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Letter from the CEO
So far in 2023, Mendus has realized significant progress in its corporate development and we aim to end the year strong.
The progress made in the previous quarters provided the basis for a financing round which we completed in July, to support the next stage of our corporate development. The directed placement and rights issue totaling SEK 317M supports further read-outs of the ongoing ADVANCE II and ALISON vididencel trials, the start of new clinical trials with vididencel and ilixadencel and progressing our preclinical pipeline. Additionally, Mendus has entered into a manufacturing alliance with NorthX Biologics, to support large-scale manufacturing of its lead product candidate vididencel. The regulatory status of vididencel was strengthened in Q3 by the Fast Track Designation granted by the US FDA.
Erik Manting, Chief Executive Officer.
The main milestone ahead of us in the fourth quarter of 2023 is the next read-out of the patient survival data in the ADVANCE II trial, which studies vididencel as a maintenance therapy for acute myeloid leukemia (AML). The data will be presented as an oral presentation at the 65th American Society of Hematology conference (ASH 2023), the largest and most significant hematology conference in the world, to be held December 9-12 in San Diego. It will be the third time Mendus presents the ADVANCE II trial data as an oral presentation at ASH, which underscores the high interest in vididencel as a potential novel AML maintenance treatment by the medical specialist community.
The ADVANCE II trial is a Phase 2 monotherapy trial addressing AML patients in complete remission, but with measurable residual disease (MRD), which is associated with fast relapse and, as a result, strongly reduced overall survival. The ADVANCE II data presented last year at ASH 2022, revealed that the majority of patients were not only alive at the end of the 70-week study period, but also remained alive and disease-free in long-term follow up ranging from 16 to 47 months. The monotherapy survival data, combined with an excellent safety profile, strongly support the development of vididencel as a novel maintenance treatment in AML. The next data read-out to be presented at ASH 2023 will provide an update on both relapse-free and overall survival.
The ADVANCE II trial is reinforced by immunomonitoring studies, which document the effect of vididencel on the immune system. Immunomonitoring data demonstrating the boosting of broad and robust immune responses were presented at leading scientific conferences, including the International Cancer Immunotherapy Conference (CICON) in September. At ASH 2023, next to the oral presentation of the survival data, we and our scientific partners at different academic hospitals will present two additional abstracts, which describe in detail the immune responses observed in the skin and in the blood following intradermal injection of vididencel, supporting its mode of action.
As a next step in the development of vididencel, Mendus is preparing for a combination trial of vididencel with oral azacitidine (oral AZA), currently the only approved AML maintenance drug). Together with the ADVANCE II monotherapy data, the Phase 2 combination trial with oral AZA will be a step up towards pivotal-stage development of vididencel in the AML maintenance setting. Mendus expects to announce details and start of the trial before year-end 2023.
In Q3, Mendus has taken the first steps in implementing the manufacturing alliance with NorthX Biologics, a leading Nordic contract development and manufacturing organization for cell and gene therapies. Large-scale, commercial-grade manufacturing is an important step for late-stage clinical development of vididencel and NorthX will therefore be a significant partner for Mendus going forward.
In September, the US FDA granted Fast Track Designation for the development of vididencel as an AML maintenance therapy, adding substantial regulatory value to the program in the most important healthcare market worldwide. The development of vididencel towards market registration in AML is also supported by Orphan Drug status in the EU and US and the vididencel manufacturing process and regulatory dossier has been validated by an EMA Advanced Therapy Medicinal Products (ATMP) certificate.
Data from the Phase 1 ALISON trial studying vididencel as a maintenance therapy in ovarian cancer were presented at the American Association for Cancer Research (AACR) conference held in April 2023 and the Society for Immunotherapy of Cancer (SITC) conference early November. The data confirmed the benign safety profile and potential of vididencel to stimulate immune responses against tumor antigens previously shown to be relevant for ovarian cancer. Recruitment of the ALISON trial (n = 17) is nearly complete with 16 patients having entered the trial and is expected to close before year-end 2023. Next read-outs of the ALISON trial are expected in the first half of 2024.
Following a series of manufacturing process improvements, Mendus’ second clinical-stage program ilixadencel is ready to be tested in a proof-of- concept trial based on initial positive data observed in gastrointestinal stromal tumors (GIST). There is continued clinical interest in pursuing a trial with ilixadencel in soft-tissue sarcomas, of which GIST is a subtype. The trial is expected to commence before year-end 2023. In Q3, Mendus announced the publication of preclinical data supporting the combination of ilixadencel with 4-1BB checkpoint modulators in a peer-reviewed journal.
In 2023, Mendus has so far realized significant progress in its corporate development, and we aim to end the year strong, based on the next ADVANCE II update at ASH, the start of a vididencel combination trial with oral AZA, the shaping of our alliance with NorthX Biologics and additional clinical milestones. We look forward to keeping our shareholders informed of our progress and thank you for your continued support.
CEO of Mendus
*Published on November 9, 2023
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