On June 17, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial for the treatment of high-grade B-cell lymphoma that is resistant or refractory to first-line and second-line treatments with PC-002, an inhibitor that targets MYC mutations (Press release, Cothera Bioscience, JUN 17, 2021, View Source [SID1234618852]).

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PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancer involving MYC dysregulation.

Dr. Alex Wu, Co-founder and CEO of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials is an important milestone for Cothera. I believe this is a good start, and the company will continue its effort to launch late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."