Nature Medicine Study Validates PredicineBEACON™ MRD Liquid Biopsy Assay in Genentech’s Phase 1b Clinical Trial of Divarasib Plus Cetuximab in CRC

HAYWARD, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) — Predicine, Inc., a leading molecular insights company, announced a significant clinical milestone with the new publication of Genentech’s Divarasib plus Cetuximab study in Nature Medicine. This study validates the clinical utility of PredicineBEACON™, a personalized minimal residual disease (MRD) liquid biopsy assay, in reinforcing Genentech’s Phase 1b clinical trial of Divarasib plus Cetuximab in colorectal cancer (CRC). This study exemplifies Predicine’s continued leadership in the realm of liquid biopsy technology innovation and MRD. Building on the success of Genentech’s phase 1 trial of single-agent Divarasib (GDC-6036), a covalent KRAS G12C inhibitor, in non-small cell lung cancer (NSCLC) and CRC, previously published in the New England Journal of Medicine (NEJM), PredicineBEACON™ continues to play an important role in evaluating treatment efficacy of Divarasib plus Cetuximab combo therapy and identifying drug resistance mechanisms at the MRD level. Overcoming the intrinsic challenge of tissue-informed MRD assays, PredicineBEACON™ utilizes either tumor tissue or liquid biopsy (such as blood or urine) at baseline for exome-wide variant profiling prior to its subsequent personalized MRD tracking, enabling precise molecular monitoring of genomic alterations and identification of emerging resistance mechanisms. The longitudinal assessment of circulating tumor DNA at the MRD level (~100,000X sequencing depth) robustly correlates with positive treatment response. Consistent with the outcomes of the prior Phase 1 clinical trial, PredicineBEACON™ showcased remarkable biomarker results in the Phase 1b clinical trial of Divarasib Plus Cetuximab in CRC patients. A decline in KARAS G12C variant allele frequency was associated with treatment response, observed as early as CID15 in responsive patients. Using baseline, on-treatment, and end-of-treatment plasma samples, out of the 14 patients profiled, 13 (92.9%) exhibited at least one acquired genomic alteration linked with treatment resistance. The enhanced antitumor activity observed in this study reinforces the clinical utility of liquid biopsy profiling in evaluating the Phase 1b clinical trial of combined therapy in CRC patients. “MRD represents the next chapter of precision medicine. A major limitation of our current MRD assays is that they often depend on tumor tissue for baseline variant profiling. However, obtaining adequate tissue is frequently a challenge in the clinical setting due to insufficient materials or suboptimal sample quality,” said Dr. Josh Meeks, Associate Professor of Urology, Biochemistry, and Molecular Genetics at the Northwestern University Feinberg School of Medicine, who was not involved in this study. “The use of liquid biopsy samples at baseline and the progression of disease for real-time genomic profiling, personalized MRD tracking, and the identification of resistance mechanisms in this study is really at the unprecedented MRD level. This is a game-changing technology. A Liquid biopsy-informed MRD approach is particularly relevant in the neoadjuvant setting, and further supports organ preservation strategies without the necessity of invasive biopsies.” “We are thrilled to announce this significant clinical milestone that further validates the clinical impact of PredicineBEACON™ MRD testing in precision clinical trials.” said Dr. Shidong Jia, Founder & CEO of Predicine. “These landmark publications in prestigious medical journals such as NEJM and Nature Medicine stand as a testament to how Predicine’s unique and differentiating MRD liquid biopsy solution may advance the development of clinical trials, especially at Phase 1 setting”. The Nature Medicine publication can be found online at: https://www.nature.com/articles/s41591-023-02696-8 The NEJM publication can be found online at: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2303810?articleTools=true About Predicine Predicine is a leading molecular insights company committed to advancing precision medicine in oncology. Our commitment lies in developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy, empowering minimally invasive molecular diagnoses across various stages of disease management, including treatment selection, therapy response assessment, minimal residual disease (MRD) monitoring, and early cancer detection. The Predicine portfolio comprises state-of-the-art blood, urine, and tissue-based Next-Generation Sequencing (NGS) assays designed for harmonized global use in research, clinical investigation, and companion diagnostic (CDx) development. With operational hubs in Silicon Valley, Houston, Chicago, Shanghai, Beijing, and Suzhou, Predicine collaborates with leading biopharma companies, institutions, and governments in personalized healthcare on a global scale. For more information, please visit us on http://www.predicine.com and follow us on LinkedIn or Twitter (X). Contact Information: Predicine, Inc. [email protected]