Efficacy and Biomarker Explanation of IBI-323 Combined With Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged Non-Small Cell Lung Cancer Who Failed From First Line Alectinib

This study aimed to explore the efficacy and biomarker explanation of IBI-323 combined with bevacizumab plus platinum based chemotherapy on ALK-rearranged non-small cell lung cancer who failed from first line Alectinib.

Start Date25 Dec 2023

Sponsor / Collaborator

Hunan Cancer Hospital

CTR20211221 / RecruitingPhase 1

评估IBI323治疗晚期恶性肿瘤的安全性、耐受性和有效性的开放、多中心、I期研究

[Translation] An open-label, multicenter, Phase I study to evaluate the safety, tolerability, and efficacy of IBI323 in the treatment of advanced malignancies

评估IBI323在晚期肿瘤受试者中的安全性、耐受性、抗肿瘤活性、药代动力学特征和免疫原性。探索sLAG-3水平和变化，探索iRECIST进行疗效评估，探索肿瘤组织中潜在预测疗效的生物标志物

[Translation]

Evaluate the safety, tolerability, anti-tumor activity, pharmacokinetic characteristics and immunogenicity of IBI323 in subjects with advanced tumors. Explore sLAG-3 levels and changes, explore iRECIST for efficacy evaluation, and explore potential biomarkers in tumor tissues to predict efficacy

Start Date29 Jun 2021

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT04916119 / RecruitingPhase 1

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IBI323 in Participants With Advanced Malignancies

The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323

Start Date29 Jun 2021

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with IBI-323

100 Translational Medicine associated with IBI-323

100 Patents (Medical) associated with IBI-323

Literatures (Medical) associated with IBI-323

01 Jan 2021·OncoImmunologyQ2 · MEDICINE

PD-L1/LAG-3 bispecific antibody enhances tumor-specific immunity

Q2 · MEDICINE

ArticleOA

Author: Zhou, Shuaixiang ; Wu, Weiwei ; Ni, Haiqing ; Yu, Michael ; Guo, Xiaoli ; Wu, Min ; Wang, Jie ; Liu, Junjian ; Tang, Rong ; Zhang, Pan ; Jiang, Haiping ; Shen, Haoran ; Chen, Bingliang ; Jing, Hua ; Ding, Jiazheng ; Wu, Zhihai

Anti-programmed cell death-1 (PD-1)/PD-ligand-1 (PD-L1) treatments are effective in a fraction of patients with advanced malignancies. However, the majority of patients do not respond to it. Resistance to cancer immunotherapy can be mediated by additional immune checkpoints. We hypothesized that co-targeting of PD-L1 and lymphocyte-activation gene 3 (LAG-3) could provide an alternative therapeutic approach. Here, we developed IBI323, a dual blockade bispecific antibody targeting PD-L1 and LAG-3. We assessed the binding affinity, blocking activity, cell bridging effect, and immunomodulation function of IBI323 using in vitro assays. We also evaluated, in two humanized mouse models, anti-tumor effects and antitumor T cell immunity induced by IBI323. IBI323 bound to PD-L1 and LAG-3 with similar potency as its parental antibodies and blocked the interaction of PD-1/PD-L1, CD80/PD-L1, and LAG-3/MHC-II. Moreover, IBI323 mediated the bridging of PD-L1+ cells and LAG-3+ cells and demonstrated superior immune stimulatory activity compared to each parent antibody in mixed leukocyte reaction. In PD-L1/LAG-3 double knock-in mice bearing human PD-L1 knock-in MC38 tumors, IBI323 showed stronger anti-tumor activity compared to each parental antibody. The better antitumor response correlated with increased tumor-specific CD8+ and CD4+ T cells. IBI323 also induced stronger anti-tumor effect against established A375 tumors compared with combination in mice reconstituted with human immune cells. Collectively, these data demonstrated that IBI323 preserved the blockade activities of parental antibodies while processing a novel cell bridging function. Based on the encouraging preclinical results, IBI323 has significant value in further clinical development.

100 Deals associated with IBI-323

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	29 Jun 2021

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