Genialis, the RNA-biomarker company, today announced a new partnership with the Pancreatic Cancer Action Network (PanCAN) to expand the validation of the Genialis™krasID biomarker in the pancreatic cancer histology. Genialis krasID is a new Artificial Intelligence classifier that accurately predicts response and clinical benefit to KRAS inhibitors across preclinical, clinical, and real-world settings. The announcement was made today at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago from May 31 to June 4.
In the United States alone, roughly 150,000 patients every year are diagnosed with KRAS-mutated cancer. Overactivation of KRAS is implicated in up to 95 percent of pancreatic cancers, predominantly G12D, for which there are no approved drugs. Genialis krasID is a biologically complex RNA-based biomarker panel predictive of response and benefit of KRAS inhibitor therapies and is designed to work across histologies. This collaboration between Genialis and PanCAN will help advance Genialis krasID as a diagnostic tool to facilitate the development of much-needed new medicines and aid physicians and their patients in treatment planning.
“Pancreatic cancer is a tough disease with few treatment options, and currently the 5-year survival rate is 13 percent. By partnering with Genialis, we will lever the data from PanCAN’s Know Your Tumor precision medicine service to further validate Genialis krasID biomarker performance in pancreatic cancer,” said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. “Our goal is to accelerate the development of the new wave of KRAS-targeted therapies to improve outcomes for patients with pancreatic cancer.”
Most biomarkers in the KRAS space measure only KRAS mutation status, which may be necessary to receive the drug but is insufficient to predict or monitor response or to inform combinations or subsequent therapeutic interventions. By using high-dimensional gene expression data, Genialis krasID captures underlying biological complexity unique to each individual patient. In a poster at AACR in April 2024, the classifier predicted preclinical drug response with an accuracy of 0.94 Area Under the Receiver Operator Curve (AUROC) and identified real-world patient responders with an AUROC of 0.80. Kaplan-Meier analysis of the real-world sotorasib (LUMAKRAS) patient data considered time on treatment as an available proxy for progression-free survival. This analysis showed that patients classified as “krasID-high” had median time on treatment of almost one year (338 days), compared with those classified as “krasID-low” with median time on treatment of only 158 days (hazard ratio [HR] = 0.35, P-value = 0.009). Such patient stratification simply cannot be done with the DNA mutation-only biomarker. These early results demonstrate that the Genialis krasID classifier can predict response and stratify durable benefit in experimental and clinical settings.
“The RAS gene family is the original white whale of cancer drug targets. Since the discovery of RAS genes and their role in promoting cancer over 40 years ago, patients, physicians, and cancer researchers have been on the hunt for a safe and effective drug against this behemoth. Yet, there are still limited treatment options,” said Rafael Rosengarten, Ph.D., CEO of Genialis. “Nowhere is mutated KRAS more prevalent than in pancreatic cancer. Through this partnership with PanCAN, Genialis hopes to play a part in advancing therapeutic options for patients very much in need of effective new medicines.”
Genialis is now accepting applications for Genialis krasID’s early access program. Over 50 biopharma companies are currently developing more than 70 different KRAS-targeted drugs across over 12 disease indications. The total KRAS therapy market today is estimated at approximately $240 million, with a compound annual growth rate of 36% to reach $10 billion by 2032. Meanwhile, available diagnostics to support KRAS-targeted patient care are limited to mutation-based tests.
To learn more about Genialis biomarker programs or to schedule a meeting at ASCO, please visit https://www.genialis.com/rna-biomarkers/ or email biomarkers@genialis.com.
About Genialis
Genialis, the RNA biomarker company, is creating a world where healthcare delivers the best possible outcomes for patients, their families, and their communities. Genialis develops and validates clinically actionable biomarkers informed by the world’s most ethnographically diverse cancer data sets to better predict patient responses and guide treatment decisions for targeted inhibitors, immunotherapies, and other emerging therapeutic classes. Genialis is trusted by pharma and diagnostics partners, and together, we are transforming medicine through data. For more information, please visit www.genialis.com.
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