With Innovent Biologics garnering buzz in the dealmaking space, Takeda is adding more credence to its own multi-billion-biobucks collab with the Chinese company that granted access to a first-in-class bispecific with “tremendous potential.”
That’s according to Takeda’s Phuong Khanh Morrow, M.D., who heads up the Japanese pharma’s oncology therapeutic area unit and spoke with Fierce in a joint interview on the sidelines of the American Society of Clinical Oncology annual meeting in Chicago. At the conference, Takeda and Innovent offered a glimpse of the potential benefits of their bispecific candidate, IBI363, in advanced immunotherapy-resistant non-small cell lung cancer (NSCLC).
IBI363 is a PD-1/IL-2 alpha-biased bispecific designed to unleash antitumor immune responses by blocking PD-1 signaling while also acting on IL-2 to activate and expand tumor-specific T cells. Multiple companies have bet on IL-2, most notably Bristol Myers Squibb through its huge, ill-fated Nektar Therapeutics deal, without realizing the potential of the cytokine to make cancer immunotherapies more broadly effective.
Innovent arrived at ASCO with long-term follow-up data from a phase 1 proof-of-concept study for IBI363, also now known as TAK-928, which enrolled 136 patients in China who received the med as a monotherapy once every three weeks. The 67 patients who had squamous NSCLC with no known EGFR mutations were divided between different doses, with the 3 mg dose group achieving a median progression-free survival (PFS) of 10.1 months and a median overall survival (OS) of 18.2 months.
Over 24 months, the OS rate among these patients came out at 47.8%, Innovent and Takeda reported.
Of the 58 patients with EGFR wild-type NSCLC with an adenocarcinoma history (adenoNSCLC), those in the 3 mg dose group saw PFS of 4.2 months and OS of 15.2 months, along with a similar 24-month OS rate of 42.7%. During the study, smoking history emerged as a potential influential factor for efficacy in immuno-resistant adenoNSCLC, with better survival benefits observed in those with a smoking history, according to Innovent.
To put it another way, more than 40% of patients with either squamous or adenoNSCLC in the 3 mg cohort lived beyond 24 months, as Zhejiang University’s Jianya Zhou, M.D., Ph.D., pointed out in a June 1 press release. Zhou also highlighted the therapy's potential to generate a “durable immunotherapy tail effect and deliver long-term survival benefits for patients.”
The IL-2 arm of IBI363 is designed to specifically target the tumor-specific T-cells within the tumor microenvironment, allowing “really strong, robust and durable cancer cell kill” while minimizing the risk of systemic toxicity or adverse events, Takeda's Morrow explained. Meanwhile, the PD-1 arm reduces the likelihood of T-cell exhaustion and helps to further hone the bispecific cells to tumor-specific T-cells, she said.
“It’s unique, it’s differentiated—there’s not another one like it,” Teresa Bitetti, president of Takeda’s global oncology business unit, added in the joint interview with Fierce, citing the “brilliant engineering on the part of Innovent.”
“It’s not like you're taking a bispecific, and there’s just sort of additive activity—these are synergistic,” Bitetti explained.
Takeda also presented a poster at ASCO setting out IBI363's potential as a first-line option alongside chemotherapy in patients with advanced NSCLC. The standard treatment course is an immunotherapy and a platinum-based doublet chemotherapy, but five-year survival rates are low even with that regimen.
Eighty patients in the dose-optimization study were dosed, with the regimen ultimately proving “well tolerated” with “encouraging efficacy” in advanced disease, researchers noted.
Meanwhile, a global phase 3 study, dubbed MarsLight-11, is currently enrolling patients with unresectable, locally advanced or metastatic squamous NSCLC who have progressed on or after platinum-based chemotherapy and anti-PD-1/PD-L1 treatments. That could be followed by a separate late-stage study in IO-resistant non-squamous NSCLC, which is “pending regulatory communications,” Innovent said in its release.
“Stay tuned on this molecule,” Bitetti told Fierce. “I think it's very unique, and I think it holds enormous promise that's different than a lot of the other agents that we're seeing out there right now.”
She pointed to evidence so far on the duration of effect of IBI363 as well as the flexibility to use it as a monotherapy or in a combo treatment, “which a lot of other bispecifics don’t” have.
It’s this potential that made Takeda eager to buy a stake in Innovent’s oncology pipeline, shelling out $1.2 billion upfront back in October 2025 as well as agreeing to $10.2 billion in potential milestone payments. The deal stipulates co-global development with a 60/40 cost split between Takeda and Innovent, respectively, for IBI363 and co-commercialization under the same profit split in the U.S. Takeda holds exclusive commercialization rights outside of the U.S. and China, as well as manufacturing rights outside of China.
The therapy has already received fast-track designation from the FDA as a later-line treatment for squamous NSCLC and fits within Takeda’s strategy to build “sustainable leadership” in thoracic, gastrointestinal and hematologic cancers, Bitetti explained. The same deal also saw the Japanese pharma secure exclusive rights outside of China to late-stage gastric and pancreatic antibody-drug conjugate (ADC) prospect IBI343.
“I think the potential is enormous,” she said.
A ‘highly effective’ partnership
Innovent has been busy with U.S. and global pharmas clamoring to make use of its successful development platform and innovative pipeline. Most recently, this involved Pfizer penning a $10 billion deal last week spanning a dozen drugs.
For Takeda, the collaboration with Innovent so far has been “really highly effective and productive,” Morrow told Fierce.
“I think that we really look toward Innovent, not just for their scientific and clinical collaboration, but also to be a leadership partner with us,” she added. According to Morrow, the Chinese biopharma has been “really wonderful” about being “agile” and scientifically driven.
Still, Bitetti emphasized that Takeda’s offer of partnership wasn’t born out of a desire to jump on the China bandwagon.
“We look for innovation across the world, so it's not just a single-minded focus on China,” she said. “We continue to scan the environment for where we can find the best innovation, and it's not always China.”
Innovent just so happened to be “the best next partner for us,” Morrow added, noting that China’s biotechs also offer a “pragmatic look” at where innovation is going.