Aleta Biotherapeutics (Aleta), a pioneer in immuno-oncology with a focus on CAR T-Cell Engager (CTE) platforms, in collaboration with Cancer Research UK’s Centre for Drug Development, marks a significant milestone with the dosing of the first patient in a Phase 1/2 clinical trial. The trial evaluates Aleta’s groundbreaking biologic CAR T-Cell Engager, ALETA-001, for patients suffering from relapsed/refractory B-cell malignancies following CD19-targeting CAR T-cell therapy.

Cancer Research UK’s Centre for Drug Development spearheads the Phase 1/2 clinical trial of ALETA-001, representing a pivotal advancement in Aleta’s portfolio.

Dr. Paul Rennert, President, and Chief Scientific Officer of Aleta Biotherapeutics, expressed optimism about the clinical evaluation of ALETA-001, highlighting its potential to address a critical unmet need in cancer therapy. ALETA-001 offers a promising approach to enhance the efficacy of CAR T-cell therapies, particularly in patients where conventional treatments have faltered.

The ALETA-001 Phase 1/2 clinical trial, led by Chief Investigator Dr. Sridhar Chaganti of University Hospital Birmingham NHS Foundation Trust, aims to assess safety, pharmacokinetics, and early efficacy signals of ALETA-001 as a standalone therapy. Targeting patients with relapsed/refractory B-cell malignancies post-CD19-directed CAR T-cell therapy, this trial holds promise for enhancing treatment outcomes and improving patient prognosis.

Dr. Lars Erwig, Director of Drug Development at Cancer Research UK, emphasized the potential of ALETA-001 to transform treatment paradigms for patients facing relapsed/refractory blood cancers. The collaboration underscores Cancer Research UK’s commitment to driving innovation and delivering life-saving therapies to patients in need.

Dr. Sridhar Chaganti, Chief Investigator at University Hospital Birmingham NHS Foundation Trust, highlighted the unique mechanism of action of ALETA-001, heralding a new era in cancer therapy. By stimulating the tumor-killing ability of CAR T-cells, ALETA-001 presents a promising strategy to improve outcomes for patients with relapsed/refractory lymphomas.

The initiation of the ALETA-001 Phase 1/2 clinical trial signifies a significant step forward in the quest to combat relapsed/refractory B-cell malignancies, underscoring the collaborative efforts of Aleta Biotherapeutics and Cancer Research UK in advancing cancer treatment innovation.