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Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.
Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, and NorthX Biologics, a contract development and manufacturing organization that serves as the National Swedish Innovation Hub for the good manufacturing practice (GMP) manufacture of biologics used in vaccines, gene therapies, and other advanced medicinal products, announced a manufacturing alliance on June 8, 2023. The companies will co-establish cell therapy manufacturing capabilities in Sweden for use in late-stage development and commercial manufacturing of Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.
In conjunction with this collaboration, Mendus has also entered into an agreement with Flerie Invest, a Swedish investment firm specializing in pharma and biotech companies, who will invest approximately $8.4 million in support of the alliance. According to a company press release, this investment will allow Mendus and NorthX to construct a cell therapy facility for the large-scale production of vididencel. In return, Flerie will receive an unspecified amount of shares in Mendus. Ted Fjällman, CEO of Flerie, is expected to join Mendus’ Board of Directors, subject to shareholder approval.
According to the release, vididencel is currently being evaluated in a Phase II clinical study for treatment of acute myeloid leukemia. Mendus plans to soon launch further clinical studies for this indication, and is also evaluating the vaccine as a treatment for ovarian cancer.
“Establishing large-scale manufacturing is a key element of our development strategy for vididencel,” said Erik Manting, CEO, Mendus, in the release. “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.”
“This strategic alliance not only paves Mendus’ path to commercializing vididencel for the benefit of cancer patients, but ensures NorthX strengthens its positioning as the premier GMP manufacturing hub for advanced therapies in the Nordics, attracting regenerative medicine innovators worldwide,” said Helena Strigård, CEO, NorthX, in the release. “We are proud to be working with Mendus to hone both teams’ skills in this rapidly developing area of cell therapies.”