Aleta Biotherapeutics and Cancer Research UK’s Centre for Drug Development announce first patient dosed in ALETA-001 Phase 1/2 clinical trial in patients with relapsed/refractory B-cell malignancies

Aleta Biotherapeutics (Aleta), a clinical stage, immuno-oncology company with a CAR T-cell engager (CTE) platform that enables cell cancer therapies to work more effectively, and Cancer Research UK’s Centre for Drug Development, today announce the first patient was dosed in a Phase 1/2 clinical trial. This trial is evaluating the Company’s first-in-class biologic CAR T-cell engager, ALETA-001, for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19-targeting CAR T-cell therapy.

Cancer Research UK’s Centre for Drug Development is sponsoring and conducting the Phase 1/2 clinical trial of ALETA-001, the lead agent in Aleta's portfolio.

“It is very exciting and meaningful to have ALETA-001 now in the clinic. Clinical evaluation of ALETA-001 is a key milestone toward a much-needed treatment option for the many cancer patients whose CD19-targeted CAR T-cell therapies ultimately stop working. ALETA-001 restores and increases the effectiveness with which CAR T-cells can kill cancer cells, and we believe that it will enable more patients to successfully benefit from cell therapies,” stated Dr Paul Rennert, President and Chief Scientific Officer, Aleta Biotherapeutics.

The ALETA-001 Phase 1/2 clinical trial is an open-label, dose-expansion trial which will evaluate safety and tolerability, pharmacokinetic and pharmacodynamic effects, and early signals of clinical efficacy of ALETA-001 as a single agent. Chief Investigator Dr Sridhar Chaganti is leading the trial from University Hospitals Birmingham NHS Foundation Trust in Birmingham, UK, and will enrol patients who are relapsed/refractory following treatment with available CD19-targeting CAR T-cell therapies. For more information on this trial, please visit clinicaltrials.gov (NCT06045910).

Dr Lars Erwig, Cancer Research UK’s Director of Drug Development, said, “A significant number of patients with blood cancers unfortunately relapse following CD19-directed CAR T-cell therapy. ALETA-001 is being developed to provide patients with these cancers a better chance for a successful treatment outcome. At Cancer Research UK, we are very excited to study the clinical potential of ALETA-001 to transform a patient’s treatment journey – which can possibly be lifesaving in many cases.”

“Aleta-001 is a uniquely designed new molecule with a novel mechanism of action, coating tumour cells densely with the target antigen, thereby stimulating the tumour killing ability of activated CAR T-cells,” commented Dr Sridhar Chaganti, Chief Investigator, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. “This is an important new strategy being investigated to improve outcomes for patients with relapsed or refractory lymphomas who experience disease progression after CAR T-cell therapy and have a poor prognosis.”