Innovent Reports Oncology Pipeline Updates at Investor Meeting

Oncology pipeline development strategy: extensively deploy “IO + ADC” to solve unmet clinical needs worldwide

Scientific and technological advancements have steadily increased cancer patient survival rates and quality of life. However, many unmet clinical needs persist in cancer treatment. These include the limited response rates to immunotherapies like PD-1, with most responses resulting in relapse or resistance. Additionally, the effectiveness of current mainstream treatment, such as anti-angiogenic drugs, remains limited. Significant unmet needs continue to drive further innovation in oncology drug development.

Innovent has built a product pipeline of 36 new drug candidates, including 22 in oncology. Utilizing a world-leading antibody technology platform, differentiated linker-payloads and deep scientific expertise in oncology, Innovent has extensively deployed a combination of immune-oncology (IO) and antibody-drug conjugates (ADCs). This comprehensive “IO + ADC” approach aims to drive global innovation and enhance the brand positioning for the Company’s oncology pipeline, which strives to “further life’s possibilities.”

Key product milestones: PoC + MRCT driving the globalization of innovative therapies

The Company is progressing its innovative oncology pipeline through clinical proof-of-concept (PoC) studies and global multi-regional clinical trials (MRCT). Several high-potential molecules have now entered clinical development, including the three novel candidates IBI363, IBI343 and IBI389, which were discussed in detail on the call. Innovent also has additional bispecific antibody and ADC candidates advancing in early global clinical development.

IBI363: First-in-class PD-1/IL-2 ^α-bias bispecific antibody fusion protein shows promising anti-tumor efficacy across multiple cancer types, including in immunotherapy-treated and ‘cold’ tumors, signaling the emergence of a potential next-generation IO therapy

• IBI363 represents Innovent’s continuous research and innovation in immuno-oncology. At this meeting, Innovent reported for the first time on IBI363’s novel mechanical of action and provided updates on its clinical development progress.
• Regarding its molecular design, ICI363 creatively employs an α-biased approach while weakening β and γ signaling, significantly improving the therapeutic window of IL-2. Through specific binding to PD-1, it can selectively stimulate and amplify tumor-specific T cells that co-express PD-1 and CD25, thereby exerting an anti-tumor effect. The novel design leverages the cytokine’s activating potential while mitigating systemic toxicity.
• IBI363 exhibits excellent drug-like properties, demonstrating antibody-like pharmacokinetics (IgG-like PK) and low immunogenicity. This allows for unprecedented dosing levels of IBI363 while maintaining a favorable safety profile, overcoming the toxicity concerns typically associated with IL-2 therapy.
• In the Phase 1 clinical trials involving over 300 subjects, IBI363 demonstrated encouraging anti-tumor efficacy across multiple representative cancer types, including immunotherapy-treated driver gene wild-type non-small cell lung cancer, immunotherapy-treated melanoma, immunotherapy treatment-naïve mucosal melanoma, and the immunologically ‘cold’ colorectal cancer. These results highlight IBI363’s broad-spectrum anti-tumor potential across diverse tumor types and treatment settings.
• Building on the encouraging clinical data, Innovent is further expanding IBI363’s clinical development, including continued evaluation of the 3mg/kg high dose cohort to determine the optimal dose for subsequent studies, initiating Phase 2 trials in the United States, and exploring additional combination therapy opportunities to broaden IBI363’s potential applications.

Two CLDN18.2-target based innovative technology modalities, IBI343 and IBI389, showed initial breakthrough efficacy

IBI343: Innovative TOPO1i CLDN18.2 ADC, the world’s first ADC drug to show initial breakthrough efficacy in pancreatic cancer

• IBI343 is a world-leading innovative TOPO1-inhibitor CLDN18.2 ADC that features an excellent molecular design utilizing world-class specific glycoconjugate technology for high in vivo stability. IBI343 binds to the Claudin 18.2-expressing tumor cells, which causes Claudin 18.2-dependent ADC internalization to occur. Meanwhile, the high potency payload (exatecan) is used with strong bystander killing effect. Notably, its Fc-silenced design mitigates ADCC-mediated gastrointestinal toxicity, ensuring a high safety profile. This integrated design positions IBI343 at the forefront of innovative CLDN18.2-targeted ADCs.
• The world’s first ADC single agent to show breakthrough efficacy in pancreatic cancer: Preliminary Phase 1 data of IBI343 in pancreatic cancer patients who had received at least one line of treatment showed that the objective response rate (ORR) was 40% in CLDN18.2 IHC1/2/3+≥60% pancreatic cancer patients (n=10) who received 6 mg/kg IBI343.
• In addition to pancreatic ductal adenocarcinoma (PDAC), IBI343 has shown strong anti-tumor effects in the treatment of late-line gastric cancer, and its Phase 3 MRCT clinical trial is under preparation.

IBI389 (anti-CLDN18.2/CD3 bispecific antibody): First-in-class T-cell engager with anti-tumor activity observed in pancreatic cancer

• IBI389 is an anti-CLDN18.2 T cell-engaging bispecific antibody developed by Innovent. It induces immune synapse formations by linking CD3 molecules in T-cell receptor complexes and CLDN18.2 antigens on the surfaces of tumor cells. IBI389 stimulates T-cell activation, resulting in cytolytic protein production, inflammatory cytokine release and further T-cell proliferation, which eventually leads to durable anti-tumor effects. Preclinical results show that even in cell lines with low expression of CLDN18.2, IBI389 can still bind to tumor cells and show significant anti-tumor efficacy.
• IBI389 has shown promising efficacy signals in advanced gastric and pancreatic cancers, including cases with low to medium CLDN18.2 expression. Notably, as the world’s first bispecific antibody targeting CLDN18.2/CD3 to publish clinical data, IBI389 has shown significant initial anti-tumor effects in pancreatic cancer, marking a breakthrough for this innovative drug form in the field of difficult-to-treat cancers.
• ASCO clinical data showed that among 27 pancreatic cancer subjects who received 600μg/kg IBI389 and underwent at least one post-baseline tumor assessment, the objective response rate (ORR) was 29.6%, the confirmed objective response rate (cORR) was 25.9%, and the disease control rate (DCR) was 70.4%. Among the 18 subjects with CLDN18.2 IHC 2/3+≥40%, the cORR reached 38.9%.
• Based on the unique advantages of IBI343 and IBI389 demonstrated in early clinical trials, Innovent is advancing the development of IBI343 for the MRCT Phase 3 clinical trial in gastric cancer. Additionally, the Company is moving forward with proof-of-concept clinical studies of both IBI343 and IBI389 in the difficulty-to-treat pancreatic cancer.

Looking ahead, Innovent will continue to advance the high-quality clinical development of its oncology product line, address unmet medical needs in cancer treatment and promote global innovation guided by its “IO + ADC” strategy.

Dr. Hui Zhou, Senior Vice President of Oncology Development at Innovent Biologics, said: “As one of the few biopharmaceutical companies with leading R&D capabilities in both IO and ADC, we possess a unique competitive advantage in next-generation oncology treatment innovations. We will adhere to our mission of empowering patients worldwide with affordable, high-quality biopharmaceuticals, aiming to benefit even more patients and support the Healthy China 2030 initiative.”

Detailed sharing materials can be downloaded from the company’s official website, link: https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/

About Innovent Biologics:

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, ‘Start with Integrity, Succeed through Action,’ Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

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SOURCE Innovent Biologics