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Genialis, PanCAN Partner to Validate Biomarker for KRAS-Inhibitor Response, Benefit

NEW YORK – Bioinformatics firm Genialis said Friday that it has formed a partnership with the Pancreatic Cancer Action Network (PanCAN) to further validate a biomarker that is used in pancreatic cancer histology to predict the response to and clinical benefit of KRAS inhibitors.

Genialis KrasID is an RNA-based biomarker panel that is used with a machine learning-developed algorithm to analyze high-dimensional gene expression data and provide patient-specific information that can be used to help predict treatment outcomes. Anna Berkenblit, chief scientific and medical officer for PanCAN, said in a statement that the partnership is intended to accelerate the development of a new wave of KRAS-targeted therapies that could improve patient outcomes.

Genialis noted that the firm presented in April a poster at the American Association for Cancer Research 2024 Annual Meeting that indicated Genialis KrasID was used to predict preclinical drug response to a KRAS inhibitor with an accuracy of 0.94 area under the receiver operator curve (AUROC) and identify real-world patient response with an AUROC of 0.80. Using real-world time on treatment data as a proxy for progression-free survival, the firm said that it also found that patients who were classified by the panel as "KrasID-high" had a median time on treatment of 338 days compared to 158 days for patients who were classified as "KrasID-low."

“Nowhere is mutated KRAS more prevalent than in pancreatic cancer," Genialis CEO Rafael Rosengarten said in a statement. "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 said that the KRAS therapy market is estimated at about $240 million, and it is expected to total $10 billion by 2032 while the available tests to support KRAS-targeted therapies is limited to mutation-based tests. The firm said that the overactivation of KRAS is implicated in upward of 95 percent of pancreatic cancers.