SOPHiA GENETICS and Precision for Medicine Validate New Clinical Trial Assay at Biomarkers & CDx 2024

SOPHiA GENETICS and Boundless Bio are collaborating to enhance clinical trial enrollment for a new cancer therapy targeting oncogene-amplified cancers. SOPHiA GENETICS, a leader in data-driven medicine, and Boundless Bio, a biopharma company, began their partnership in 2022. Their joint efforts have focused on developing and implementing an extrachromosomal DNA (ecDNA) detection algorithm as a clinical trial tool to identify patients with ecDNA-amplified tumors using the SOPHiA DDM™ Platform.

The partnership involves Precision for Medicine, a clinical research organization specializing in precision medicine, which provides laboratory services accredited by CAP and certified by CLIA. These services assist Boundless Bio's POTENTIATE Phase 1/2 clinical trial by validating a proprietary workflow for patient sample processing.

Oncogenic alterations, such as mutations and fusions, frequently lead to malignant cell growth and cancer. While there are approved treatments for many oncogenic mutations, patients with oncogene amplification often do not benefit as much. Oncogenes can be amplified on chromosomes or ecDNA, which are cancer-specific, circular DNA fragments causing oncogene amplification in over 14 percent of cancer patients. Boundless Bio aims to address this through a novel therapeutic approach targeting ecDNA.

SOPHiA GENETICS and Boundless Bio have developed the ecDNA Solution (ECS) algorithm to detect ecDNA using routine clinical next-generation sequencing (NGS) data. ECS is the first clinical trial assay specifically for ecDNA and was created by SOPHiA GENETICS in line with FDA guidelines for Investigational Use Only Clinical Trial Assays (IUO CTA). SOPHiA GENETICS provides data and analytical support for the device in Boundless Bio's ongoing first-in-human POTENTIATE Phase 1/2 study of its lead ecDNA-directed therapy, BBI-355.

Peter Krein, Ph.D., Senior Vice President of Precision Medicine at Boundless Bio, emphasized the importance of this collaboration in accurately identifying patients with ecDNA-amplified tumors for the POTENTIATE trial of BBI-355. Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer at SOPHiA GENETICS, highlighted the significant role of the SOPHiA DDM™ Platform in advancing clinical trials through their partnership with Boundless Bio, potentially leading to significant clinical advancements for patients with ecDNA-driven oncogene-amplified cancers.

SOPHiA GENETICS offers a cloud-native platform for the computation, standardization, and analysis of genomic data, compatible with any leading NGS technology. The decentralized SOPHiA DDM™ Platform eliminates traditional lab approach barriers, enabling global access to major hospitals and academic centers. This technology facilitates the implementation of clinical diagnostics and streamlines market entry for pharmaceutical companies.

Precision for Medicine integrates scientific expertise and clinical trial excellence to provide crucial insights into patient biology. By adapting its diagnostic workflow to align with the SOPHiA DDM™ Platform, Precision for Medicine supports the POTENTIATE clinical trial. Results from participant biopsy sample testing will further evaluate the clinical activity of the investigational drug BBI-355 in specific patient groups.

Darren Davis, PhD, Senior Vice President at Precision for Medicine, noted that their collaboration with Boundless Bio and SOPHiA GENETICS has produced a novel, seamless platform for clinical trial testing. This platform improves the patient selection process, potentially accelerating the availability of new ecDNA-directed therapies to patients.

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