Century Therapeutics announced that the company has been notified by the U.S. Food and Drug Administration (FDA) that the company's Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe systemic lupus erythematosus (SLE) who have failed at least two standard immunosuppressive therapies. This represents the first Investigational New Drug (IND) application clearance for an autoimmune and inflammatory disease indication for CNTY-101, and is built on the emerging data and experience gained from administering multiple cycles of CNTY-101, with and without lymphodepletion, under the open IND for CNTY-101 in relapsed/refractory B-cell malignancies. Despite recent advances, therapies for SLE have failed to make a significant impact on morbidity, and induction of remission remains rare, while treatment toxicity and disease flares are common.

B-cell-directed autologous CAR T cell therapies have provided new hope for durable remissions through an ?immune reset?. However, some of the challenges encountered with auto-CAR-T in oncology related to product availability, toxicities, and potential long-term risks could hamper their wide-spread adoption in non-oncology indications. Century is pursuing an alternative approach with CNTY-101, an allogeneic, off-the-shelf iPSC-derived NK cell product candidate.

CNTY-101 contains 6 genetic edits at defined loci, engineered via homology directed repair using CRISPR. These include three Allo-Evasion? edits, secreted IL-15, a CD19 CAR, and a safety switch allowing for cell removal if required.

As a homogenous NK cell candidate derived from a single iPSC clone, CNTY-101 has been designed with uniquely engineered features which Century believes may provide multiple potential treatment advantages. These potential advantages include availability of a consistent off-the-shelf frozen product, an improved tolerability profile, ability to be re-dosed without lymphodepletion while avoiding allo-rejection of the product, and a product design that may enable the elimination of B cells to effect a decline in auto-antibodies without prolonged B cell aplasia. The multi-center Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and clinical response of CNTY-101 in patients with moderate to severe SLE who have failed at least two standard immunosuppressive therapies.

The trial will evaluate one to two cycles of 3 weekly doses of CNTY-101, with lymphodepletion only included prior to the first CNTY-101 infusion. The company plans to initiate the trial in the first half of 2024, with initial data expected by the end of 2024.