Bayer Starts Phase I Study With Novel Targeted Radionuclide Therapy 225Ac-PSMA-Trillium in Advanced Metastatic Prostate Cancer
May 15 2024 - 9:18AM
Business Wire
- 225Ac-PSMA-Trillium (BAY 3563254) is an investigational
next-generation PSMA-targeted alpha therapy with potential to treat
patients with advanced metastatic prostate cancer
- Prostate cancer is the second most commonly diagnosed cancer in
men1, with less than three years median survival among metastatic
patients, who have developed castration-resistance2
- Bayer remains committed to advancing medical innovations for
patients across all stages of prostate cancer
Bayer announced today initiation of dosing in a Phase I
first-in-human clinical study with 225Ac-PSMA-Trillium (BAY
3563254), a next-generation targeted alpha therapy. 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).
“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 (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.4-6
About Bayer
Bayer is a global enterprise with core competencies in the life
science fields of health care and nutrition. In line with its
mission, “Health for all, Hunger for none,” the company’s products
and services are designed to help people and the planet thrive by
supporting efforts to master the major challenges presented by a
growing and aging global population. Bayer is committed to driving
sustainable development and generating a positive impact with its
businesses. At the same time, the Group aims to increase its
earning power and create value through innovation and growth. The
Bayer brand stands for trust, reliability and quality throughout
the world. In fiscal 2023, the Group employed around 100,000 people
and had sales of 47.6 billion euros. R&D expenses before
special items amounted to 5.8 billion euros. For more information,
go to www.bayer.com.
References:
- GLOBOCAN. World fact sheet. 2022. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed March 2024.
- Amit D Raval et al. Prediction model for real-world survival in
men with castration-resistant prostate cancer and bone metastases
in the United States: A real-world database study. JCO Oncol Pract
19, 507-507 (2023).
- Zitzmann-Kolbe S, et al. Presented at: American Association of
Clinical Research Annual Meeting; April 5-10, 2024; San Diego, CA,
USA. Abstract ND09.
- Parker C, et al. JAMA Oncol. 2018;4(12):1765-1772.
- Tafreshi NK, et al. Molecules. 2019;24(23):4314.
- Hagemann UB, et al. Cancer Biother Radiopharm.
2020;35(7):497-510.
Find more information at www.pharma.bayer.com
Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer management. Various
known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results,
financial situation, development or performance of the company and
the estimates given here. These factors include those discussed in
Bayer’s public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
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Bayer Media: Julia Schulze, phone
+49 175 5866 432 Email: julia.schulze@bayer.com
Bayer U.S. Media: Carolyn Nagle,
phone +1 (201) 419-0337 Email: carolyn.nagle@bayer.com