Century Therapeutics, a biotechnology company focused on iPSC-derived cell therapies for immuno-oncology and autoimmune diseases, has announced a significant collaboration to advance its lead candidate, CNTY-101. The company has partnered with renowned experts Professors Georg Schett and Andreas Mackensen of Friedrich-Alexander University Erlangen-Nürnberg for an investigator-initiated Phase 1/2 trial (IIT) called the CARAMEL trial.

This IIT marks the first evaluation by the Schett/Mackensen group of an allogeneic (off-the-shelf) iPSC-derived CD19-directed NK cell therapy in autoimmune diseases. The CARAMEL trial will mirror Century’s ongoing Phase 1 CALiPSO-1 trial (NCT06255028) by assessing the safety, efficacy, and key translational data of CNTY-101 in several B-cell mediated autoimmune conditions: systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis.

Brent Pfeiffenberger, CEO of Century Therapeutics, emphasized the importance of this collaboration, stating that it validates the potential of CNTY-101 in autoimmune settings. He highlighted CNTY-101’s unique advantages as an iPSC-derived NK cell therapy incorporating Century’s Allo-Evasion™ technology, which allows for precise control over drug exposure. He also noted the encouraging preclinical and clinical data demonstrating anti-B cell activity and a favorable safety profile. The company anticipates valuable insights from the CARAMEL trial, which will complement their ongoing CALiPSO-1 trial and drive key milestones in the coming year.

Dr. Andreas Mackensen explained the rationale behind using allogeneic iPSC-derived cell therapy like CNTY-101, emphasizing the advantages of an “off-the-shelf” product. He pointed out the elimination of logistical challenges associated with autologous (patient-derived) cell therapies, such as apheresis (blood collection), the removal of washout periods (time needed for prior treatments to clear the system), and the potential for outpatient administration. Dr. Mackensen expressed enthusiasm for the partnership with Century and their shared goal of addressing significant unmet needs for patients with these serious autoimmune diseases.

The Schett/Mackensen group is a recognized leader in cell therapy for autoimmune diseases. Their 2022 research demonstrated the effectiveness of autologous CD19 CAR-T cell therapy in achieving deep B-cell depletion and inducing long-term, drug-free remission in patients with severe autoimmune conditions, paving the way for further investigation of cell therapies in this area. The CARAMEL trial with Century is expected to begin in mid-2025, pending clinical trial authorization (CTA) approval.

In addition to the CARAMEL IIT, Century plans to expand its CALiPSO-1 clinical trial to include sites in select European countries. The company will provide an update on the timing of initial clinical data from CALiPSO-1 once patient enrollment has stabilized across the different indications being studied.

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