On May 15, 2024 Bayer reported initiation of dosing in a Phase I first-in-human clinical study with 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (Press release, Bayer, MAY 15, 2024, View Source [SID1234643373]). The investigational candidate, labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen) -targeting small molecule with a customized albumin-binding moiety, is designed to potentially improve therapeutic efficacy and reduce side effects in normal organs such as salivary glands. The dose-escalation study (NCT06217822) will evaluate the safety, tolerability and efficacy of 225Ac-PSMA-Trillium in patients with advanced metastatic castration resistant prostate cancer (mCRPC).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Despite recent advances in the treatment landscape for prostate cancer, there is still a high unmet need for novel precision therapy options to improve outcomes for patients with metastatic castration-resistant prostate cancer," said Fred Saad, MD, FRCS, Professor and Chairman of Surgery at University of Montreal and Director of Genitourinary Oncology at University of Montreal Hospital Center (CHUM), Canada."225Ac-PSMA-Trillium is a novel approach, which could provide a new treatment to address this unmet need in mCRPC."
"Targeted radionuclide therapy is a strategic pillar of precision oncology at Bayer, holding the promise to shift the treatment paradigm for patients, including those whose disease has developed resistance to other treatments," said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer. "We are excited to announce initiation of the phase I and dosing of the first patient with 225Ac-PSMA-Trillium. With its unique design, we believe it could offer a meaningful benefit for patients with metastatic prostate cancer, and we look forward to advancing the program through clinical development."
Prostate cancer is the second most commonly diagnosed cancer in men1 and a key area of focus at Bayer. Despite significant advances in the last decade, mCRPC remains a deadly disease with a median survival of about 31 months.2 Bayer remains committed to advancing medical innovations for patients across all stages of prostate cancer.
In April, Bayer introduced 225Ac-PSMA-Trillium during the New Drugs on the Horizon session at the AACR (Free AACR Whitepaper) (American Association of Cancer Research) Annual Meeting.3 Along with preclinical in vitro and in vivo characterization, the results were presented for a Phase 0 clinical imaging and dosimetry study conducted in participants with prostate cancer.
About Targeted Alpha Therapy
Targeted alpha therapy is an emerging class of radionuclide therapy that can be used against a variety of tumors. It is designed to deliver alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties. This localized delivery of the radioactive payload induces difficult to repair double-strand DNA breaks in tumor cells; damage that can cause cell cycle arrest or cell death. At the same time, because the energy does not travel very far, there is a potential for reduced damage to nearby normal tissues.