Takeda inks $1.2B deal for Innovent cancer drug, boosting pipeline and revenue growth prospects
Takeda Pharmaceuticals is beefing up its pipeline in a big way, committing $1.2 billion to buy the rights to two late-stage cancer drugs from Innovent Biologics and gaining exclusive options to license early-stage programs, all of which have potential applications in treating a range of solid tumors.
The deal is important because Takeda, like other big drug companies, needs new products to make up for declining revenue as it faces a patent cliff. The patent on Takeda's best-selling ulcerative colitis and Crohn's disease drug Entyvio has expired in Europe and will expire in 2026 in the United States and Japan. While it's unclear when biosimilars of antibody drug Entyvio will hit the market, the patent expiration opens the door to competition that will eat into revenue from the blockbuster product.
Takeda is trying to cushion the slide from the patent cliff with drugs discovered and developed internally, as well as assets from commercial deals. Announcing the licensing deal with Innovent on Wednesday, Teresa Bitettie, president of Takeda's global oncology business unit, said the two drugs from the Chinese biotech company “have the potential to transform our oncology portfolio and significantly enhance Takeda's growth potential beyond 2030.”
Takeda's first drug from Innovent is IBI363. This bispecific antibody fusion protein is designed to block the checkpoint protein PD-1 and activate the IL-2 pathway, stimulating the activity of tumor-specific T cells expressing both targets. The companies say this approach is designed to more efficiently activate and expand T cell subsets without triggering the toxic effects of activated peripheral T cells.
Global Phase 2 trials of IBI363 are ongoing for the treatment of non-small cell lung cancer and microsatellite stable colorectal cancer, which accounts for the majority of colorectal cancer cases. The global Phase 3 study in second-line squamous non-small cell lung cancer is expected to begin in the coming months. The two companies will co-develop the drug globally, with costs and potential profits/losses borne 60% by Takeda and 40% by Innovent. The agreement also makes Takeda the lead for co-commercialization of IBI363 in the United States and gives the Japanese pharmaceutical giant exclusive rights to commercialize the drug outside the United States and Greater China.
The second drug is IBI343, an antibody-drug conjugate (ADC) that targets claudin 18.2, a protein highly expressed in gastric and pancreatic cancer cells. This is a proven goal. Last year, the FDA approved Astellas Pharma's Vyloy for the treatment of gastric or gastroesophageal junction adenocarcinoma, making the antibody the first approved drug targeting Claudin 18.2. AstraZeneca is developing claudin 18.2 and sonesitatug vedotin (formerly AZD0901); ongoing Phase 3 testing is evaluating this ADC as a second-line treatment for advanced or metastatic gastric cancer that expresses the target protein. Phase 3 trials of Innovent Biologics' ADC are ongoing in Japan and China, recruiting previously treated gastric cancer patients. Takeda plans to further clinical development and expand into first-line gastric and pancreatic cancers.
Takeda's agreement with Innovent gives the pharmaceutical giant the option to license IBI3001. The drug is a bispecific ADC designed to target the EGFR and B7H3 proteins. Phase 1 trials of IBI3001 are ongoing in the United States, China and Australia, enrolling patients with locally advanced or metastatic solid tumors. Innovent is responsible for clinical development of the ADC until Takeda exercises its licensing option for the asset. Exercising the option will put Takeda in charge of developing, manufacturing and commercializing IBI3001 globally outside of Greater China.
Takeda said it plans to manufacture drugs covered by the Innovent Biologics agreement in the United States, continuing a trend of major pharmaceutical companies expanding U.S. production capacity to avoid President Trump's threat of drug tariffs. In the deal announcement, Takeda R&D president Andy Plump said the Innovent program strengthens Takeda's late-stage oncology pipeline.
“With our extensive experience in oncology and the modalities leveraged by IBI363 and IBI343, we are uniquely positioned to work with Innovent to accelerate and expand the potential of these investigational drugs across a range of solid tumors,” he said. “We are encouraged by the clinical results demonstrated by these investigational medicines and look forward to collaborating with Innovent to deliver these potentially best-in-class medicines to patients with long-standing unmet needs across multiple cancers.”
Takeda's $1.2 billion upfront payment to Innovent includes a $100 million equity investment in the biotech company. Innovent is eligible to receive up to $10.2 billion in milestone payments related to progress on licensed assets. Innovent will also receive royalties from sales of each molecule commercialized outside Greater China, except for IBI363 in the United States, where the companies will share profits and losses. If Takeda exercises its option on IBI3001, Innovent will receive an option exercise fee as well as additional potential milestones and royalties. Details of those potential payments were not disclosed.
Photo: Kiyoshi Ota/Bloomberg via Getty Images
