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

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.

"The advancement of KTX-2001 highlights both the urgent need for new therapies in advanced prostate cancer and the promise of a first-in-class NSD2-targeted approach. I am excited to have joined K36 Therapeutics at this pivotal moment as we advance KTX-2001, our second NSD2 inhibitor with potential across a broader range of solid tumors," said Dr. Cheng.

"Site activation is progressing ahead of schedule, with more than 75% of sites targeting activation by the end of the month and enrollment into subsequent cohorts underway. This early momentum reflects strong clinical interest in oral epigenetic modifier therapies for metastatic castration-resistant prostate cancer and underscores the urgent need for new treatment options for patients," said Jason Redman, M.D., Prostate Program Medical Director at K36 Therapeutics.

About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001)
STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation evaluating KTX-2001 as a monotherapy (Part A) and in combination with darolutamide (Part B).

Part A is designed to evaluate the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose(s) of KTX-2001 monotherapy. Part B will evaluate the safety and tolerability of KTX-2001 plus darolutamide to determine the recommended Phase 2 dose(s) for the combination. Secondary objectives include assessments of pharmacokinetics, pharmacodynamics, and preliminary clinical activity. K36 expects to enroll approximately 140 patients with mCRPC who have received prior androgen receptor inhibitors and prior chemotherapy.

KTX-2001 is a small molecule, selective inhibitor of nuclear receptor binding SET domain protein 2 (NSD2, also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). KTX-2001 inhibits NSD2-mediated methylation of histone H3 at lysine 36 (H3K36), disrupting aberrant NSD2-dependent oncogenic pathways.

About K36 Therapeutics, Inc.
Founded in February 2021, K36 Therapeutics is a privately held biotechnology company backed by Atlas Venture, F-Prime, Eight Roads Ventures, Nextech and Bristol Myers Squibb. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit www.k36tx.com and follow us on LinkedIn.

Contacts:

K36 Therapeutics
Soo Bang
[email protected]

Media
Sarah Sutton
[email protected]

SOURCE K36 Therapeutics