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Boehringer Ingelheim Enters Clinical Collaboration with Amgen to Study BI 1701963, a SOS1::pan-KRAS Inhibitor, in Combination with LUMAKRAS¢â (sotoras

Combination of leading SOS1::pan-KRAS inhibitor with the first US FDA approved KRASG12C inhibitor has the potential to demonstrate additional therapeutic benefit for people living with KRAS G12C mutated cancers
Date: 2021-09-17

The new clinical partnership adds to Boehringer Ingelheim’s comprehensive program investigating combinations of its SOS1::pan-KRAS inhibitor, BI 1701963 with potentially synergistic approaches

INGELHEIM, GERMANY-- September 17, 2021 -- Boehringer Ingelheim today announced a clinical phase I collaboration with Amgen to evaluate the combination of BI 1701963, the first and most advanced SOS1::pan-KRAS inhibitor exhibiting activity against a broad spectrum of KRAS alleles, and LUMAKRAS™ (sotorasib), the first US Food and Drug Administration (FDA) approved KRASG12C inhibitor for adult patients with locally advanced or metastatic non-small cell lung cancer. The trial will investigate potential synergistic effects of this combination, possibly improving therapeutic outcomes beyond those of KRASG12C inhibitor therapy alone, specifically for people living with lung and colorectal cancers.

Preclinical data suggest that the combination of a KRASG12C inhibitor with a SOS1::pan-KRAS inhibitor may result in increased anti-tumor activity in KRAS G12C-driven cancers based on the complementary mechanisms of these targeted oncology agents.1 2 By shifting the equilibrium from active KRAS towards the inactive form, SOS1::pan-KRAS inhibitors have the potential to sensitize KRAS G12C-mutant tumors to covalent KRASG12C inhibitors that bind to inactive KRAS. In addition, SOS1 inhibitors block feedback reactivation which occurs upon pathway inhibition.

“We are excited to partner with Amgen, who have pioneered KRAS G12C inhibition, and to further expand our program to make a difference for people living with KRAS-driven cancers,” said Francesco Di Marco, Ph.D., Corporate Senior Vice President, Global Therapy Area Head Oncology at Boehringer Ingelheim. “Boehringer Ingelheim follows an ‘all-in’ research approach to taking cancer on, including the first and most advanced SOS1::pan-KRAS inhibitor which we investigate in several combinations and cancer types to realize even more opportunities to deliver potential therapeutic benefits to cancer patients.”

Under the terms of the non-exclusive collaboration, Amgen will be the sponsor of the trial and Boehringer Ingelheim and Amgen will jointly share the costs of and oversee clinical development for the combined therapy.



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