Century Therapeutics Announces Investigator-Initiated Phase 1/2 Trial of its iPSC-derived iNK Cell Therapy CNTY-101 in B-cell Mediated Autoimmune Diseases Sponsored by Internationally Renowned Key Opinion Leaders
- Investigator-initiated trial (IIT) to be led by pioneers of cell therapy in B-cell mediated autoimmune disease, the Schett/Mackensen group at Friedrich-Alexander University Erlangen-Nürnberg -
- Trial to evaluate and enhance clinical experience with CNTY-101 in patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis -
PHILADELPHIA, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (NASDAQ:IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune disease, has entered into an agreement for an investigator-initiated Phase 1/2 trial by Professors Georg Schett and Andreas Mackensen of its CD19 CAR-iNK investigational cell therapy candidate CNTY-101 in patients with B-cell mediated autoimmune diseases. The IIT, which is sponsored by the Friedrich-Alexander University Erlangen-Nürnberg, represents the first evaluation by the internationally recognized Schett/Mackensen group of an allogeneic iPSC-derived CD19-directed NK cell therapy for the treatment of autoimmune diseases.
Consistent with Century's ongoing Phase 1 CALiPSO-1 trial (NCT06255028), the IIT (known as the CARAMEL trial) will evaluate safety, efficacy, and key translational data of CNTY-101 in systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis.
"The decision by these internationally recognized experts to conduct their first evaluation of allogeneic iPSC-derived cell therapies in autoimmune indications with Century represents important recognition of the unique potential for CNTY-101 in this setting. We believe CNTY-101 is well positioned to address autoimmune diseases as an iPSC-derived NK cell therapy incorporating our Allo-EvasionTM technology for precise control over drug exposure, as supported by pre-clinical and clinical data demonstrating clear anti-B cell activity and an encouraging safety profile. We look forward to insights from Dr. Schett and Mackensen's research into Century's allogeneic iNK cell therapy to complement and enhance clinical experience in our ongoing Phase 1 CALiPSO-1 trial of CNTY-101, setting us up for important milestones in the year ahead," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics.
Dr. Andreas Mackensen, Director of Medical Clinic 5 – Hematology & Internal Oncology at Friedrich-Alexander University Erlangen-Nürnberg, commented: "We believe allogeneic iPSC-derived cell therapy with a consistent, off-the-shelf product like CNTY-101 holds immense promise in the treatment of autoimmune diseases, driven by the elimination of logistical hurdles such as apheresis, removal of washout concerns, and the potential for administration in outpatient settings. We look forward to our partnership with Century on this study as we seek to address significant unmet needs for patients across these serious diseases."
The Schett/Mackensen group at Erlangen has pioneered the development of cell therapy in autoimmune diseases, having first presented data in 20221 showing that autologous CD19 CAR-T cell therapy achieved deep depletion of B-cells in patients with severe autoimmune disease leading to groundbreaking clinical outcomes. Their data continues to provide evidence of long-term, drug-free remission, and has paved the way for broader clinical investigation of cell therapies in these indications. The CARAMEL trial with Century is intended to commence in mid-2025 following CTA approval.
In addition to the Schett/Mackensen CARAMEL trial, the company plans also to expand the CALiPSO-1 clinical trial to include sites in select European countries. Century will provide timing on initial clinical data from its ongoing CALiPSO-1 clinical trial once a clear cadence of patient enrollment has been established across indications.
About Century Therapeutics
Century Therapeutics (NASDAQ:IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to autoimmune diseases. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer and autoimmune disease care. For more information on Century Therapeutics please visit www.centurytx.com.
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1 Mackensen Nature Medicine 2022 doi.org/10.1038/s41591-022-02017-5
