NorthX Biologics achieves milestone GMP certification to manufacture vididencel

Mendus’ lead cell therapy product for acute and chronic myeloid leukemias

• Off-the-shelf cellular immunotherapy for acute and chronic myeloid leukemias now ready to advance into upcoming late-stage clinical trials
• Strategic collaboration has enabled Mendus to accelerate its lead program, following positive Phase 2 proof-of-concept data
• Demonstrates value of tailored CDMO alliances and strengthens Sweden’s position as leading ATMP hub

Matfors, Sweden, 12 01 2025. NorthX Biologics, a leading CDMO and Swedish national innovation hub for advanced biologics, and Mendus (publ: IMMU.ST), a Swedish-Dutch immuno-oncology company developing cell-based immunotherapies to address tumor recurrence and improve survival outcomes, today announced the successful completion of GMP manufacturing certification for Mendus’ lead cell therapy product, vididencel.

This milestone marks the culmination of a transformative collaboration initiated in 2023, when NorthX Biologics and Mendus entered into a strategic alliance to establish scalable, GMP-compliant cell therapy manufacturing in Sweden. The project, co-financed by leading life science investor Flerie, was designed to support late-stage clinical development and future commercialization of vididencel, Mendus’ groundbreaking immunotherapy targeting tumor recurrence in AML and other cancers.

“This partnership has gone beyond traditional manufacturing,” said Janet Hoogstraate, CEO of NorthX Biologics. “Through open and transparent collaboration, we’ve built not only a cell therapy infrastructure but also mutual capabilities. Together, we’ve grown stronger, technically, operationally, and strategically. Achieving GMP readiness and delivering clinical-grade material for Mendus’ upcoming clinical trials is a shared success story rooted in trust and innovation.”

For two years, NorthX Biologics and Mendus have collaborated closely to adapt NorthX Biologics’ GMP facilities for allogeneic cell therapy production, perform tech transfer of the vididencel process, and manufacture clinical batches in accordance with stringent regulatory standards. The process development and manufacturing journey has reinforced Sweden’s position as a hub for advanced therapy medicinal products (ATMPs) and enabled Mendus to accelerate its oncology pipeline.

“With the establishment of large-scale GMP production, we’re delivering on an important milestone for the vididencel program,” said Mendus CEO 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 reflects the execution focus that defines Mendus, as we continue to build clinical momentum.”

The successful execution of this manufacturing project positions both companies at the forefront of Europe’s ATMP ecosystem. It also exemplifies how tailored CDMO alliances can unlock clinical and commercial potential for cell therapies by aligning scientific ambition with industrial excellence.

About NorthX Biologics
NorthX Biologics is a leading contract development and manufacturing organization (CDMO) and Sweden’s national innovation hub for advanced biologics, enabling next-generation therapies beyond traditional manufacturing. With over 30 years of GMP experience, NorthX Biologics offers end-to-end services including process development, recombinant proteins, vaccines, personalized medicine, viral vectors, cell therapies, and aseptic fill & finish. Headquartered in Matfors, Sweden, NorthX Biologics also operates a facility in Stockholm and a commercial office in Boston, USA, serving customers worldwide.
https://www.nxbio.com/

For more information, please contact:
Janet Hoogstraate
Chief Executive Officer
E-mail: janet.hoogstraate@nxbio.com

About Mendus

Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies that combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST.
www.mendus.com

For more information, please contact:
Erik Manting
Chief Executive Officer
E-mail: ir@mendus.com