ASN001 / Asana BioSci - LARVOL DELTA

Clinical activity and safety of ASN001, a selective CYP17 lyase inhibitor, administered without prednisone in men with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2017) - P1/2; "While the Phase 1 also allowed enrollment of pretreated patients, no prior enzalutamide (ENZA) or abiraterone (ABI) is permitted in Phase 2. Overall, ASN001 was safe and well tolerated without need for prednisone co-administration. Encouraging preliminary evidence of efficacy is based on the PSA decline observed in evaluable mCRPC pts not pretreated with ABI or ENZA and based on durable disease stabilization after progression on ABI and ENZA. Enrollment is ongoing at doses below 400mg QD in ABI/ENZA naïve mCRPC pts."

Clinical • Biosimilar • Oncology • Prostate Cancer • Urothelial Cancer

Clinical activity and safety of ASN001, a selective CYP17 lyase inhibitor, administered without prednisone in men with metastatic castration-resistant prostate cancer (mCRPC): A phase 1/2 clinical trial. (ASCO 2017) - P1/2; "While Ph 1 also allowed enrollment of pretreated patients, no prior enzalutamide (ENZA) or abiraterone (ABI) is permitted in Ph 2. Overall, ASN001 was safe and well tolerated. Prednisone co-administration was not needed. Encouraging preliminary evidence of efficacy is reflected by PSA declines in evaluable mCRPC pts not pretreated with ABI or ENZA and by durable disease stabilization in refractory disease."

Clinical • P1/2 data • Biosimilar • Prostate Cancer

Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=116; Recruiting; Sponsor: Asana BioSciences; N=90 ➔ 116

Enrollment change • Biosimilar • Oncology • Prostate Cancer