K36 Therapeutics Inc, a US-based privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, announced on Thursday that 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.

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).

K36 also announced a clinical trial collaboration agreement with German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) for supply of darolutamide for the combination with KTX-2001 in the trial.

Under the terms of the agreement, K36 will conduct and sponsor the trial and Bayer will supply darolutamide. K36 maintains development and commercial rights to KTX-2001. KTX-2001 is a highly potent and selective inhibitor of NSD2 that is being developed for the treatment of solid tumours, initially mCRPC, and compliments K36's first clinical candidate, KTX-1001, that is being developed for the treatment of relapsed and/or refractory multiple myeloma patients with genetic translocation.