BridgeBio Announces Clinical Collaboration with Amgen on Cancer Combo

First clinical combination study of BBP-398 and LUMAKRAS set to evaluate safety and preliminary efficacy in solid tumors with the KRAS G12C mutation

 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a non-exclusive clinical collaboration with Amgen Inc. (Amgen) to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with LUMAKRAS® (sotorasib), a KRASG12C inhibitor, in patients with advanced solid tumors with the KRAS G12C mutation.

The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Amgen will provide a global supply of LUMAKRAS.

BBP-398 is a potent small-molecular inhibitor of SHP2 developed in collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. By combining SHP2 inhibition with KRASG12C inhibition in patients with the KRAS G12C mutation, there is potential that the investigational combination could prevent oncogenesis and overactive cellular proliferation.

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