Anti-CD19 chimeric antigen receptor T cell therapy (Takara Bio)

Cancer Research UK (CRUK) and biotech company Aleta Biotherapeutics have entered into a collaboration on the early phase clinical development of Aleta’s blood cancer therapy candidate ALETA-001. ALETA-001 is a CAR-T cell engager candidate, which has been developed for the potential treatment of people with B-cell lymphoma and leukaemia whose disease has progressed following CD19 CAR-T cell therapy. Under the terms of the agreement, CRUK’s Centre for Drug Development will fund, sponsor and conduct the Phase I/IIa clinical trial of ALETA-001. This phase of development will be led by Dr Amit Patel’s Cellular and CAR-T therapies team at the Christie NHS Foundation Trust in Manchester, UK. The trial will enrol patients with B-cell lymphoma/leukaemia who have received CD19 CAR-T cell therapy but did not achieve a complete response or who relapsed from a complete response. When the recommended dose of ALETA-001 for Phase II development has been determined, Aleta will launch a multi-centre, single arm Phase II trial in the US focused on diffuse large B-cell lymphoma (DLBCL) patients. Aleta will also retain the rights to further develop and commercialise ALETA-001 and will receive a license to the results of the clinical trial conducted by CRUK in return for undisclosed milestone and royalty payments. “There is an urgent need to develop new therapies that can help people with B-cell cancers, such as lymphoma and leukaemia, whose cancer has progressed after treatment with CD19 CAR-T cell therapy,” said Paul Rennert, president, co-founder and chief scientific officer, Aleta Biotherapeutics. “Our collaboration with Cancer Research UK is a strong endorsement of the potential of our scientific platform to address the critical issues of CAR-T cell persistence, tumour antigen loss leading to patient relapse, and tumour antigen heterogeneity,” he added. “ALETA-001 uses a simple yet elegant method to redirect a patient’s circulating CD19 CAR-T cells against cancer cells expressing CD20, and we hope this could be a new treatment avenue for blood cancer. This is a landmark collaboration for Cancer Research UK as it’s the first-in-human trial for a new drug that reboots CAR-T cell therapy, and we look forward to progress its early clinical development with Aleta,” commented Nigel Blackburn, director of drug development at CRUK.