Allogene Therapeutics has significantly expanded its strategic collaboration with Foresight Diagnostics through a $37.3 million investment aimed at advancing precision medicine in lymphoma treatment. The partnership focuses on developing Foresight's minimal residual disease (MRD) assay as a companion diagnostic for cemacabtagene ansegedleucel (cema-cel) therapy.
Strategic Development of Companion Diagnostic
The expanded agreement encompasses the development and regulatory approval of Foresight's MRD assay across multiple international markets, including the European Union, United Kingdom, Canada, and Australia. This diagnostic tool will play a crucial role in identifying suitable patients with large B-cell lymphoma (LBCL) for treatment with cema-cel.
The collaboration leverages Foresight's cutting-edge ctDNA-based Foresight Clarity investigational use only assay, which utilizes PhasED-Seq technology. This ultra-sensitive diagnostic approach aims to enhance patient selection and treatment monitoring capabilities.
ALPHA3 Trial Implementation
The MRD assay will be implemented in Allogene's groundbreaking ALPHA3 randomized controlled pivotal trial, which is evaluating cema-cel as a first-line treatment for LBCL patients. The trial's innovative approach involves using the diagnostic to identify patients who, despite achieving remission following initial treatment, remain MRD-positive.
Financial and Regulatory Commitments
The $37.3 million investment from Allogene encompasses several key components:
- MRD assay development funding
- Milestone payments for U.S. regulatory submissions
- Support for international regulatory applications
- Clinical sample testing costs
Both companies have committed to pursuing regulatory approvals for their respective products with commercially reasonable efforts. The partnership includes a detailed work plan to facilitate joint development activities and ensure successful implementation of the diagnostic platform.
