Aleta Biotherapeutics Receives Innovation Passport Designation for Biologic CAR T-Cell Therapy Engager ALETA-001
Tuesday, November 08, 2022
Aleta Biotherapeutics (Aleta), a privately owned company specializing in immuno-oncology, has received positive news regarding its innovative CAR T-cell therapy Engager candidate, ALETA-001. The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta an Innovation Passport through the Innovative Licensing and Access Pathway (ILAP). This passport allows Aleta to pursue the development and potential use of ALETA-001 for the treatment of patients with B-cell malignancies, specifically non-Hodgkin lymphoma (NHL) and Acute Lymphoblastic Leukemia (ALL). The treatment is intended for patients who have not responded to or have relapsed after CD19 CAR T-cell therapy. ALETA-001 is scheduled to enter clinical development in 2023, with the support and sponsorship of Cancer Research UK's Centre for Drug Development. The center will oversee a Phase 1/2a clinical trial.
The Innovation Passport serves as the initial stage in the ILAP process. It prompts the MHRA and its partner agencies, including The All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC), to create a regulatory and development roadmap. This roadmap aims to expedite patient access to medications in the U.K. To receive an Innovation Passport, a medicine must address life-threatening or severely debilitating conditions, and there must be a significant existing need within the patient or public health domain.
Paul Rennert, Co-Founder, Acting Chief Executive Officer, and Chief Scientific Officer of Aleta Biotherapeutics, expressed the significance of this designation for their biologic CAR T-cell therapy engager, ALETA-001. Rennert stated that it represents a crucial milestone in addressing the urgent requirements of patients who experience relapses or disease progression after CD19-targeted CAR T-cell therapy for blood cancers like lymphoma and leukemia. Aleta Biotherapeutics and its partner, Cancer Research UK, are thrilled to advance ALETA-001 and potentially transform the lives of patients afflicted with blood cancers.
Dr. Nigel Blackburn, Cancer Research UK's Director of Drug Development, highlighted the importance of receiving the designation for ALETA-001. The therapy acts as a bridge between a patient's circulating CD19-targeted CAR T-cells and cancer cells expressing CD20, offering a promising solution for patients whose cancer returns following CAR T-cell therapy. Despite the groundbreaking impact of CAR T-cell therapy on the outcomes of challenging blood cancers, a majority of patients experience cancer relapse. ALETA-001 aims to address this treatment gap and provide effective options for patients who currently lack them.
Aleta Biotherapeutics and Cancer Research UK announced their collaboration in June 2021. As part of this collaboration, Cancer Research UK's Centre for Drug Development will fund, sponsor, and conduct the first-in-human Phase 1/2a clinical trial of ALETA-001. The trial will be led by Dr. Sridhar Chaganti's team specializing in Cellular and CAR T-cell therapies at the Queen Elizabeth Hospital and University Hospitals Birmingham NHS Foundation Trust in Birmingham, UK. The trial will enroll patients with B-cell lymphoma or leukemia who have undergone CD19-targeted CAR T-cell therapy but did not achieve a complete response or experienced relapse from a complete response. Aleta retains all rights to further develop and commercialize ALETA-001.
