Innovent Doses First Patient in Phase 1 Study of IBI3020 for Advanced Cancers

SAN FRANCISCO and SUZHOU, China, April 29, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent"), a prominent biopharmaceutical company, has announced the successful initial dosing of the first patient with IBI3020, a pioneering dual-payload CEACAM5 ADC, as part of a Phase 1 clinical trial. This trial targets patients with advanced solid tumors. Notably, IBI3020 is the first dual-payload ADC developed using Innovent's proprietary DuetTx® platform and represents the first globally recognized ADC of its class to achieve initial human dosing.

The Phase 1 study is structured as an open-label, multi-regional effort focusing on the safety, tolerability, and preliminary efficacy of IBI3020 in individuals with advanced solid tumors. Additionally, the study aims to establish the recommended Phase 2 dose (RP2D). With recent IND approval in the U.S., the study will be conducted across China and the U.S.

As an innovative global first-in-class ADC candidate, IBI3020 emerges from Innovent's proprietary DuetTx® platform. The international application of the CEACAM5-dependent ADC is facilitated by IBI3020's selective binding to CEACAM5-expressing tumor cells, which is followed by lysosomal breakdown. This process activates two types of cytotoxic payloads, resulting in the destruction of tumor cells.

In preclinical settings, IBI3020 has shown significant antitumor activity across various pharmacological models, including a noteworthy bystander killing effect. It also exhibited favorable safety profiles in preclinical trials, highlighting an overall manageable safety framework.

Professor Yu Jinming from Shandong Cancer Hospital explained that Carcinoembryonic antigen (CEA), or CEACAM5, is a glycoprotein involved in cancer cell adhesion, invasion, and metastasis. There is a pressing clinical demand for effective treatments for advanced colorectal, non-squamous lung, gastric, and pancreatic cancers. CEACAM5's high expression in these tumors, coupled with its limited expression in healthy tissues, makes it a potentially safe and viable therapeutic target. The dual payload of IBI3020 consists of clinically validated payloads, enhancing tumor-killing efficiency in preclinical studies. Expectations are high for IBI3020 to demonstrate safety, tolerability, and efficacy in clinical trials.

Dr. Hui Zhou, Senior Vice President of Innovent, expressed satisfaction with the successful dosing of the first patient. He emphasized Innovent's commitment to advancing the global development of IBI3020 to provide improved treatment options for patients with advanced solid tumors. Innovent boasts innovative ADC technology platforms with independent intellectual property rights, and several ADC molecules have clinically validated their unique competitive advantages. IBI3020, Innovent's first dual-payload ADC, has entered clinical trials, marking a significant breakthrough in the company's ADC technology. Innovent remains focused on its "IO+ADC" strategy, striving for next-generation innovations with global potential to benefit cancer patients worldwide.

IBI3020 represents a pioneering ADC candidate developed from Innovent's proprietary DuetTx® platform. The CEACAM5-dependent ADC internalization happens when IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation, releasing two types of cytotoxic payloads and leading to tumor cell destruction.

The multi-regional Phase 1 study of IBI3020, initiated in China, evaluates its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors, aiming to determine the recommended Phase 2 dose (RP2D). The study, which has also received U.S. IND approval, will be conducted in both China and the U.S.

Innovent, established in 2011, is dedicated to providing patients worldwide with affordable, high-quality biopharmaceuticals. The company develops and commercializes innovative medicines targeting some of the most challenging diseases, including cancer, cardiovascular, autoimmune, and eye diseases. Innovent has introduced 15 products to the market, with three new drug applications under regulatory review, three assets in Phase III clinical trials, and 16 more in early clinical stages. Innovent collaborates with over 30 global healthcare companies to advance the biopharmaceutical industry and ensure widespread access to top-tier pharmaceutical drugs.