Allogene Therapeutics Strengthens Partnership with Foresight Diagnostics to Support Development Efforts Beyond the US in Europe, the UK, Canada, and Australia
Wednesday, February 26, 2025
Allogene Therapeutics, Inc. a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) therapies for cancer and autoimmune diseases, has broadened its partnership with Foresight Diagnostics, Inc. This expansion will support the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) who may benefit from treatment with cemacabtagene ansegedleucel (cema-cel).
Under the updated agreement, both companies will work together to develop Foresight’s MRD assay as a companion diagnostic in the EU, UK, Canada, and Australia. This initiative aligns with Allogene’s clinical research on cema-cel, which is currently being evaluated in the pivotal ALPHA3 trial. The study aims to improve cure rates for LBCL by identifying patients who, despite achieving remission after initial treatment, still test positive for MRD. These patients, at high risk of relapse, will have the option to receive cema-cel as a one-time consolidation treatment to prevent disease recurrence.
As part of the agreement, Allogene will invest approximately $37.3 million for MRD assay development, milestone payments related to regulatory submissions in the US and certain international markets, and clinical sample testing. Both companies will work towards securing regulatory approvals and executing the agreed-upon development plan.
Cema-cel is an advanced anti-CD19 AlloCAR T™ investigational therapy for LBCL. The US Food and Drug Administration granted it Regenerative Medicine Advanced Therapy (RMAT) designation in June 2022 for relapsed or refractory LBCL. The ALPHA3 Phase 2 trial, which investigates its use as a first-line consolidation treatment, commenced in June 2024. Allogene holds oncology rights for cema-cel in the US, EU, and UK, with options to extend these rights to China and Japan.
Each year, over 60,000 patients in the US, EU, and UK undergo treatment for LBCL. While first-line chemoimmunotherapy such as R-CHOP is effective for many, around 30% of patients experience relapse and require further treatment. The current standard approach following first-line therapy has been to monitor patients for signs of relapse. The ALPHA3 study seeks to introduce cema-cel as a readily available, one-time treatment administered immediately after MRD detection following six cycles of R-CHOP or similar therapies. This approach positions cema-cel as a potential new standard of care for eligible patients with MRD.
Source: allogene.com
