Takeda Enters Global Strategic Partnership with Innovent Biologics to Bolster Oncology Pipeline with Next-Generation Investigational Medicines for Treatment of Solid Tumors

• Takeda to Receive Rights to Two Next-Generation Late-Stage Investigational Medicines, Worldwide Outside of Greater China, and an Exclusive Option to License Global Rights to an Early-Stage Program
• Takeda to Lead IBI363 Global Co-Development and U.S. Co-Commercialization and Will Have Exclusive Commercialization Rights Outside the U.S. and Greater China; IBI363 is a Late-Stage Bispecific Antibody Fusion Protein Being Evaluated in Non-Small Cell Lung and Colorectal Cancers, with Potential in Additional Solid Tumor Types
• Takeda to Receive Exclusive Rights for IBI343 Outside of Greater China; IBI343 is a Late-Stage Antibody-Drug Conjugate Being Evaluated in Gastric and Pancreatic Cancers
• Takeda Intends to Establish Manufacturing for These Investigational Medicines in the U.S.

Takeda ((TAK) today announced that it has entered into a license and collaboration agreement with Innovent Biologics (HKEX: 01801) for the development, manufacturing and commercialization of two late-stage oncology medicines, IBI363 and IBI343, worldwide outside of Greater China.* IBI363 is being evaluated in non-small cell lung and colorectal cancers and has shown potential efficacy in additional solid tumor types. IBI343 is being evaluated in gastric and pancreatic cancers. Takeda will also receive an exclusive option to license global rights outside of Greater China for IBI3001, an early-stage investigational medicine.

"IBI363 and IBI343, two next-generation investigational medicines, have the potential to address critical treatment gaps for patients with a range of solid tumors," said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. "We are energized by the progress made by Innovent to date and look forward to collaborating to unlock the potential of these programs. Our global research and development expertise and commercialization capabilities will enable us to accelerate the delivery of these investigational medicines to patients. These two programs have the potential to be transformative for our oncology portfolio and significantly enhance Takeda's growth potential post-2030."

IBI363 is a potentially first-in-class investigational PD-1/IL-2^α-bias 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 tumor types, including squamous non-small cell lung cancer (sqNSCLC), non-sqNSCLC and microsatellite stable colorectal cancer (MSS CRC). The U.S. 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 1/2 and three ongoing Phase 2 clinical trials across patient segments and lines of therapy in NSCLC and MSS CRC. A global Phase 3 study in second-line sqNSCLC is expected to begin in the coming months. Clinical development in additional indications is planned for IBI363. Takeda and Innovent will co-develop IBI363 globally with a 60/40 (Takeda/Innovent) cost split and co-commercialize it in the U.S. with a 60/40 (Takeda/Innovent) profit or loss split. Takeda will lead co-commercialization efforts in the U.S. and will have the exclusive right to commercialize IBI363 outside of the U.S. and Greater China. Takeda will have global manufacturing rights to supply IBI363 outside of Greater China, with such rights being co-exclusive with Innovent for commercial supply in the U.S.

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 U.S. 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 3 clinical trial in previously treated gastric cancer in Japan and China and has completed a global Phase 1/2 trial in previously treated pancreatic cancer. Takeda plans to advance the development of IBI343 and expand into the first-line gastric and pancreatic cancer settings. Under the terms of the agreement, Takeda will develop, manufacture and commercialize IBI343 worldwide, outside of Greater China.

"The addition of these programs strengthens our leadership in oncology and enhances Takeda's late-stage pipeline. 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 tumors," said Andy Plump, President, Research and Development, Takeda. "We are encouraged by the clinical results these investigational medicines have shown and look forward to working with Innovent to deliver these potentially best-in-class medicines to patients with longstanding unmet needs across a wide range of cancers."

IBI3001 is a potential first-in-class bispecific ADC designed to target both EGFR and B7H3. It is being studied in an ongoing Phase 1 clinical trial in patients with locally advanced or metastatic solid tumors in the U.S., China and Australia. As part of the agreement, Innovent will be solely responsible for clinical development of IBI3001 prior to potential exercise of the option to license. Should Takeda exercise the option, Takeda will develop, manufacture and commercialize IBI3001 worldwide, outside of Greater China.

