Vividion Therapeutics starts Phase I clinical trial in advanced solid and hematologic tumors with oral STAT3 inhibitor

• VVD-130850 is an investigational oral small molecule inhibitor of STAT3 transcription factor developed for treatment of advanced solid and hematologic tumors as a single agent and in combination with checkpoint inhibitors
• Innovative clinical candidate that directly binds and modulates STAT3 function and expression of downstream target genes without affecting STAT3 protein level
• Another major milestone for Vividion’s leading-edge chemoproteomics drug discovery technology platform

Berlin, Germany and San Diego, CA, USA, February 6, 2024 – Vividion Therapeutics, Inc. (Vividion), announced today that it has initiated dosing of patients in a Phase I clinical trial evaluating VVD-130850, an investigational oral STAT3 inhibitor for the treatment of advanced solid and hematologic tumors. Vividion is a biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, utilizing innovative discovery technologies with the potential to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The start of the trial represents another major milestone for Vividion’s innovative chemoproteomics platform.

“The initiation and dosing of the first clinical trial with our STAT3 inhibitor program marks a major inflection point for Vividion as this is the second program from our platform that we have advanced into the clinic in just a few months. We are proud of the progress we have made in a relatively short amount of time with a pipeline consisting of previously undruggable protein targets for prominent oncology and immunology diseases,” said Aleksandra Rizo M.D., Ph.D., Chief Executive Officer of Vividion.

“We are leveraging Vividion’s innovative chemoproteomics drug discovery technology to develop new therapies that are addressing high profile cancer targets with the potential to stop or reverse the progression of disease,” said Christian Rommel, Ph.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “For millions of patients and their families, cancer continues to be a devastating disease, and new treatments are needed to address key drivers of tumor cell survival and growth. The start of the clinical development of Vividion’s STAT3 inhibitor program takes us one step closer to a potentially meaningful new treatment for cancer patients.”

VVD-130850 is an oral small molecule inhibitor of STAT3 binding to a novel allosteric pocket leading to direct inhibition of DNA binding and expression of STAT3 target genes in cancer cells. The Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of VVD-130850 in patients with advanced solid and hematologic tumors as a single-agent and in combination with immune checkpoint inhibition.

“We are excited to announce the initiation and dosing of this highly selective STAT3 inhibitor,” said Jenna Goldberg, M.D., Chief Medical Officer of Vividion. “What makes this clinical candidate really outstanding in our minds is that it binds to STAT3 to inhibit the expression of downstream target genes without affecting the STAT3 protein levels. We believe the STAT3 pathway holds promise to shift the treatment paradigm for cancer patients and look forward to advancing VVD-130850 through clinical development.”

The company is advancing multiple novel drug discovery programs toward the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery in the fields of oncology and immunology. Following the company’s acquisition by Bayer in August 2021, Vividion is operating at arm’s length in a best-of-both-worlds’ model, preserving its innovative, entrepreneurial culture while also leveraging Bayer’s deep expertise in small molecule drug development, global capabilities and financial strength.

About STAT3

Signal transducer and activator of transcription 3 (STAT3) is a key regulatory protein, which become hyperactivated in certain human cancers where it can promote tumor progression, metastasis, and decreased immune responses. Owing to its role in tumor formation, metastasis as well as drug resistance and immunosuppression, the STAT3 pathway is recognized as a promising therapeutic target in a wide range of cancers.

About Vividion

Vividion Therapeutics, Inc. a wholly owned and independently operated subsidiary of Bayer AG acquired in August 2021, 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.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Vividion Media Contact:

Laurie Sherman, phone +1 858.630.8246
Email: lauries@vividion.com

Bayer Media Contact:

Lisa Hennig, phone +49 172 8693420
Email: lisa.hennig@bayer.com

Find more information at https://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.