Century Therapeutics Reveals Phase 1 ELiPSE-1 Interim Results at ASCO 2024

Century Therapeutics has announced promising interim results from their ongoing Phase 1 ELiPSE-1 trial, exploring CNTY-101 for relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

CNTY-101 and Its Progress

CNTY-101 is an investigational CD19-targeting cell therapy derived from induced pluripotent stem cells (iPSCs). This therapy incorporates six precision gene edits through Century’s proprietary Allo-Evasion™ technology, enabling repeated doses without the need for continuous lymphodepletion. The Phase 1 ELiPSE-1 trial (NCT05336409) is a multicenter, open-label study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with R/R, CD19-positive B-cell malignancies.

Safety and Efficacy Findings

Preliminary findings from the dose escalation phase of the study suggest that CNTY-101 has a manageable safety profile. Notably, there were no observed dose-limiting toxicities (DLTs) or graft-versus-host disease (GvHD). The majority of treatments were administered in an outpatient setting, reinforcing the safety and feasibility of CNTY-101 as an outpatient therapy.

Dose Escalation and Patient Responses

The ELiPSE-1 study is currently enrolling patients at Dose Levels 3B (three weekly infusions of one billion cells) and 4A (a single infusion of three billion cells). The interim data cutoff on March 27, 2024, showed that CNTY-101, administered in doses up to one billion cells per cycle, demonstrated a favorable safety profile. Among the 12 subjects who received at least one treatment cycle, there was no report of GvHD or DLTs, and eight subjects were treated in an outpatient setting.

In terms of efficacy, preliminary assessments in ten evaluable patients revealed a complete response rate (CRR) of 30% and an objective response rate (ORR) of 40% in heavily pretreated patients. Specifically, in the five patients treated with the two higher dosage levels, a CRR of 40% and an ORR of 60% were reported.

Pharmacokinetic Insights

Pharmacokinetic evaluation using a novel cell-free DNA (cfDNA) method indicated that CNTY-101 rapidly exits the circulation and persists outside the bloodstream. The area under the curve (AUC) for the therapy increased with higher dose levels. Additionally, among patients who received additional cycles without lymphodepleting chemotherapy, three out of four showed detectable levels of CNTY-101 on Day 3 and beyond.

Future Directions

Adrienne Farid, PhD, Chief Operations Officer and Head of Early Development, expressed optimism about the potential of CNTY-101. The ongoing dose escalation phase will transition to dose expansion in the coming months, aiming to support the therapy's viability for broader applications.

About CNTY-101 and Allo-Evasion™ Technology

CNTY-101 is Century’s flagship iNK cell therapy, featuring six precision gene edits for targeting CD19+ B cells and includes an EGFR safety switch for controlled elimination if necessary. The Allo-Evasion™ technology incorporated into CNTY-101 aims to evade host immune rejection, allowing for repeated dosing without rejection.

Century Therapeutics’ Commitment

Century Therapeutics is dedicated to developing innovative iPSC-derived cell therapies for cancer, autoimmune, and inflammatory diseases. Their expertise in cellular reprogramming and genetic engineering positions them to advance the field of cell therapy, potentially overcoming the limitations of first-generation therapies and expanding patient access to effective treatments.

Conclusion

The interim results from the ELiPSE-1 study are promising, indicating that CNTY-101 has a manageable safety profile and encouraging efficacy in heavily pretreated patients. With ongoing dose escalation and planned dose expansion, Century Therapeutics continues to advance the development of this innovative cell therapy.

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