India Pharma Outlook Team | Friday, 10 October 2025
Bayer and Kumquat Biosciences, a clinical-stage biotech company established by pioneers in targeting the KRAS pathway, have announced the start of a Phase I clinical trial for KQB548, an investigational inhibitor aimed at treating KRAS G12D-mutated tumors, including pancreatic, colorectal, and lung cancers.
This first-in-human, dose-escalation study will assess the safety and early efficacy of KQB548 as a standalone therapy in patients with KRAS G12D mutations. KRAS mutations are present in nearly 25 percent of human cancers; however, the most common and oncogenic KRAS variant (G12D) still lacks effective treatment options.
“Initiating clinical development of investigational KRAS G12D inhibitor KQB548 (BAY 3771249) marks an important milestone in our commitment to develop new medicines targeting highly relevant signaling pathways that promote tumor growth and survival,” said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division.
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“Targeting KRAS has been considered quite challenging. We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can unlock the potential of precision oncology and improve the lives of people living with cancer.”
About 37% of pancreatic ductal adenocarcinoma (PDAC), 13% of colorectal cancer, and 4% of non-small cell lung tumors include KRAS G12D mutations.2 The identification of these mutations opens the door to the development of customized medicines, which are frequently acknowledged as crucial targets for cancer treatment.
