Bayer bails on Vividion tumor drug as part of early-stage cancer clear-out

Bayer has cleared out four cancer candidates from its early-stage pipeline, including a STAT3 inhibitor acquired as part of its buyout of Vividion Therapeutics.

The Vividion asset in question, called VVD-130850 or BAY 3630914, is an oral small molecule inhibitor of a regulatory protein called STAT3 transcription factor. The therapy came under Bayer’s wing when the German pharma giant bought the California biotech for $1.5 billion in 2021.

That deal allowed Vividion to remain an independently operated subsidiary, and it was in this capacity that Vividion launched a phase 1 trial of VVD-130850 last year for the treatment of advanced solid and hematologic tumors.

Vividion’s CEO Aleksandra Rizo M.D., Ph.D., described the trial launch at the time as a “major inflection point” for the subsidiary, while Bayer’s leadership said clinical development of the STAT3 inhibitor program “takes us one step closer to a potentially meaningful new treatment for cancer patients.”

But in Bayer’s third-quarter earnings documents (PDF) this morning, the Big Pharma revealed that it has terminated the program.

Vividion and Bayer “made the strategic decision to discontinue the development” of VVD-130850 “based on the totality of the data, which includes safety, PK/PD and activity of the drug,” a Bayer spokesperson told Fierce Biotech this morning.

“Vividion remains committed to developing small molecule precision therapeutics that can improve outcomes for patients with devastating cancers and immune disorders,” the spokesperson added.

Another of the discontinued phase 1 programs revealed this morning focused on blocking an enzyme called diacylglycerol kinase (DGK) in T cells. The program consisted of a DGK-alpha inhibitor dubbed BAY 2862789 along with a DGKzeta Inhibitor called BAY 2965501. The assets originated from a research collaboration with the German Cancer Research Center.

Bayer had been assessing various doses of BAY 2965501 in an early-stage study for patients with a range of solid tumors as well as a separate study of BAY 2862789 in advanced solid tumors.

The hope was that inhibiting DGK could offer a potential new form of immunotherapy, but the company explained to Fierce this morning that it had discontinued this work as part of its routine evaluation of the portfolio “to focus our resources on the most promising options.”

The final cancer drug thrown on the scrap heap was an anti-human CCR8 antibody called BAY 3375968 or lanerkitug. Bayer had been assessing lanerkitug as a monotherapy and in combination with Merck's blockbuster oncology med Keytruda in a phase 1 study of patients with solid tumors.

When setting out the rationale for the clinical trial, Bayer had pointed to animal studies it said had shown the therapy “may add more anti-cancer effect to immunotherapy with PD-1/PD-L1 inhibitors when used in combination.”

The company told Fierce that lanerkitug had been another victim of its routine portfolio reevaluation.

“We are focused on the areas of greatest unmet need and highest potential where we can make a meaningful difference, including the areas of genitourinary, gastrointestinal and lung cancer,” the spokesperson said.