FDA Fast Tracks 225Ac-FL-020 in mCRPC

• A fast track designation has been granted to ²²⁵Ac-FL-020 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

• ²²⁵Ac-FL-020 works to target prostate-specific membrane antigen (PSMA).

• With this fast track designation, ²²⁵Ac-FL-020 shows potential to provide a novel therapeutic option for patients with mCRPC.

The FDA has granted a fast track designation to ²²⁵Ac-FL-02 for the treatment of patients with mCRPC.¹

"The FDA fast track designation for ²²⁵Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC", said Steffen Heeger, MD, MSc, chief medical officer of Full-Life, in a press release. "This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of ²²⁵Ac-FL-020 to patients."

²²⁵Ac-FL-020 is a novel, potential best-in-class, next-generation actinium-225 (²²⁵Ac)-based PSMA-targeting radionuclide drug conjugate that employs targeted alpha-radiotherapy designed to selectively attack cancer cells. This approach reduces damage to healthy tissues.

Preclinically, radiolabeled FL-020 demonstrated a promising in vivo biodistribution profile. High and sustained tumor uptake was observed, as well as fast systemic clearance. Further, ²²⁵Ac-FL-020 led to robust antitumor activity and had a favorable safety profile.

In May 2024, the company gained FDA clearance of its investigational new drug application to begin trials of ²²⁵Ac-FL-020 in the US and globally.² Now, a phase 1 trial plans to examine ²²⁵Ac-FL-020’s safety, tolerability, and antitumor activity when used as a treatment option for patients with mCRPC.

This phase 1 study plans to lay the foundation for further clinical development and aims to establish ²²⁵Ac-FL-020 as a valuable therapeutic option for patients with mCRPC.

REFERENCES:

1. Full-Life Technologies granted FDA fast track designation for 225Ac-FL-020 for the treatment of metastatic castration-resistant prostate cancer. News release. Full-Life Technologies. July 2, 2024. Accessed July 3, 2024. https://tinyurl.com/ycyjkpde

2. Full-Life Technologies announces clearance from FDA of IND application for 225Ac-FL-020 for the treatment of metastatic castration-resistant prostate cancer. News release. Full-Life Technologies. May 30, 2024. Accessed July 3, 2024. https://www.full-life.com/media/press-releases/24