Mendus AB, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, entered into a manufacturing alliance with NorthX Biologics AB. 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, a Swedish investment firm. Flerie will initially invest SEK 90 million in Mendus to support the NorthX alliance.

The planned investment includes adjustments to current NorthX facilities, tech transfer of the vididencel manufacturing process and manufacturing of vididencel batches for a pivotal-stage clinical trial. 

Mendus has established a pipeline of innovative cell-based immunotherapy product candidates focused on delaying or preventing tumor recurrence. 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 study results 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.

In addition to hematological malignancies, Mendus is evaluating vididencel in ovarian cancer to translate the therapeutic strategy into the treatment of solid tumors.

“Establishing large-scale manufacturing is a key element of our development strategy for vididencel,” said Erik Manting, CEO of Mendus. “The alliance with NorthX as Sweden’s emerging center of excellence for manufacturing of this drug class, supported by an investment by Flerie, is a major step for Mendus in this regard, as it brings together the required funding and the opportunity to establish a dedicated facility to manufacture vididencel for the next stage of clinical development and, eventually, commercialization.”

Helena Strigård, CEO of NorthX said, “This strategic alliance not only paves Mendus’ path to commercializing vididencel for the benefit of cancer patients but ensures NorthX strenghtens its positioning as the premier GMP manufacturing hub for advanced therapies in the Nordics, attracting regenerative medicine innovators worldwide. We are proud to be working with Mendus to hone both teams’ skills in this rapidly developing area of cell therapies.”