SAN FRANCISCO and SUZHOU, China, Sept. 10, 2024
SAN FRANCISCO and SUZHOU, China, Sept. 10, 2024 /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, announced the presentation of Phase 1 clinical data (ClinicalTrials.gov, NCT04085185) for IBI363 (first-in-class PD-1/IL-2a-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2024 World Conference on Lung Cancer (WCLC). Currently, Innovent is conducting Phase 1/2 clinical trials in China, U.S. and Australia to evaluate the safety, tolerability and efficacy of IBI363 in subjects with advanced solid tumors.
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First-in-class PD-1/IL-2a-bias bispecific antibody IBI363 in patients with advanced non-small cell lung cancer in a Phase 1 study
Patients with at least 1 tumor assessment
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sqNSCLC
1/1.5 mg/kg(N=27)
3 mg/kg(N=29)
3 mg/kg
with at least 12 weeks of follow-up(N=18)
Best overall response, n (%)
Partial Response (PR)
6*
10**
9***
Stable Disease (SD)
13
16
7
Progressive Disease (PD)
8
2
2
Not Evaluable (NE)
0
1
0
ORR, % (95% CI)
22.2% (8.6, 42.3)
34.5% (17.9, 54.3)
50.0% (26.0, 74.0)
DCR, % (95% CI)
70.4% (49.8, 86.2)
89.7% (72.6, 97.8)
88.9% (65.3, 98.6)
*6 patients had confirmed PR; **9 out 10 patients had confirmed PR; ***8 of 9 patients had confirmed PR.
Given that IBI363 has shown encouraging efficacy signals and good tolerability, this study continues to investigate the long-term efficacy and safety and to determine the RP2D in NSCLC. Additional studies are also underway to evaluate IBI363 in combination with other therapies and in other solid tumors. Relevant data and analyses will be shared in future academic conferences or publications.
Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the leading cause of cancer-related deaths globally, with non-small cell lung cancer accounting for approximately 80% of cases[1]. While PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer, most patients eventually develop primary or secondary resistance to these immune checkpoint inhibitors. For NSCLC patients who fail IO therapy, effective treatment options are limited, with chemotherapy, such as docetaxel, achieving only about an ORR of 10% and a median PFS of under 4 months[2]. As a key cytokine that activates tumor-specific CD8+T cells, IL-2 complements immune checkpoint inhibitors in its MOA. Combining PD-1 with IL-2 may reverse the exhaustion of tumor-specific CD8+ T cells and help overcome immune resistance. As a PD-1/IL-2a-bias bispecific molecule, IBI363 has demonstrated promising antitumor activity in IO-resistant, driver gene wild-type NSCLC, with clinical benefits shown in both ORR and PFS. Additionally, its manageable safety profile, even at higher doses, provides confidence in its therapeutic potential."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present the latest data on IBI363 in lung cancer at WCLC. The data highlights the promising trend of IBI363 showing better ORR and DCR at higher doses, alongside a manageable safety profile. Although the follow-up period for the 3 mg/kg dose group is still relatively short, we anticipate more mature data from longer-term follow-up and expect to see its potential as an immunotherapy for long-term survival benefits to patients. Meanwhile, in non-small cell lung cancer, particularly in IO-treated squamous NSCLC, IBI363 has demonstrated potent anti-tumor effects regardless of PD-L1 expression levels. This indicates that IBI363 could potentially offer breakthroughs in treating cold tumors with low or absent PD-L1 expression. We will continue to advance the clinical exploration of IBI363 in squamous NSCLC and other tumor types."
About IBI363 (First-in-class PD-1/IL-2a-bias bispecific antibody fusion protein)
IBI363 is a first-in-class PD-1/IL-2a-bias bispecific antibody fusion protein developed independently 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-2Ra while reducing binding to IL-2Rß and IL-2R?, 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-2Ra, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, including those resistant to PD-1 resistance and models of metastasis. 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 advanced tumors.
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 11 products in the market. It has 3 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.
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
[1] Sung H, Ferlay J, Siegel R L, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA: a cancer journal for clinicians, 2021, 71(3): 209-249.
[2] TROPION-Lung01 ESMO 2023
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