Allogene to invest $37.3M in expanded MRD assay pact with Foresight Diagnostics

Allogene Therapeutics (ALLO) announced an expanded strategic collaboration with Foresight Diagnostics to include the development of Foresight’s minimal residual disease assay as a companion diagnostic to identify patients with large B-cell lymphoma for treatment with cemacabtagene ansegedleucel. Under the amended and restated strategic collaboration agreement, Allogene and Foresight will work together to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel. Cema-cel is being studied in the groundbreaking randomized controlled pivotal ALPHA3 trial as part of a first-line treatment to potentially improve the cure rate in patients with LBCL. In the ALPHA 3 trial, patients who achieve remission following initial treatment but remain positive for MRD will be identified by using Foresight Diagnostics’ ultra-sensitive ctDNA-based Foresight Clarity investigational use only assay, powered by PhasED-Seq. As part of this agreement, Allogene will invest approximately $37.3M for MRD assay development, milestone payments for U.S., and certain international regulatory submissions and clinical sample testing. Both companies have committed to use commercially reasonable efforts to obtain regulatory approvals of their respective products and execute the agreed-upon work plan to support and enable the joint development activities.