A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

Start Date20 Jun 2022

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

NCT05805956 / RecruitingPhase 1/2

An Open-label, Multicenter, First-in-human Dose-escalation and Cohort Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMM2902 in the Treatment of HER2-expressing Advanced Solid Tumors

This trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors

Start Date15 Feb 2022

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

CTR20212375 / SuspendedPhase 1/2

一项开放、多中心、首次人体的剂量递增和队列扩展的I/II期临床研究，旨在评价IMM2902治疗HER2表达的晚期实体瘤的安全性、耐受性和初步有效性

[Translation] An open-label, multicenter, first-in-human, dose-escalation and cohort expansion Phase I/II clinical study designed to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors

主要研究目的：观察IMM2902在人类表皮生长因子受体2（HER2）表达的晚期实体瘤患者中的安全性和耐受性，从而确定IMM2902单药治疗的最大耐受剂量（MTD）和2期推荐剂量（RP2D）（I期）。评价IMM2902在HER2表达的晚期实体瘤患者中的初步抗肿瘤疗效；次要研究目的评价IMM2902在HER2表达晚期实体瘤患者体内的药代动力学（PK）特征；评价IMM2902在HER2表达的晚期实体瘤患者中的免疫原性。探索性研究目的探索IMM2902的暴露量与效应和安全性的相关性关系；探索受试者肿瘤组织基线HER2表达水平与疗效的相关性关系；探索受试者给药后外周血中细胞因子表达和疗效的相关性关系；探索受试者给药后外周血中淋巴细胞亚群分布特征与疗效的相关性关系。

[Translation]

Main study objectives: Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the maximum tolerated dose (MTD) and recommended dose (RP2D) (Phase I) of IMM2902 monotherapy. Evaluate the preliminary anti-tumor efficacy of IMM2902 in patients with advanced solid tumors expressing HER2; Secondary study objectives Evaluate the pharmacokinetic (PK) characteristics of IMM2902 in patients with advanced solid tumors expressing HER2; Evaluate the immunogenicity of IMM2902 in patients with advanced solid tumors expressing HER2. Exploratory study objectives Explore the correlation between the exposure of IMM2902 and the effect and safety; Explore the correlation between the baseline HER2 expression level of the tumor tissue of the subjects and the efficacy; Explore the correlation between the expression of cytokines in the peripheral blood of the subjects after administration and the efficacy; Explore the correlation between the distribution characteristics of lymphocyte subsets in the peripheral blood of the subjects after administration and the efficacy.

Start Date24 Jan 2022

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

100 Clinical Results associated with Vislarafusp alfa

100 Translational Medicine associated with Vislarafusp alfa

100 Patents (Medical) associated with Vislarafusp alfa

Literatures (Medical) associated with Vislarafusp alfa

01 May 2024·Drug Resistance Updates

Development and evaluation of a human CD47/HER2 bispecific antibody for Trastuzumab-resistant breast cancer immunotherapy

Article

Author: Ji, Zhenyu ; Gao, Le ; Li, Song ; Xu, Linping ; Fan, Dandan ; Wang, Fang ; Song, Yongping ; Tian, Wenzhi ; Bian, Zhilei ; Jin, Shuiling ; Liu, Mengmeng ; Shi, Jianxiang ; Zheng, Yichao ; Shi, Xiaojing ; Li, Wei ; Xu, Xiaolu ; Zhang, Binglei ; Zhou, Jian ; Gao, Mengya

The treatment for trastuzumab-resistant breast cancer (BC) remains a challenge in clinical settings. It was known that CD47 is preferentially upregulated in HER2⁺ BC cells, which is correlated with drug resistance to trastuzumab. Here, we developed a novel anti-CD47/HER2 bispecific antibody (BsAb) against trastuzumab-resistant BC, named IMM2902. IMM2902 demonstrated high binding affinity, blocking activity, antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and internalization degradation effects against both trastuzumab-sensitive and trastuzumab-resistant BC cells in vitro. The in vivo experimental data indicated that IMM2902 was more effective than their respective controls in inhibiting tumor growth in a trastuzumab-sensitive BT474 mouse model, a trastuzumab-resistant HCC1954 mouse model, two trastuzumab-resistant patient-derived xenograft (PDX) mouse models and a cord blood (CB)-humanized HCC1954 mouse model. Through spatial transcriptome assays, multiplex immunofluorescence (mIFC) and in vitro assays, our findings provided evidence that IMM2902 effectively stimulates macrophages to generate C-X-C motif chemokine ligand (CXCL) 9 and CXCL10, thereby facilitating the recruitment of T cells and NK cells to the tumor site. Moreover, IMM2902 demonstrated a high safety profile regarding anemia and non-specific cytokines release. Collectively, our results highlighted a novel therapeutic approach for the treatment of HER2⁺ BCs and this approach exhibits significant anti-tumor efficacy without causing off-target toxicity in trastuzumab-resistant BC cells.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	15 Feb 2022
Advanced gastric carcinoma	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	15 Feb 2022
HER2-Expressing Cancers	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	15 Feb 2022
Lung Cancer	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	15 Feb 2022
Advanced Malignant Solid Neoplasm	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	24 Jan 2022
Advanced breast cancer	Phase 1	US	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	20 Jun 2022
HER2 Positive Solid Tumors	Phase 1	US	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	20 Jun 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2023	Phase 1	HER2-Expressing Cancers	16	IMM2902	(ybgvbvqtok) = One SAE (grade 3 gastrointestinal hemorrhage) was reported, which was unrelated to IMM2902. uhjffnfqgn (gszlytxbjr )	Positive	31 May 2023

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