Bayer and Kumquat initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

First patients enrolled in Phase I trial with KQB548, an investigational KRAS inhibitor designed to treat KRAS G12D-mutated tumors

Bayer and Kumquat Biosciences, a clinical-stage biotech company founded by pioneers of targeting the KRAS pathway, announced the initiation of a Phase I clinical trial with KQB548, an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer.

The first-in-human, dose-escalation study will evaluate the safety and preliminary efficacy of KQB548 as a monotherapy in patients with KRAS G12D mutated tumors. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent 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.

“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.”

KRAS G12D mutations are found most frequently in approximately 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers.2 These mutations are often recognized as important targets for cancer treatment, and their detection paves the way for the creation of tailored therapies.

Despite recent scientific advancements, there are currently no effective treatments available that provide durable therapeutic benefits for most patients with KRAS-G12D-mutated cancers. Introducing the KRAS G12D inhibitor into clinical trials aims to address the long-standing unmet need.

“We are excited to initiate the clinical trial of our KRAS G12D inhibitor KQB548, which holds the prospect of transforming the KRAS G12D treatments for the deadly malignancies such as pancreatic, lung and colorectal cancers,” said Dr. Nicolas Acquavella, Senior Vice President of Clinical Development and Corporate Alliance Management of Kumquat. “The speedy enrollment highlights our team’s execution capabilities and Kumquat’s long-standing commitment to delivering potentially life-changing medicines to cancer patients.”