Ardena Supports Topas Therapeutics’ Nanoparticle-Based Immune Tolerance Therapies Advancing to Clinical Development

Ghent, Belgium, 13^th June 2025

A suite of nanoparticle-based immunotherapies developed by Topas Therapeutics has successfully progressed into clinical trials, supported end-to-end regarding Chemistry, Manufacturing, and Control (CMC) by Ardena, a specialist partner in the development and manufacturing of complex formulations and precision medicines.

Topas Therapeutics, based in Hamburg, Germany, is pioneering a highly differentiated and versatile approach to induce antigen-specific immune tolerance for the treatment of autoimmune and immune-mediated diseases. Central to this platform are Topas Particle Conjugates (TPCs)—polymer-coated iron oxide nanoparticles conjugated with disease-relevant peptides.

Ardena has provided a fully integrated suite of services to support the development and clinical manufacturing of these nanoparticle-based therapeutics. This collaboration encompasses synthetic route design, scale-up and GMP manufacturing, analytical method development, bioanalytical development and evaluation, and clinical supply, including packaging, labeling, and batch certification.

The scope of Ardena’s work includes the multistep preparation of a series of different TPCs: from iron oleate complex and polymer synthesis to SPION manufacture, surface coating, peptide conjugation, and final formulation. These sophisticated materials were manufactured to GMP standards, and Ardena has supplied both preclinical and clinical batches supporting a range of Topas’ programs.

Among these, TPM502 has demonstrated antigen-specific immune tolerance against gluten in celiac disease in a Phase 2a trial, achieving ”favourable safety profile and providing clinical proof of concept. TPM203 underwent investigation in a Phase 1 trial in pemphigus vulgaris, during which no safety concerns emerged and TPM203 rapid clearance from circulation was shown. “This long-term collaboration exemplifies Ardena’s strength in translating innovative nanomedicine concepts into clinical-grade materials,” said Jeremie Trochu, CEO of Ardena. “We provide not only the technical capabilities but also the flexibility and scientific insight required to support pioneering biotech companies like Topas Therapeutics.”

Hugo Fry, CEO of Topas Therapeutics, commented: “Progressing our immune tolerance candidates into the clinic is a significant milestone for Topas. Ardena’s broad capabilities and pragmatic approach have supported us throughout this journey, enabling the successful manufacture of our innovative particle conjugates and helping advance our clinical programs.”

The success of this collaboration highlights the importance of deeply integrated development strategies in the advancement of innovative therapeutic modalities and precision medicines.