Investors

First steps taken towards late-stage development of vididencel

In March, we were pleased to present a business update together with our partners NorthX Biologics (NorthX) and Australiasian Leukaemia and Lymphoma Group (ALLG), confirming that both partnerships are on track. Also in the first quarter, we received positive FDA feedback on the proposed steps to prepare for late-stage development of vididencel in AML, including the implementation of large-scale manufacturing together with NorthX. Based on the timelines for clinical trial protocol development, including interactions with regulatory agencies, and the manufacturing of the first large-scale GMP batches of vididencel at NorthX, Mendus expects vididencel to be ready for pivotal-stage development in AML in the second half of 2025. The preparations for late-stage clinical development are supported by vididencel’s extensive regulatory dossier.

Erik Manting, CEO
 

Ethics committee approval cleared the path for the start of the Phase 2 AMLM22-CADENCE trial, a trial carried out in collaboration with ALLG. The CADENCE trial will study vididencel as a maintenance treatment for AML in combination with oral azacitidine, currently the only approved AML maintenance drug. Next to the positive data already reported for the ongoing ADVANCE II trial, the data from the CADENCE trial will contribute to the global registration dossier of vididencel in AML.

On March 15, 2024, the exercise period started for the TO3 warrants, which were issued as part of the July 2023 financing round. Mendus’ largest shareholders, as well as the management team and members of the board confirmed their intention to exercise their warrant holdings. In total, around 76 percent of the outstanding warrants were exercised, resulting in approximately SEK 69 million of proceeds, which will extend the cash runway of the company, based on current activities, until the third quarter of 2025.

Mendus’ second clinical-stage product, the intratumoral immune primer ilixadencel, has been prepared for a new Phase 2 trial in soft tissue sarcomas and Mendus is currently in advanced discussions with potential collaborators to perform such a trial. Progress made with Mendus’ preclinical NK cell program, based on tumor cell killing experiments and manufacturing process development, was presented at the annual Innate Killer Summit.

Based on increasing clinical success, cancer vaccines are attracting new interest as a therapeutic modality, particularly for low-disease settings. Mendus is part of that next wave of innovation in cancer immunotherapy and we remain committed to changing the course of cancer treatment, by developing novel immunotherapies that prolong disease-free and overall survival, without harming health or quality of life. We thank all our stakeholders for their continued support.

 

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on May 17, 2024