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UK Regulator Grants ‘Innovation Passport’ Status to ALETA-001 for NHL, ALL


The U.K. Medicines and Healthcare products Regulatory Agency granted an Innovation Passport under the Innovative Licensing and Access Pathway for ALETA-001 in the treatment of patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia who failed to respond or relapsed after CD19 chimeric antigen receptor (CAR) T-cell therapy.

CAR T-cell therapy engager candidate ALETA-001 is an off-the-shelf preclinical biologic program developed to treat and prevent cell therapy relapse of existing CD19-targeted CAR T-cell therapies.

ALETA-001 is expected to enter clinical development in 2023 with Cancer Research UK’s Centre for Drug Development sponsoring and conducting a phase I/IIa clinical trial.

Source: BusinessWire, November 2022

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