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K36 Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for KTX-2001 in Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Announces Clinical Trial Collaboration with Bayer for Supply of Darolutamide
K36 Therapeutics, Inc. ("K36"), a privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, today announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application for KTX-2001, a selective, oral inhibitor of NSD2 (nuclear receptor-binding SET domain protein 2), a histone methyltransferase and oncogene that activates gene expression in some cancers.
About this update from Bayer Ag
[{"type":"text","content":"KTX-2001 is Company's second selective inhibitor of NSD2 to enter the clinic","length":80,"tagName":"p"},{"type":"text","content":"K36 to initiate first-in-human Phase 1 clinical study evaluating KTX-2001 as monotherapy and in combination with darolutamide in mCRPC patients ","length":143,"tagName":"p"},{"type":"text","content":"K36 is working with The Prostate Cancer Clinical Trials Consortium (PCCTC) as academic CRO partner","length":98,"tagName":"p"},{"type":"text","content":"CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, today announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application for KTX-2001, a selective, oral inhibitor of NSD2 (nuclear receptor-binding SET domain protein 2), a histone methyltransferase and oncogene that activates gene expression in some cancers.","length":526,"tagName":"p"},{"type":"image","alt":"K36 logo (PRNewsfoto/K36 Therapeutics)","displaySize":"","headline":null,"caption":"K36 logo (PRNewsfoto/K36 Therapeutics)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":275,"url":"https://media.zenfs.com/en/prnewswire.com/ce5b97762406c844fccf90d734f721ee"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Yj0wqBkzhDbvr1UYC32xCA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ4NTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/ce5b97762406c844fccf90d734f721ee","width":400,"height":275}},"href":"https://mma.prnewswire.com/media/2050745/K36_Therapeutics_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"With this clearance, KTX-2001 becomes the second NSD2 inhibitor from K36 to advance into clinical development. This Phase 1 program will evaluate KTX-2001 both as a monotherapy and in combination with Bayer's androgen receptor inhibitor, darolutamide, for metastatic castration-resistant prostate cancer (mCRPC) NCT07103018.","length":328,"tagName":"p"},{"type":"text","content":""We are proud to announce the FDA cleared the IND for our second clinical program, KTX-2001, on July 3rd. This achievement demonstrates our team's efficiency and focus on advancing KTX-2001 and positively impacting the lives of patients wi...