BridgeBio Pharma, Inc. BBIO announced that it has entered into a non-exclusive clinical collaboration agreement with Amgen AMGN to evaluate the combination of its investigational SHP2 inhibitor BBP-398 with the latter’s KRAS G12C inhibitor Lumakras in patients with KRAS G12C-mutated advanced solid tumors.
Both BridgeBio and Amgen will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination in a phase I/II study. The study will first determine dose escalation for the combination followed by dose expansion and optimization.
Per the agreement terms, BridgeBio will be responsible for sponsoring the study while Amgen is responsible for the worldwide supply of Lumakras.
Per management estimates, KRAS mutations account for approximately 17% of malignant tumors. BridgeBio believes that the combination of an SHP2 inhibitor with a KRAS G12C inhibitor has the potential to prevent oncogenesis. BridgeBio also plans to enter into similar collaborations with other entities to explore such combinations.
Shares of BridgeBio have plunged 81.4% in the trailing 12 months compared with the industry’s 31.4% decline.
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BridgeBio is currently evaluating BBP-398 in a phase I study in solid tumor patients. BBIO is also evaluating BBP-398 as a monotherapy or in combination with other therapies to target patients having KRAS G12C mutations.
Lumakras is an FDA approved therapy approved since May 2021 for advanced non-small cell lung cancer (NSCLC). The launch of Lumakras in the United States is off to an excellent start, while its label expansion studies are progressing rapidly. Amgen generated $36 million from Lumakras’ sales in third-quarter 2021.
Another company that has a KRAS inhibitor in its pipeline is Mirati Therapeutics MRTX. Adagrasib, Mirati’s leading KRAS inhibitor candidate, is being studied both as a monotherapy and in combination in a phase I/II study (KRYSTAL) to treat patients with KRAS G12C-positive tumors.
Last October, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi SNY. The collaboration will evaluate the combination of Mirati’s KRASG12C inhibitor adagrasib with Sanofi’s investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.
Per the agreement terms, Mirati and Sanofi will jointly oversee and share costs of the above study. However, Sanofi will be responsible for sponsoring and operating the study.
BridgeBio carries a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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