2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Date of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from Phase 1 Clinical Studies in Advanced Colorectal Cancer
SAN FRANCISCO, and SUZHOU, China, June 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) monotherapy and combo-therapy with bevacizumab in advanced colorectal cancer were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI363 demonstrated encouraging response and overall survival benefit in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, supports its unique mechanism of actions (MoA) of turning 'cold tumor' into 'hot tumor'.
Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited.
PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 monotherapy and combined with bevacizumab in participants with advanced colorectal cancer: results from Phase 1 studies
Two Phase 1 studies (NCT05460767, NCT06717880) were conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 monotherapy and combined with bevacizumab in patients with advanced colorectal cancer.
IBI363 monotherapy has demonstrated breakthrough antitumor therapeutic potential, showing a significant extension of overall survival compared to data of standard-of-care therapies
The combination of IBI363 and bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile, with excellent data on objective response rate and progression-free survival
Tumor immune cell infiltration analysis supports the IBI363 MOA of turning 'cold tumor' into 'hot tumor', demonstrating enrichment of PD1+CD25+CD8+ cells in baseline tumor tissue association with clinical efficacy
Professor Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: 'Colorectal cancer is the third most common cancer type globally and ranks fourth in cancer-related mortality4. About 86% of colorectal cancer are in an immune 'desert' or immune-inflamed suppressed state, rendering traditional immune checkpoint inhibitors (ICIs) ineffective5. For colorectal cancer that has failed standard treatments, there are limited therapeutic options with short survival periods, representing a significant unmet clinical need6. IBI363, as a PD-1/IL-2α-bias bispecific fusion protein, has demonstrated robust antitumor efficacy in preclinical studies through the effective expansion of tumor-specific CD8⁺ T cells (TST cells). Its ability to block PD-1 and stimulate TST cells holds the potential to transform 'cold' tumors into 'hot' tumors. As a monotherapy, IBI363 achieves a median survival of 16.1 months in later-line treatments, which represents a significant improvement compared to the median survival of current standard therapies and also confirms its potential with a strong 'tail effect' as a PD1 plus cytokine bispecific immunotherapy. The combination of IBI363 with bevacizumab is still under continuous follow-up, having shown promising efficacy and tolerable safety, with unique efficacy characteristics particularly in the subgroup without liver metastasis. Overall, clinical data suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and warrants further exploration.'
Dr. Hui Zhou, Senior Vice President of Innovent, stated: 'On top of the preliminary data reported at 2024 ASCO and 2024 ESMO, we are presenting more updated follow-up data and combination therapy results of IBI363 at the ASCO Congress this year. From a comprehensive body of clinical evidence that includes ORR, PFS, OS, IBI363 demonstrated robust antitumor activity of both monotherapy and combination therapy in patients with advanced colorectal cancer who are non-MSI-H/dMMR. We are eyeing on long-term survival data from high dose in longer follow-up period. And the pivotal study of IBI363 targeting advanced CRC is in plan. Observing such results in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, further highlights the broad development potential of IBI363. It offers hope for expanding into areas where immunotherapy has been less effective or even unresponsive.'
About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models.
In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.
IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively.
About Innovent
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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
References
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