eClinical Technology and Industry News

K36 Therapeutics Completes Dosing of First Cohort in Phase 1 Clinical Trial of KTX-2001 in Prostate Cancer, Announces New CMO

KTX-2001 being evaluated both as a monotherapy and in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

Shinta Cheng, M.D., Ph.D., joins company as Chief Medical Officer

Excerpt from the Press Release:

CAMBRIDGE, Mass., Feb. 5, 2026 /PRNewswire/ — K36 Therapeutics, Inc. (“K36”), a privately held clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, today announced completion of dosing in the first patient cohort of its Phase 1 clinical trial evaluating KTX-2001, a first-in-class, orally administered, selective NSD2 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). This study marks the company’s second NSD2 inhibitor to enter the clinic.

The Phase 1 clinical trial, STRIKE-001 (NCT07103018), is a multi-center, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B).

“KTX-2001 is a first-in-class NSD2 inhibitor targeting a long-recognized epigenetic driver of prostate cancer biology,” said Terry Connolly, Ph.D., President and Chief Executive Officer, K36 Therapeutics. “Despite recent therapeutic advances, many patients ultimately exhaust effective options. This trial introduces a novel epigenetic mechanism with the potential to open an entirely new treatment paradigm for men with advanced disease.”

In parallel with advancing its lead clinical programs, K36 recently appointed Shinta Cheng, M.D., Ph.D., as Chief Medical Officer. Dr. Cheng brings more than 20 years of global oncology and hematology drug development experience, including leadership roles at SpringWorks Therapeutics, Johnson & Johnson, and Bristol Myers Squibb, with deep expertise in prostate cancer, including leading the development of apalutamide and niraparib.

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