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Transitioning Towards Late-Stage Development

In 2023, Mendus put in place the building blocks that allow us to transition into a late-stage clinical development company. The positive Phase 2 data with our lead product vididencel in acute myeloid leukemia (AML) presented at the ASH conference in December capped a year with strong progress.

Erik Manting, Chief Executive Officer.
 

On the regulatory front, we further strengthened the vididencel dossier with an ATMP certificate from EMA and a Fast Track Designation granted by the FDA. We also secured additional financing, established a manufacturing alliance with NorthX Biologics and entered into a partnership with the Australasian Leukaemia and Lymphoma Group (ALLG) to expand the clinical development of vididencel.

Mendus presented three clinical abstracts at the 65th American Society of Hematology Annual Meeting (ASH) held in December, including an oral presentation of the ADVANCE II Phase 2 trial survival data. The presented
data showed 14 of 20 patients to be alive in long-term follow-up, with 11 still in first complete remission. With a median follow-up of 31.6 months, median relapse-free survival stood at 30.4 months (2.5 years). Immunomonitoring data confirmed the mode of action of vididencel as an immunotherapy that boosts active immunity against residual disease. Relapse is the main hurdle to long-term survival in AML and maintenance therapy, aimed at prolonging disease-free survival, is therefore the new frontier in the treatment of AML. Maintenance therapy should however not come at the expense of health and quality of  life. The potential to deliver long-term survival benefit, in combination with a strong safety profile, therefore makes vididencel one of the most promising AML maintenance therapies currently in development.

The clinical development of vididencel is supported by a strong regulatory dossier, with Orphan Drug Designations granted in Europe and the US. In June 2023, Mendus secured an ATMP certificate by the EMA, validating our investments into the vididencel preclinical dossier and manufacturing process and also in 2023, the US FDA granted Fast Track Designation for vididencel in AML. Advantages of the Fast Track Designation include close interactions with the FDA to support accelerated approval, as well as the possibility of a ”rolling review” for a subsequent market application.

In December, Mendus announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to expand the clinical development of vididencel in combination with oral azacitidine, currently the only approved AML maintenance treatment. Preclinical research and data from the completed Phase 1 trial with vididencel in high-risk AML and myelodysplastic syndrome (MDS) patients published in November indicate that vididencel can be safely and effectively combined with azacitidine. Together with ALLG, Mendus will now study the combination of vididencel and oral azacitidine in the randomized controlled AMLM22-CADENCE trial. The first stage of the study will assess the safety of the combination in 40 patients and in the second stage, the efficacy of the combination will be assessed in an additional 100 patients. Mendus had already established an extensive network of European clinical centers and an open investigational new drug (IND) application to support clinical development of vididencel in the US. The collaboration with ALLG will significantly strengthen Mendus’ clinical trial network in Australia, New Zealand and selected Asian countries.

The data presented at different conferences in 2023 from the ALISON Phase 1 trial with vididencel in ovarian cancer confirmed safety and revealed the triggering of T cell responses against multiple tumor antigens previously identified as relevant for this indication. Additional read-outs of the ALISON trial are expected in 2024, including a primary read-out in 2024H2. Mendus’ second clinical-stage product, the intratumoral immune primer ilixadencel, has been prepared for clinical development in soft tissue sarcomas. Mendus is currently in advanced discussions with potential collaborators to enter into a Phase 2 trial with ilixadencel and expects to announce details of the trial in the first half of 2024.

In July, Mendus completed a financing round comprising a directed placement and rights issue totaling SEK 317M. In conjunction with the financing, Mendus announced that it had entered into a manufacturing alliance with NorthX Biologics. The alliance will support large-scale manufacturing and marks a crucial step on the path towards pivotal-stage development and commercial launch of vididencel. In the second half of 2023 and first quarter of 2024, Mendus and NorthX Biologics have completed the installment of the vididencel manufacturing facility in the NorthX Biologics’ Matfors site in Sweden and initiated the first steps in the transfer of the manufacturing process to the new facility.

In 2024, Mendus will focus on preparing for late-stage development of vididencel in AML, by developing a registration trial protocol in close alignment with the regulatory authorities EMA and FDA. The vididencel manufacturing process will be transferred from Mendus to the new facilities now installed at NorthX Biologics, to be ready for large-scale manufacturing in the first half of 2025. The initial data collected in the AMLM22-CADENCE trial are expected to confirm vididencel’s excellent safety profile in combination with oral azacitidine in the AML maintenance setting. We look forward to keeping our stakeholders updated on the progress of vididencel in AML and our additional pipeline programs.

We continue our mission to change the course of cancer treatment, by developing immunotherapies that have the potential to improve disease-free and overall survival in hard-to-treat tumors, without compromising health or quality of life. We are particularly grateful for the dedication of the clinical centers and the patients who participate in our clinical trials. Finally, we thank our shareholders, our collaborators and all other stakeholders for their continued support.

Erik Manting
CEO

 

*Published on April 17, 2024