The US Food and Drug Administration (FDA) has granted clearance to 280Bio’s investigational new drug (IND) application, thereby enabling initiation of a Phase I study of YL-17231 to treat patients with advanced cancer with RAS mutations.
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The study will be carried out at several US-based clinical cancer research centers including the MD Anderson Cancer Center in Houston, Texas.
280Bio intends to enroll patients for the dose escalation part of the study anticipated to begin in the fourth quarter of this year.
Yingli Pharma Research and Development head and general manager Dr Zusheng Xu said: “We are excited that YL-17231 has emerged from the company’s discovery platform, exemplifying the utility of our strong medicinal chemistry capabilities.
“YL-17231 has a broader activity than many current KRAS inhibitors and demonstrated strong inhibition of in vivo KRAS mutant xenograft tumor growth in our preclinical investigations.
“With its excellent pharmacologic properties, we are hopeful that YL-17231 will demonstrate to be safe and efficacious during continuous oral dosing in patients.”
The investigational drug, YL-17231 is a small molecule inhibitor of RAS signaling that is co-developed by 280Bio in association with Yingli Pharma and emerges from a strategic collaboration of 280Bio with The University of Texas MD Anderson Cancer Center, where further preclinical study is being undertaken of the drug.
The strategic collaboration with the MD Anderson Cancer Center is also advancing various cancer therapeutics into clinical development in the US/EU.
These include linpersilib (PI3Kδ inhibitor approved in China in 2022) being assessed in a Phase II trial for the treatment of T-cell lymphoma and YL-13027 (TGFβR1 inhibitor) currently in a Phase I dose escalation study.