BridgeBio (BBIO), Amgen Partner in Advanced Solid Tumors Study

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Bridge Bio Pharma, Inc. BBIO announces that it has entered into a non-exclusive clinical collaboration agreement with Amgen AMGN to evaluate the combination of the experimental SHP2 inhibitor BBP-398 with the last KRAS G12C inhibitor Lumakras in patients with advanced KRAS G12C advanced solid tumors.

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BridgeBio and Amgen will evaluate the initial safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the combination in a phase I/II study. The study will first determine the dosage increase for the mixture followed by dosage expansion and optimization.

Under the terms of the agreement, BridgeBio will be responsible for sponsoring the study while Amgen will be responsible for supplying Lumakras worldwide.

According to management estimates, KRAS mutations account for approximately 17% of malignancies. BridgeBio believes that the combination of an SHP2 inhibitor and a KRAS G12C inhibitor has the potential to prevent tumorigenesis. BridgeBio also plans to enter into similar collaborations with other entities to explore such groups.

BridgeBio shares are down 81.4% in the subsequent 12 months compared to the industry’s 31.4% decline.

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BridgeBio is currently evaluating BBP-398 in a phase I study in patients with solid tumors. BBIO is also evaluating BBP-398 as monotherapy or in combination with other therapies to target patients with KRAS G12C mutations.

Lumacras is an FDA-approved treatment that has been approved since May 2021 for advanced non-small cell lung cancer (NSCLC). The launch of Lumacras in the US is off to an excellent start, while studies of its own label expansion are progressing rapidly. Amgen generated $36 million in sales of Lumacras in the third quarter of 2021.

Another company has a KRAS inhibitor in its pipeline Mirati Healing MRTX. Adagrasib, Mirati’s leading KRAS inhibitor candidate, is being studied as monotherapy and as a combination therapy in a Phase I/II (KRYSTAL) study for the treatment of patients with KRAS G12C-positive tumors.

Last October, Merati entered into a non-exclusive clinical cooperation agreement with Sanofi SNY. The collaboration will evaluate the combination of the KRASG12C inhibitor adagrasib from Mirati with an investigational SHP2 inhibitor from Sanofi SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and extension study in previously treated NSCLC patients with KRAS G12C mutations.

In accordance with the terms of the agreement, Meratti and Sanofi will jointly supervise and share the above-mentioned tuition costs. However, Sanofi will be responsible for the care and operation of the study.

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BridgeBio holds a Zacks rating of #3 (Hold) at present. you can see The full list of Zacks #1 stocks (strong buy) today is here.

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