Bayer and Vividion Therapeutics to highlight advancing oncology portfolio at AACR 2024 Annual Meeting

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April 3, 2024

Press release

  • In New Drugs on the Horizon session, Bayer will present preclinical and clinical imaging data on actinium-225 (225Ac)-PSMA-Trillium, a targeted radionuclide therapy being developed for the treatment of metastatic castration resistant prostate cancer
  • Preclinical data to be presented on synergistic anti-cancer effects of radium-223 dichloride in combination with androgen receptor inhibitor darolutamide in different prostate cancer models
  • Vividion Therapeutics will present preclinical data on the development and characterization of covalent inhibitors of the RAS-PIK3CA interaction

Abstracts: ND09; 688 / 1; 6033 / 15; 6501 / 18

Berlin, Germany, and San Diego, CA, USA, April 3, 2023 – Bayer and Vividion Therapeutics, Inc. (Vividion) will present the latest research on their advancing oncology portfolio at the upcoming American Association for Cancer Research (AACR) 2024 Annual Meeting, taking place from April 5-10, 2024, in San Diego, California. Bayer will present preclinical data as well as clinical imaging results from its evolving portfolio of targeted alpha therapies, an emerging class of targeted radionuclide therapy and a focus of Bayer’s precision drug development strategy in oncology. Vividion, a wholly owned and independently operating subsidiary of Bayer AG, will provide, for the first time, insights into the development and characterization of its novel preclinical covalent inhibitors of the RAS-PIK3CA interaction as a new therapeutic means of blocking the oncogenic PI3K signaling pathway.

During the New Drugs on the Horizon session Bayer will introduce actinium-225 (225Ac)-PSMA-Trillium, a next-generation targeted alpha therapy targeting prostate specific membrane antigen (PSMA). The novel investigational candidate comprises a customized albumin-binding moiety designed to improve therapeutic efficacy and reduce side effects in normal organs, such as salivary glands. The data presented will include preclinical in vitroand in vivocharacterization, along with the results of a Phase 0 imaging study in patients with Indium-111 (111In) -PSMA-Trillium, a surrogate to evaluate the biodistribution in normal organs and tumor targeting of the therapeutic agent.

Bayer is progressing novel research around its prostate cancer treatment darolutamide (Nubeqa™). Another abstract will highlight the synergistic anti-cancer effects of targeted alpha therapy radium-223 dichloride (Xofigo™) in combination with darolutamide in preclinical prostate cancer models. Darolutamide, which is jointly developed by Bayer and Orion Corporation, is an oral androgen receptor inhibitor indicated in combination with androgen deprivation therapy (ADT) for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, and for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with ADT and docetaxel.

Vividion will present its latest research on the development and characterization of novel preclinical covalent inhibitors of the RAS-PIK3CA interaction, preventing RAS mediated activation of PIK3CA. Traditional strategies of targeting the PI3K pathway do not discriminate between RAS dependent and RAS independent signaling, which leads to dose-limiting toxicities. The preclinical data presented suggest that these toxicities can be potentially mitigated with the Vividion molecules and support future clinical investigation of these molecules, particularly in combination with therapies targeting the MAPK pathway or directly targeting mutant KRAS, where they may provide a tolerable and efficacious means of blocking the PI3K pathway.

Information on the registration as well as the virtual scientific program can be found here. Key presentations on Bayer and Vividion research to be presented at AACR 2024 are listed below.

Selected Bayer presentations:

Oral:

225Ac-PSMA-Trillium (BAY 3563254): Preclinical evaluation and clinical imaging study of a novel 225Ac-labeled PSMA-targeting small molecule triad for the treatment of mCRPC

  • Abstract ND09, Session: DDT03 – New Drugs on the Horizon: Part 3
    • Monday, April 8, 10:20 AM – 10:35 AM (PT), Ballroom 20 CD – Upper Level, Convention Center

Poster:

Preclinical evaluation of an actinium-225 labeled PSMA-targeting small molecule (225Ac-PSMA-Trillium (BAY 3563254) for the treatment of metastatic castration resistant prostate cancer (mCRPC)

  • Abstract #6033 / 15, Session: PO.ET08.02 – Radiation, Theranostics, Radiotheranostics, Normal Tissue, and Cellular Stress
  • Tuesday, April 9, 1:30 PM – 5:00 PM (PT), Section 29, Convention Center

Radium-223 in combination with darolutamide exhibits synergistic antitumor efficacy in LNCaP prostate cancer models

  • Abstract #688 / 1, Session: PO.ET08.01 – Radiotherapeutic Combinations, Modifiers, Protectors, Sensitizers, and Molecular Targets
    • Sunday, April 7, 1:30 PM – 5:00 PM (PT), Section 28, Convention Center

Vividion Therapeutics presentation:

Development and characterization of covalent inhibitors of the RAS-PIK3CA interaction

  • Abstract #6501 / 18, Session: PO.CL08.02 – Targeting Kinase and ERK Pathways
    • Tuesday, April 9, 1:30 PM – 5:00 PM (PT), Section 46, Convention Center

About Targeted Alpha Therapy

Targeted alpha therapy (TAT) is an emerging class of radionuclide therapy that can be used against a variety of tumors. It delivers 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. Compared to beta particles, alpha particles deposit highly ionizing radiation over a short range. This localized delivery of the radioactive payload induces difficult to repair double-strand DNA breaks; 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.1-3 Xofigo™ (radium-223 dichloride, radium-223) is the first approved TAT proven to extend the lives of men with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases and the first approved targeted radionuclide therapy for prostate cancer.

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.

About Vividion Therapeutics

Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The company’s platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high value, traditionally undruggable targets in oncology and immunology. For more information, please visit www.vividion.com.

References:

  1. Parker C, et al. JAMA Oncol. 2018;4(12):1765-1772.
  2. Tafreshi NK, et al. Molecules. 2019;24(23):4314.
  3. Hagemann UB, et al. Cancer Biother Radiopharm. 2020;35(7):497-510

Bayer Media Contact:

Julia Schulze, phone +49 175 5866 432

Email: julia.schulze@bayer.com

Vividion Media Contact:

Laurie Sherman, phone +1 858.630.8246

Email: media@vividion.com

Find more information at www.pharma.bayer.com

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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 conformthem to future events or developments.