Ramesh Narayanan, Interim Associate Dean of Research at The University of Tennessee Health Science Center, shared on LinkedIn:
“Proud to see the first-in-human clinical data for ONCT-534 (RAM-004) published in Investigational New Drugs. ONCT-534, a molecular glue degrader discovered in our laboratory, currently licensed to Ionib Inc., and has received FDA Fast Track designation.
Phase I results in advanced metastatic castration resistant prostate cancer (mCRPC) patients demonstrated a favorable safety profile, significant decrease of AR protein (average 41%; 7/10 patients) and AR splice variants gene expression (AR-V7/AR-V9), and clear evidence of on-target biological activity, validating our preclinical findings.
Most importantly, these findings provide the clinical proof that targeted degradation of AR is achievable in patients. While clinical responses were limited before the study closed early due to funding reasons at Oncternal therapeutics (previous licensee), the biomarker data establishes an important proof-of-concept for next-generation AR degraders and biomarker-guided trials.
Congratulations to Shuang Zhao, Joshua Lang, Matthew Chrostek, Evan Yu, and their colleagues for advancing this work to the clinic.”
This also can be interesting:
Chemotherapy in Prostate Cancer: Current Evidence and Clinical Applications
