On June 29, 2021 Carmot Therapeutics, Inc. (Berkeley, CA), a clinical-stage biotechnology company applying its proprietary therapeutic platform, Chemotype Evolution (CE), to discover and develop disease-modifying therapies in metabolic disease and cancer, reported that in connection with the recent U.S. Food and Drug Administration (FDA) approval and commercial launch of Amgen’s LUMAKRAS (sotorasib), Carmot is eligible to receive royalty payments from future sales (Press release, Carmot, JUN 29, 2021, View Source [SID1234584452]).
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FDA recently approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Amgen and Carmot Therapeutics entered into a research collaboration and license agreement announced in 2014 with objectives that included identification of KRASG12C targeted therapeutics. Within this collaboration, Carmot and Amgen successfully applied Chemotype Evolution to identify novel binding sites and covalent inhibitors of KRASG12C. Amgen then built on those findings to develop LUMAKRAS. Under the terms of the agreement Carmot is entitled to research funding, milestone payments and a royalty on commercial sales of products emerging from the collaboration.
"The rapid development of LUMAKRAS illustrates the value of Chemotype Evolution and its ability to complement structure-based drug design and medicinal chemistry," commented Stig K. Hansen, PhD, Carmot’s co-founder and Chief Executive Officer. "Chemotype Evolution is a transformative technology that can accelerate the discovery of drugs for challenging targets. KRAS was deemed an undruggable target for decades, but Chemotype Evolution combined with published findings, enabled Carmot and Amgen to rapidly gain novel insights that aided Amgen in the discovery of AMG 510, now LUMAKRAS.
More broadly, we have greatly expanded the capabilities of Chemotype Evolution and used it to develop a portfolio of programs in metabolic disease and cancer. Just as Chemotype Evolution provided critical new insights into KRAS function, Carmot has used the technology to generate deep insights in other disease areas".