FDA Announced Clearance To Century Therapeutics' Allogeneic Cell Therapy Candidate Study

Century Therapeutics, Inc. IPSC received ELiPSE-1 clinical study may proceed notification from the U.S. Food and Drug Administration (FDA) to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies.

The ELiPSE-1 study is a Phase 1 trial designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell malignancies.

CNTY-101 is the first Allogeneic Cell Therapy product candidate engineered to overcome three major pathways of host vs graft rejection.

All enrolled patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days.

Lalo Flores, Chief Executive Officer, commented: “This IND clearance is a significant milestone for Century as we execute on our vision to merge two disruptive platforms, precision gene editing and the powerful potential of iPSCs, to potentially move the allogeneic cell therapy field forward, and continue on our path to becoming a leader in the space. We look forward to assessing the potential of Allo-Evasion to prevent immunological rejection and enhance persistence of multiple dosing of CNTY-101 regimens with the aim to increase the proportion of patients that achieve durable responses."

The company anticipates initiation of the Phase 1 trial later this year.

Price Action : Century Therapeutics shares are trading around 1 percent higher at $11.10 on Wednesday at the time of publication.