Cancer Research UK is working with immuno-oncology company Aleta to advance the company’s CAR-T therapy into clinical trials.
Cancer Research UK will fund, sponsor and conduct the first phase 1 / 2a human clinical trial of Aleta’s CAR-T cell engagement candidate, ALETA-001.
ALETA-001 is part of Aleta’s pipeline of therapies targeting blood cancers and solid tumors. It is developed to treat people with B cell lymphoma and leukemia whose disease has progressed after receiving CD19 CAR-T cell therapy. If released to the market, ALETA-001 could offer an alternative therapy for patients with limited treatment options.
CAR-T cell therapy involves reprogramming a patient’s T cells in a lab so that they can recognize cancer cells and kill them. T cells taken from patients are designed to carry a specific CD19 receptor on their surface, allowing them to target cancer cells and kill them by binding the CD19 antigen found on B-cell leukemia and lymphoma cells.
It is believed that more than half of patients treated with CD19 CAR-T cell therapy relapse due to reduced or loss of CD19 expression. ALETA-001 works by binding to CD20 proteins found on the surface of cancer cells. This allows therapy to reactivate the CD19 CAR-T cells by “coating” the cancer cell with the target CD19 proteins and restoring the ability of the CAR-T cells to recognize and kill the cancer cell.
Paul Rennert, President, Co-Founder and Scientific Director of Aleta Biotherapeutics, said: “We are deeply honored to partner with Cancer Research UK to rapidly advance our lead drug candidate, ALETA-001, in the clinic. There is an urgent need to develop new therapies that can help people with B cell cancers, such as lymphomas and leukemias, whose cancer has progressed after treatment with CD19 CAR-T cell therapy. 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, loss of tumor antigen leading to patient relapse and heterogeneity of tumor antigen. We look forward to working with Cancer Research UK’s exceptional network of investigators and experienced researchers to conduct the trial.
In this new trial, patients with B cell lymphoma / leukemia who received CD19 CAR-T cell therapy but did not achieve a complete response or who relapsed after a complete response will be included. Once the recommended phase 2 dose of ALETA-001 has been determined, Aleta will initiate a pivotal, multi-center, single-arm phase 2 trial in the United States focusing on patients with diffuse large B-cell lymphoma ( DLBCL). This clinical trial will be designed to support the potential accelerated approval of ALETA-001.
Nigel Blackburn, Director of Drug Development at Cancer Research UK, said: “CAR-T cell therapy has transformed the treatment of patients with difficult-to-treat blood cancers, but many will see their cancer come back and treatment options will begin. to run out. ALETA-001 uses a simple but 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 avenue of treatment for blood cancer. This is a landmark collaboration for Cancer Research UK as it is the first human trial for a new drug that revives CAR-T cell therapy, and we look forward to advancing its early clinical development with Aleta. “