"We believe that developing innovative immuno-oncology and ADC therapies will be key for redefining cancer treatment worldwide. We look forward to partnering with Takeda to maximize the potential of our pipeline for patients with a wide variety of cancers," 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 commercialization, moving us closer to offering new options to patients in need."

Innovent will receive a US$1.2 billion upfront payment upon closing of the transaction, which includes an equity investment of US$100 million in Innovent by Takeda. The upfront payment will be funded through cash on hand. Innovent will also be eligible for potential milestones and royalty payments, and a profit or loss split 60/40 (Takeda/Innovent) solely with respect to IBI363 in the U.S., where Takeda will lead the commercialization effort while Innovent will have a co-commercialization right. If Takeda exercises the option for IBI3001, Innovent will be eligible for an option exercise fee and additional potential milestone and royalty payments. The transaction, including any future exercise of the option, is subject to customary closing conditions, including regulatory approvals.

*Mainland China, Hong Kong, Macau and Taiwan.

About IBI363

IBI363 is a potential first-in-class PD-1/IL-2^α-bias bispecific antibody fusion protein. It is designed to block the PD-1/PD-L1 pathway and activate the IL-2 pathway. This IL-2α-biased approach has been shown to target and activate tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation and expansion of this T cell subpopulation without activating nor increasing the toxicity related to peripheral T cells. IBI363 has demonstrated encouraging activity preclinically and in early clinical data in solid tumors, including non-small cell lung cancer and colorectal cancer. Clinical studies in China, the United States and Australia are underway to further explore the efficacy and safety of IBI363 in various areas of unmet need, including newly diagnosed cancers and immune-resistant ("cold") tumors.

About IBI343

IBI343 is a next-generation monoclonal antibody-drug conjugate (ADC) that targets Claudin 18.2-expressing tumor cells. Claudin 18.2 is a protein typically found only in the lining of a healthy stomach, but which is abnormally expressed on the surface of cancer cells in certain tumors, making it a target for new cancer therapies. IBI343 combines an anti-Claudin 18.2 antibody with the cytotoxic agent exatecan, a topoisomerase I inhibitor (TOPO1i). As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 and 2 clinical studies in gastric cancer and pancreatic cancer.

About IBI3001

IBI3001 is a potential first-in-class bispecific antibody-drug conjugate (ADC) that comprises a bispecific antibody targeting EGFR and B7H3 antigens and an exatecan payload. Both EGFR and B7H3 promote cancer and are co-expressed in multiple solid tumors. In addition to the cytotoxic effects of the payload and strong bystander killing effect, IBI3001 has been shown to block EGFR signaling. In preclinical testing, it demonstrated in vitro and in vivo anti-tumor activity across multiple cancer types.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common type of cancer and the leading cause of cancer-related death globally, posing a significant public health challenge.¹ Non-small cell lung cancer (NSCLC) accounts for at least 85% of all lung cancer cases.¹ In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC.² However, for patients who lack actionable driver mutations and who progress after immunotherapy, there remains a significant and urgent unmet need for effective treatment options.²

About Microsatellite Stable Colorectal Cancer (MSS CRC)

Colorectal cancer (CRC) is the third most common type of cancer and is the second leading cause of cancer-related death globally.³ Accounting for approximately 80-85% of all colorectal cancers, microsatellite stable (MSS) tumors have low mutation rates, which limit the immune system's ability to recognize and attack them, leading to poor clinical outcomes with immunotherapy.^4,5 Without new immuno-oncology treatment options, treatment of MSS CRC is primarily limited to traditional chemotherapy, representing a significant unmet clinical need.⁶

About Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic cancer is one of the most challenging-to-treat tumors of the digestive system; for all stages combined, the 5-year relative survival rate is approximately 13%.^7,8 For advanced pancreatic cancer, systemic chemotherapy remains the cornerstone of treatment.⁸ Claudin 18.2, a protein that can be expressed in certain types of cancer cells and can promote cancer growth, is present in a high percentage of pancreatic cancer patients.^9,10

About Gastric Cancer

Gastric cancer is the fifth most common cancer and the fourth leading cause of cancer-related deaths globally.¹¹ The 5-year relative survival rate for patients with gastric cancer is approximately 36%, though this varies according to stage.¹² Claudin 18.2, a protein that can be expressed in certain types of cancer cells, is present in a sizable proportion of patients with gastric cancer.¹³ Claudin 18.2 can promote cancer growth.¹⁰

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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References:

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