KRAS Inhibitor Intermediate Cocrystallization for Scalable Synthesis

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Solution Overview

Problem

There is a need for efficient and scalable synthesis methods for intermediate compounds that inhibit KRAS G12C mutations, which are prevalent in various cancers and confer resistance to EGFR targeted therapies.

Innovation Solution

A method involving cocrystallization of a compound of Formula 4 with compounds of Formula (B) or (11), followed by reaction with phosphoryl chloride and (s)-1-boc-3-methylpiperazine, to produce compound 5M, which is then used to synthesize KRAS inhibitors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional synthesis methods are used to prepare intermediate compounds for KRAS G12C inhibitors, then the synthesis process is simpler, but the efficiency and scalability are insufficient

Engineering Contradiction:
Improvesynthesis efficiencyVSAvoidsynthesis process complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The synthesis process is divided into distinct modular stages: cocrystallization of compound 4 with chiral auxiliary (Formula B or 11) to obtain enantiomerically pure intermediate 5M, followed by reaction with phosphoryl chloride and (s)-1-boc-3-methylpiperazine. This segmentation allows each step to be optimized independently for both efficiency and scalability while maintaining overall process simplicity.

Inventive Principle:
Principle #1Segmentation

2Productivity

If conventional synthesis methods are used, then the process is easier to implement, but it lacks scalability for industrial production

Engineering Contradiction:
ImprovescalabilityVSAvoidmanufacturing ease
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The cocrystallization step with chiral auxiliary (Formula B or 11) is performed in advance to establish enantiomeric purity of intermediate 5M before subsequent reactions. This preliminary chiral resolution step enables scalable production of optically pure KRAS G12C inhibitor intermediates while simplifying downstream processing by eliminating the need for complex chiral separations later in the synthesis.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method enables the efficient production of KRAS inhibitors, potentially leading to effective treatments for cancers with KRAS mutations, such as pancreatic cancer, lung adenocarcinoma, and colorectal cancer, by providing high potency and selectivity for KRAS G12C.

Implementation Method 1

obtaining a compound of Formula 5M from a compound of Formula 4 through cocrystallization with a compound of Formula (B), or with a compound of Formula (11)

Methodology Applied
Scientific EffectCocrystallization: Crystallisation

Data Source

PatentEP4234546B1Improved synthesis of key intermediate of KRAS g12c inhibitor compound
Publication Date: 2026.04.15 AMGEN INC
  • EP4234546B1 patent drawingFigure 1~2-1
  • EP4234546B1 patent drawingFigure 2-2~2-3
  • EP4234546B1 patent drawingFigure 2-4~2-5

AI summary

The present invention relates to an improved, efficient, scalable process to prepare intermediate compounds, such as compound 5M, having the structure useful for the synthesis of compounds that target KRAS G12C mutations, such as