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

On February 6, 2024 Vividion Therapeutics, Inc. (Vividion), reported 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 (Press release, Vividion Therapeutics, FEB 6, 2024, View Source [SID1234639895]). 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.

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"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.