FDA Approves IND for AS1986NS, a New Approach in Prostate Cancer Research

Conceptual image for prostate cancer treatment: © Dr_Microbe - stock.adobe.com

• The investigational new drug (IND) application for AS1986NS, a novel prostate cancer diagnostic and treatment agent, has received FDA approval.
• With this IND approval, the drug is expected to enter phase 1/2 clinical trials.
• The anticipated start date is set for early 2025.

The FDA has approved the IND application for AS1986NS, an innovative drug designed to improve prostate cancer detection and treatment.1

This approval means the drug is now set to begin phase 1/2 clinical trials in early 2025.

Developed by Antelope Surgical, AS1986NS combines a fluorescent marker with lutetium-175, a radioactive isotope, to help identify cancerous tissue more precisely. The fluorescent marker will help surgeons distinguish cancerous from non-cancerous tissue during surgery, and the lutetium-175 radiolabel can provide detailed images of cancer sites through PET scanning.

AS1986NS is expected to help improve outcomes for patients with prostate cancer by enhancing imaging capabilities and allowing surgeons to be more precise during tumor removal. According to a press release, if the trials are successful, AS1986NS could eventually be applied to other types of cancers.

“We are thrilled to have reached this important milestone," said Amy Wu, MD, chief executive officer of Antelope Surgical, in the press release. "This approval brings us one step closer to offering a new hope for patients suffering from all stages of prostate cancer. Our goal is to automate surgery in the future to impact outcomes and improve efficiency."

The upcoming trials, which are still pending Institutional Review Board (IRB) approval and National Clinical Trial (NCT) registration, are planned to be led by Ashutosh Tewari, MD, from Mount Sinai in New York and Po-Hung Lin, MD, from Chang Gung Memorial Hospital in Taiwan. Their research will focus on assessing the safety and effectiveness of AS1986NS in patients with prostate cancer.

REFERENCE:

Antelope surgical solutions achieves commercial investigational new drug (IND) approval for PSMA-fluorescent novel drug AS1986NS. News release. Antelope Surgical Solutions, Inc. November 12, 2024. Accessed November 14, 2024. https://tinyurl.com/mpwf2wba