Mendus Announces Large-Scale Vididencel GMP Production Milestone in Manufacturing Alliance with NorthX Biologics
Mendus AB (publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, today announced the successful establishment of large-scale GMP production of its lead product vididencel, as part of its manufacturing alliance with NorthX Biologics. The milestone represents a critical step in the advanced clinical development strategy across acute myeloid leukemia (AML) and chronic myeloid leukemia (CML).
“With the establishment of large-scale GMP production, we deliver on an important milestone for the vididencel program,” said Mendus Chief Executive Officer Erik Manting. “Reliable manufacturing is central to advance our clinical trials and go-to-market strategy in AML and CML. This milestone demonstrates the maturity of the vididencel production process and strength of our partnership with NorthX Biologics. It also reflects the execution focus that defines Mendus, as we continue to build clinical momentum.”
Mendus and NorthX Biologics entered a strategic manufacturing alliance for the large-scale production of vididencel in 2023. The successful establishment of GMP production confirms the robustness and reproducibility of the manufacturing process in a large-scale GMP environment. The result secures the supply of clinical-grade material to support Mendus’ advanced clinical development program and positions NorthX Biologics as a potential commercial supplier of vididencel.
“Achieving GMP readiness and delivering clinical-grade material for Mendus' advanced clinical pipeline is a shared success story rooted in trust and innovation,” said NorthX Biologics Chief Executive Officer Janet Hoogstraate. “This partnership has gone beyond traditional manufacturing. Through open, transparent collaboration, we have built not just a cell therapy infrastructure but mutual capabilities. Together, we have grown stronger, technically, operationally, and strategically.”
As a post-remission immunotherapy, vididencel is designed to activate anti-leukemic immune responses against residual disease while preserving health and quality of life. Following positive Phase 2 proof-of-concept data demonstrating durable clinical remissions in AML, Mendus is expanding clinical development of vididencel in AML and CML, according to the updated clinical strategy communicated on October 2, 2025. Securing consistent GMP supply is central to this plan and marks the transition of Mendus towards a late-stage, clinical execution-focused company.