SOPHiA GENETICS has announced the validation of its novel clinical trial assay, developed in collaboration with Boundless Bio and Precision for Medicine, at the World Clinical Biomarkers & CDx 2024 event. The assay is designed to identify patients with oncogene-amplified cancers driven by extrachromosomal DNA (ecDNA) for enrollment in Boundless Bio's POTENTIATE Phase 1/2 clinical trial, evaluating the ecDNA-directed therapy (ecDTx), BBI-355. This collaboration leverages SOPHiA GENETICS' SOPHiA DDM™ Platform and Precision for Medicine's laboratory services to streamline patient selection and accelerate clinical development.
Addressing Oncogene Amplification with ecDNA Detection
Oncogene amplification, a key driver of malignant cellular growth, often leads to cancer. While targeted therapies exist for oncogenic mutations and fusions, patients with oncogene amplification, particularly those involving ecDNA, typically do not benefit from these treatments. ecDNA, circular fragments of DNA outside chromosomes, are a root cause of oncogene amplification in over 14% of cancer patients. Boundless Bio is targeting ecDNA as a novel therapeutic approach for these cancers.
The ecDNA Solution (ECS) Algorithm
SOPHiA GENETICS and Boundless Bio have jointly developed the ecDNA Solution (ECS) algorithm to detect ecDNA using routine clinical next-generation sequencing (NGS) data. ECS, designed as an Investigational Use Only Clinical Trial Assay (IUO CTA) in accordance with FDA guidelines, is the first ecDNA clinical trial assay. SOPHiA GENETICS provides data and analytical support for ECS in Boundless Bio's POTENTIATE study, a first-in-human trial of BBI-355.
Precision for Medicine's Role
Precision for Medicine is supporting the POTENTIATE clinical trial by adapting its diagnostic workflow to ensure seamless integration with the SOPHiA DDM™ Platform. The analysis of biopsy samples from POTENTIATE trial participants will provide further insights into the clinical activity of BBI-355 in specific patient populations. This collaboration aims to improve patient selection accuracy and accelerate the development of ecDNA-directed therapies.
Expert Perspectives
Peter Krein, Ph.D., Senior Vice President of Precision Medicine at Boundless Bio, emphasized the importance of the ECS in identifying patients with ecDNA-amplified tumors for the POTENTIATE clinical trial. Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS, expressed excitement about contributing to clinical advances for patients with ecDNA-driven oncogene-amplified cancers. Darren Davis, PhD, Senior Vice President, Precision for Medicine, highlighted the unique platform generated through the collaboration, enabling a new model for clinical trial testing.
