Mendus AB

Mendus and NorthX Biologics to enter into strategic cell therapy manufacturing alliance supported by new investor Flerie

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announces that it has entered into a manufacturing alliance with NorthX Biologics AB (“NorthX”). NorthX is a Contract Development and Manufacturing Organization (CDMO) and serves as the National Swedish Innovation Hub for the GMP manufacture of biologics used in vaccines, gene therapy and other advanced therapy medicinal products (ATMPs). Mendus and NorthX will co-establish cell therapy manufacturing capabilities in Sweden, which will be used for late-stage development and commercial manufacturing of Mendus’ lead asset vididencel.

In conjunction with the NorthX collaboration, Mendus has entered into an agreement with Flerie Invest AB (“Flerie”), a leading Swedish investment firm. Flerie will initially invest SEK 90 million in Mendus to support the NorthX alliance. With the investment, Mendus and NorthX will collaborate to realize a cell therapy facility to be used for the large-scale manufacturing of Mendus’ lead program vididencel. The planned investment is scheduled to cover all necessary activities until Q2 2025, including adjustments to current NorthX facilities, tech transfer of the vididencel manufacturing process and manufacturing of vididencel batches for a pivotal-stage clinical trial. Following the successful completion of the financing transaction, Flerie will join Van Herk Investments and the Fourth Swedish National Pension Fund (AP4) as a major Mendus shareholder. Ted Fjällman, Chief Executive Officer at Flerie, is expected to join Mendus’ Board of Directors, subject to shareholder approval. The collaboration with NorthX and the investment by Flerie are part of a larger financing transaction of Mendus, which will be announced through a separate press release, and is conditional upon approval by an Extraordinary General Meeting, expected to be held on July 10, 2023.

Mendus has established a rich pipeline of innovative cell-based immunotherapy product candidates focused on delaying or preventing tumor recurrence, the main cause of death of cancer patients today. Vididencel is currently being evaluated in the ADVANCE II Phase 2 clinical study in Acute Myeloid Leukemia (AML) with patients in long-term follow up. Interim results on the primary and secondary endpoints of the study have demonstrated vididencel’s potential to treat minimal residual disease, improve the immune status of patients, and result in relapse-free and overall survival benefits. The company is preparing to advance vididencel into late-stage and pivotal-stage development with a second Phase II in AML maintenance, a combination study with standard of care, planned for H2 2023. In addition to hematological malignancies, Mendus is evaluating vididencel in ovarian cancer to translate the therapeutic strategy into the treatment of solid tumors.