period and 12 patients remained disease-free during the long-term follow-up ranging from 16 to 47 months. Immunomonitoring data confirmed that DCP-001 treatment resulted in increased immune responses to tumor antigens, whereby highest average levels were observed in patients having a complete MRD response. The safety profile of DCP-001 continues to be excellent, with product-related side effects limited to injection site reactions. Shortly following the successful read out of the ADVANCE II trial, in January 2023, the progress of DCP-001 was reflected in the selection of the INN name “vididencel” by the World Health Organization’s International Nonproprietary Names Expert Committee and we will increasingly use it in all our materials.