Clinical-stage biotechnology company K36 Therapeutics Inc on Thursday 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, is a multi-centre, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B).
Terry Connolly, PhD, K36 Therapeutics' president and CEO, said: "KTX-2001 is a first-in-class NSD2 inhibitor targeting a long-recognised epigenetic driver of prostate cancer biology. 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."
Akeso agrees clinical trial collaboration with INOVIO
Airiver Medical's Airiver Pulmonary DCB receives US FDA Breakthrough Device Designation
Frontage Laboratories acquires Teddy Clinical Research Laboratory in China
Allergy Therapeutics reports positive biomarker data from PROTECT trial
HUTCHMED doses first patient in global trial of ATTC candidate HMPL-A580
Ensorcell adds new senior leadership team members
Sino Biological launches 2026-2027 Northern Hemisphere influenza vaccine strain antigens
Sanaregen receives FDA clearance for retinal degeneration clinical trial
Lynk Pharmaceuticals reveals positive topline results from zemprocitinib Phase III clinical trial
ReviR Therapeutics doses first participant in First-in-Human Phase 1 clinical trial of RTX-117
Ono Pharmaceutical expands multi-target research collaboration with Congruence Therapeutics
United Therapeutics' ralinepag reduces risk of clinical worsening in pivotal PAH study
Genentech's fenebrutinib meets primary endpoint in pivotal Phase III study for multiple sclerosis
ValiRx establishes animal health subsidiary to target veterinary oncology market
FDA accepts rusfertide NDA and grants priority review for polycythemia vera