Bayer Begins Phase I Trial for New 225Ac-PSMA-Trillium Therapy in Advanced Prostate Cancer

Bayer has announced the commencement of dosing in a Phase I clinical trial for 225Ac-PSMA-Trillium (BAY 3563254), an investigational next-generation PSMA-targeted alpha therapy. This new treatment, marked with actinium-225, incorporates a novel PSMA-targeting small molecule combined with a customized albumin-binding component. The aim is to enhance therapy effectiveness while minimizing adverse effects on normal organs, such as salivary glands. The dose-escalation study (NCT06217822) will assess the safety, tolerability, and efficacy of 225Ac-PSMA-Trillium in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is the second most commonly diagnosed cancer in men, with patients suffering from metastatic forms typically having a median survival rate of less than three years. Bayer is dedicated to developing innovative medical solutions for patients at all stages of prostate cancer. Fred Saad, MD, FRCS, Professor and Chairman of Surgery at the University of Montreal, highlighted the ongoing need for novel precision therapies to improve outcomes for metastatic castration-resistant prostate cancer patients. He noted that 225Ac-PSMA-Trillium could address this requirement by offering a new treatment approach.

Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer, emphasized that targeted radionuclide therapy is a crucial part of Bayer's precision oncology strategy. He expressed excitement about the initiation of Phase I and the first dosing of a patient with 225Ac-PSMA-Trillium, highlighting its unique design and potential benefits for patients with metastatic prostate cancer. Bayer is committed to advancing this program through clinical development.

Despite significant advances over the past decade, metastatic castration-resistant prostate cancer remains a lethal disease with a median survival of approximately 31 months. Bayer's focus on prostate cancer underscores its commitment to improving medical options for these patients.

In April, Bayer introduced 225Ac-PSMA-Trillium at the AACR Annual Meeting during the New Drugs on the Horizon session. Results from preclinical in vitro and in vivo studies, along with a Phase 0 clinical imaging and dosimetry study conducted on prostate cancer participants, were presented.

Targeted alpha therapy, such as 225Ac-PSMA-Trillium, represents an emerging class of radionuclide therapies aimed at various tumors. This therapy delivers alpha particle radiation directly to tumors within the body, either through its bone-seeking properties or by combining alpha radionuclides with specific targeting agents. The localized delivery of radioactive material causes significant DNA damage in tumor cells, leading to cell cycle arrest or cell death, while minimizing harm to adjacent healthy tissues.

Bayer is a global enterprise that focuses on health care and nutrition, driven by the mission "Health for all, Hunger for none." The company's products and services aim to help people and the planet thrive, addressing challenges posed by a growing and aging global population. Bayer is committed to sustainable development and aims to positively impact the world through its innovations and growth. In fiscal 2023, Bayer employed approximately 100,000 people and reported sales of 47.6 billion euros, with R&D expenses before special items amounting to 5.8 billion euros.