Genialis, the RNA biomarker company, announced the commercial availability of Genialis™ krasID, the first biomarker algorithm that can predict patient response and clinical benefit to KRAS inhibitors (KRASi) across tissue histology and mutation type. Genialis krasID can help guide drug development from early preclinical phases (e.g., compound/MOA differentiation and selection), to clinical trials (e.g., patient selection for clinical trials and identification of combination therapies), to market access and clinical care (e.g., development of CDx and as a clinical decision tool). Genialis first revealed the potential of krasID at AACR 2024, and since, under its early access program, has engaged numerous top pharmaceutical companies and biotechs to evaluate the biomarker for their development programs.
KRAS mutations contribute to approximately 1.6 million new cancer cases globally each year, predominantly in non-small cell lung and colorectal cancers and pancreatic ductal adenocarcinoma. More than 65 companies are developing an estimated 100 KRASi therapies across 18 indications. However, patient response rates to KRASi remain modest, with only about 30-40 percent showing benefit, and then for only 6-10 months duration. Today, KRAS-eligible patients are selected solely on mutation status, an outmoded biomarker strategy that provides virtually no insight into which patients will respond to treatment and for how long.
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“What if I told you we could predict with 85 percent, 90 percent, or even 95 percent precision which patients are going to benefit from a new therapy? And we could tell you how long that benefit will last? And we could specify which patients should receive a given combination of drugs?” said Rafael Rosengarten, Ph.D., chief executive officer of Genialis. “Genialis krasID is a new kind of biomarker that aims to provide exactly this deep insight into each patient’s biology, with the latest data showing promising performance across all major KRAS indications.”
Genialis krasID uses machine learning (AI/ML) to model dozens of biological processes from the gene expression of patient-derived tumors, providing incomparably more information and predictive power than traditional mutation-based diagnostics. It has been validated on real-world data from G12C non-small cell lung cancer (NSCLC) patients and on data from myriad preclinical and PDX samples across colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC), where it has shown pan-RAS, pan-tissue applicability.
“KRASi hold transformative potential for cancers like NSCLC, CRC, and PDAC, but for these drugs to achieve their full impact, we need better tools to understand who are the right patients,” said Mark Uhlik, Ph.D., vice president of biomarker development at Genialis. “Genialis krasID represents a significant leap forward in personalizing cancer care.”
Genialis will present new data on krasID at its seminar at the 6th Annual RAS-Targeted Drug Development Summit in Boston on September 25, 2024.
SOURCE: Businesswire