Pharmaceutical company Takeda has announced it has entered a global strategic partnership with biotechnology company Innovent Biologics to develop next-generation medicines for cancer tumours. 

The agreement will see the development, manufacturing and commercialisation of two late-stage oncology medicines, IBI363 and IBI343, worldwide outside of Greater China. IBI63 is being evaluated in non-small cell lung and colorectal cancers and IBI343 is being evaluated in gastric and pancreatic cancers. 

“IBI363 and IBI343, two next-generation investigational medicines, have the potential to address critical treatment gaps for patients with a range of solid tumours,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda.  

“Our global research and development expertise and commercialisation capabilities will enable us to accelerate the delivery of these investigational medicines to patients. These two programmes have the potential to be transformative for our oncology portfolio and significantly enhance Takeda’s growth potential post-2030.” 

The potential of IBI363 and IBI343

IBI363 is a potentially first-in-class investigational PD-1/IL-2 bispecific antibody fusion protein. In early studies where more than 1,200 patients received IBI363, including patients who were refractory to PD-1/L1 therapy, it has shown promising clinical activity in several solid tumour types, including squamous non-small cell lung cancer (sqNSCLC), non-sqNSCLC and microsatellite stable colorectal cancer (MSS CRC). 

The US Food and Drug Administration (FDA) has granted Fast Track designation to IBI363 for the treatment of patients with unresectable, locally advanced or metastatic sqNSCLC that has progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. IBI363 is being studied globally in an ongoing Phase I/II trial and three ongoing Phase II clinical trials across patient segments and lines of therapy in NSCLC and MSS CRC. 

IBI343 is a next-generation investigational antibody-drug conjugate (ADC) that targets the Claudin 18.2 protein, which is often expressed in gastric and pancreatic cancer cells. IBI343 has shown promising clinical activity in studies in gastric cancer and advanced pancreatic cancer, in which more than 340 patients were treated with IBI343. These cancers have among the lowest five-year survival rates. 

The US FDA has granted Fast Track designation to IBI343 for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. IBI343 is currently being evaluated in an ongoing Phase III clinical trial in previously treated gastric cancer in Japan and China and has completed a global Phase I/II trial in previously treated pancreatic cancer. 

Under the agreement, Takeda will have global manufacturing rights to supply IBI363 outside of Greater China and will advance the development of IBI343 into first-line gastric and pancreatic cancer settings. 

“The addition of these programmes strengthens our leadership in oncology and enhances Takeda’s late-stage pipeline,” said Andy Plump, President of Research and Development at Takeda. “Drawing from our deep experience in oncology and the modalities leveraged by IBI363 and IBI343, we are uniquely positioned to partner with Innovent to accelerate and expand the potential of these investigational medicines in a range of solid tumours.” 

IBI3001 could bring ‘new options to patients in need’

Under the terms of the partnership, Takeda will also receive an exclusive option to license global rights outside of Greater China for IBI3001, an early-stage investigational medicine. IBI3001 is currently being studied in an ongoing Phase I clinical trial in patients with locally advanced or metastatic solid tumours in the US, China and Australia. 

“We believe that developing innovative immuno-oncology and ADC therapies will be key for redefining cancer treatment worldwide,” said Dr Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics.  

“These investigational therapies, featuring innovative mechanisms of action, have shown promise for patients who currently have limited treatment options. Our collaboration is poised to advance their development and potential commercialisation, moving us closer to offering new options to patients in need.” 

 

Bruno Quinney, Content Team, DDW