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Innovent Biologics to Present Breakthrough Clinical Data for IBI363 PD-1/IL-2 Bispecific Antibody at ASCO 2025

3 months ago4 min read

Key Insights

  • Innovent Biologics will showcase seven oral presentations at ASCO 2025, featuring breakthrough clinical data for its novel PD-1/IL-2α-bias bispecific antibody IBI363 in melanoma, colorectal cancer, and non-small cell lung cancer.

  • IBI343, Innovent's anti-CLDN18.2 antibody-drug conjugate, secured an oral presentation slot for its Phase 1b data in pancreatic cancer, demonstrating promising potential in this difficult-to-treat malignancy.

  • The company's robust pipeline of bispecific antibodies and ADCs highlights Innovent's growing position as a leader in the "IO+ADC" space, with multiple candidates advancing toward pivotal-stage development.

Innovent Biologics announced that it will present breakthrough clinical data for multiple innovative bispecific antibodies and antibody-drug conjugates (ADCs) at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3, 2025, in Chicago.
The company's presentations will feature seven oral presentations, including three focused on IBI363, Innovent's novel PD-1/IL-2α-bias bispecific antibody fusion protein, across different cancer types. Additionally, IBI343, an anti-CLDN18.2 ADC, will be featured in an oral presentation for pancreatic cancer.

IBI363: A First-in-Class PD-1/IL-2α-Bias Bispecific Antibody

IBI363 represents a significant advancement in cancer immunotherapy by combining PD-1 blockade with IL-2 pathway activation in a single molecule. The bispecific antibody has secured three separate oral presentation slots at ASCO 2025, highlighting its potential across multiple tumor types:
  • Advanced Acral and Mucosal Melanoma: Data will be presented by Dr. Jun Guo from Beijing Cancer Hospital, focusing on efficacy and safety in patients previously treated with immunotherapy.
  • Advanced Colorectal Cancer: Dr. Zhenyu Lin from Union Hospital will present results from IBI363 monotherapy and combination therapy with bevacizumab, addressing a tumor type traditionally considered resistant to immunotherapy.
  • Non-Small Cell Lung Cancer: Dr. Jianya Zhou from Zhejiang University School of Medicine will present data on IBI363 in patients with advanced NSCLC previously treated with immunotherapy.
Dr. Hui Zhou, Senior Vice President of Innovent, emphasized the significance of these presentations: "The first wave of three indications under development for IBI363 have all been accepted for oral presentations, highlighting the significant attention garnered by next-generation bispecific antibodies, in particular PD-1-based immunotherapy."

IBI343: Promising ADC for Gastrointestinal Cancers

IBI343, an anti-CLDN18.2 antibody-drug conjugate, will be featured in an oral presentation by Dr. Xianjun Yu from Fudan University Shanghai Cancer Center. The presentation will focus on CLDN18.2 expression and efficacy in pancreatic ductal adenocarcinoma from a Phase 1 dose expansion cohort.
This marks the second major conference where IBI343 data in pancreatic cancer has secured an oral presentation slot, following its presentation at ESMO Asia last December. Pancreatic cancer remains one of the most challenging malignancies to treat, with limited therapeutic options and poor survival rates.

Additional Presentations Highlight Pipeline Breadth

Beyond IBI363 and IBI343, Innovent will present data on several other programs:
  • Sintilimab (anti-PD-1): Results from the Phase 3 ORIENT-21 study in classical Hodgkin lymphoma and the SPRING-01 trial in locally advanced rectal cancer.
  • IBI354 (anti-HER2 ADC): Updated results from Phase 1 trials in ovarian cancer, breast cancer, and other solid tumors.
  • IBI130 (anti-TROP2 ADC): Safety and efficacy data in patients with advanced triple-negative breast cancer and other solid tumors.
The company will also present a trial-in-progress poster for a Phase 3 study of arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma.

Advancing the "IO+ADC" Strategy

Innovent's strong presence at ASCO 2025 underscores its strategic focus on developing both immunotherapy agents and antibody-drug conjugates. The company has positioned itself as one of the few biopharmaceutical organizations with advanced technology platforms and robust pipelines in both areas.
"The maturing proof-of-concept data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs," Dr. Zhou stated.

About Innovent Biologics

Founded in 2011, Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for oncology, cardiovascular and metabolic, autoimmune, ophthalmology, and other major diseases. The company has launched 15 products in the market, with 3 new drug applications under regulatory review and 4 assets in Phase III or pivotal clinical trials.
Innovent has established partnerships with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem, and MD Anderson Cancer Center. The company's mission is to empower patients worldwide with affordable, high-quality biopharmaceuticals.
With its motto "Start with Integrity, Succeed through Action," Innovent aims to maintain the highest standard of industry practices while advancing the biopharmaceutical industry to make first-rate pharmaceutical drugs widely accessible.
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2025 ASCO - Leads Biolabs - 维立志博

en.leadsbiolabs.comFeb 6, 2025

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