Aleta Biotherapeutics and Cancer Research UK's Centre for Drug Development Initiate First Patient Dosing in ALETA-001 Phase 1/2 Clinical Trial for Relapsed/Refractory B-Cell Malignancies
Thursday, February 22, 2024
Aleta Biotherapeutics (Aleta), a company specializing in immuno-oncology with a focus on CAR T-Cell Engager (CTE) platforms to enhance cancer therapies, in collaboration with Cancer Research UK’s Centre for Drug Development, has initiated dosing for the first patient in a Phase 1/2 clinical trial. This trial aims to assess the efficacy of their pioneering biologic CAR T-Cell Engager, ALETA-001, in treating patients with B-cell malignancies who have relapsed or shown refractory responses to CD19-targeting CAR T-cell therapy.
The Phase 1/2 clinical trial of ALETA-001 is being sponsored and conducted by Cancer Research UK’s Centre for Drug Development, with ALETA-001 being the leading agent in Aleta's product portfolio.
Aleta Biotherapeutics, expressed enthusiasm about this crucial milestone, emphasizing the potential of ALETA-001 to address the urgent need for effective treatments in cancer patients who have ceased responding to CD19-targeted CAR T-cell therapies. ALETA-001 is designed to enhance the killing efficacy of CAR T-cells against cancer cells, potentially widening the scope of patients who can benefit from cell therapies.
The trial, led by Chief Investigator Dr. Sridhar Chaganti from University Hospital Birmingham NHS Foundation Trust, UK, will focus on evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ALETA-001 as a standalone treatment. Patients eligible for enrollment are those who have relapsed or shown refractory responses after receiving CD19-targeting CAR T-cell therapies.
Dr. Lars Erwig, Director of Drug Development at Cancer Research UK, highlighted the significance of ALETA-001 in offering a renewed treatment avenue for patients who experience relapse post CD19-directed CAR T-cell therapy. He emphasized the potential of ALETA-001 to transform treatment outcomes, potentially saving lives.
Dr. Sridhar Chaganti, the Chief Investigator, underscored the innovative design of ALETA-001, which coats tumor cells with the target antigen, thereby enhancing the tumor-killing capabilities of activated CAR T-cells. This novel approach holds promise in improving outcomes for patients with relapsed or refractory lymphomas, addressing an unmet medical need.
ALETA-001, Aleta’s leading clinical program, is tailored for treating B-cell malignancies in patients at risk of treatment failure following CD19-directed CAR T-cell therapy. Engineered to augment the effectiveness of CD19-directed CAR T-cell therapies, ALETA-001 works by increasing CD19 antigen density and reinstating lost CD19 expression on cancer cells. By incorporating the CD19 target protein linked to a CD20 antibody domain, ALETA-001 enables easy recognition and elimination of CD19+/CD20+ cancer cells by previously administered CAR T-cells.
Aleta has garnered substantial clinical support and funding from Cancer Research UK for the Phase 1/2 trials of ALETA-001. Additionally, ALETA-001 has received a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). The ILAP designation is granted to medicines addressing life-threatening or severely debilitating conditions with significant patient or public health needs.
Source: businesswire.com
