Delving into the Latest Updates on FDA022 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

anti-HER2 ADC(Shanghai Fudan-Zhangjiang Bio-Pharmaceutical), 抗Her2抗体偶联BB05

+ [2]

Target

HER2 x Top I

Mechanism

HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases

Active Indication

Advanced Malignant Solid NeoplasmHER2 Positive Breast CancerHER2-expressing Gastroesophageal Junction Adenocarcinoma

Inactive Indication-

Originator Organization

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

Active Organization

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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评估FDA022-BB05在多种晚期实体瘤患者中的安全性和耐受性；初步评估FDA022-BB05在多种晚期实体瘤患者中的抗肿瘤疗效（应用实体瘤疗效评价标准（RECIST 1.1））；应用实体瘤疗效评价标准（RECIST 1.1）评估FDA022-BB05在晚期实体瘤患者中的疗效；评估FDA022-BB05在晚期实体瘤患者中的免疫原性；评价FDA022-BB05在晚期实体瘤患者中的药代动力学（PK）特征；探索肿瘤组织中HER2表达水平与抗肿瘤疗效的关系。

[Translation]

To evaluate the safety and tolerability of FDA022-BB05 in patients with various advanced solid tumors; to preliminarily evaluate the anti-tumor efficacy of FDA022-BB05 in patients with various advanced solid tumors (using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); to evaluate the efficacy of FDA022-BB05 in patients with advanced solid tumors using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); to evaluate the immunogenicity of FDA022-BB05 in patients with advanced solid tumors; to evaluate the pharmacokinetic (PK) characteristics of FDA022-BB05 in patients with advanced solid tumors; and to explore the relationship between HER2 expression levels in tumor tissues and anti-tumor efficacy.

Start Date05 Jun 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT06413615

/ RecruitingPhase 2

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients with Advanced/Metastatic Solid Tumors

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.

Start Date13 May 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT05564858

/ RecruitingPhase 1

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.

Start Date16 Jan 2023

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

100 Clinical Results associated with FDA022

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100 Translational Medicine associated with FDA022

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100 Patents (Medical) associated with FDA022

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1

Literatures (Medical) associated with FDA022

14 Nov 2024·Journal of Medicinal Chemistry

Evaluation of Double Self-Immolative Linker-Based Antibody–Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential

Article

Author: Zhang, Yifan ; Cheng, Zhiyang ; Zhang, Wenbo ; Liu, Shuangxi ; Wang, Baoxia ; Wu, Yinghan ; Wu, Jingsong ; Xie, Qian ; Song, Ruiwen ; Gao, Bei ; Qiu, Xuefei ; Guo, Qingsong ; Cao, Xuemei ; Zhao, Teng ; Yin, Sicheng ; Xu, Jun ; Li, Weinan ; Yang, Tong ; Lu, Wei ; Shen, Keyu ; Wang, Lei ; Zhu, Shulei

Typical antibody-drug conjugates (ADCs) with valine-alanine linkage, often conjugated with the amino group in payloads, face challenges when interacting with hydroxyl group-containing payloads. Herein, we introduced a transformative Val-Ala-based double self-immolative linker-payload platform, reshaping ADCs by optimizing hydroxyl group-containing payload integration. Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). FDA022-BB05 demonstrated enhanced stability, effective cathepsin B sensitivity, reduced cell proliferation, increased bystander killing, and targeted delivery. Notably, acute toxicity evaluations in diverse preclinical models indicated favorable safety profiles and tolerability, with a broad therapeutic index in HER2-positive and -negative xenografts. Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials.

100 Deals associated with FDA022

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	13 May 2024
HER2 Positive Breast Cancer	Phase 1	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	16 Jan 2023
HER2-expressing Gastroesophageal Junction Adenocarcinoma	Phase 1	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	16 Jan 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05564858 (ESMO_ASIA2024) Manual	Phase 1	Solid tumor \| HER2 positive Gastrooesophageal junction cancer \| HER2 Positive Breast Cancer \| HER2-positive gastric cancer	63	FDA022-BB05	(sqaxmuhekt) = adfzkgirgn ietuukfmwi (xtdkcdfxtg ) View more	Positive	07 Dec 2024
				FDA022-BB05 (HER2-positive BC)	(pwqempsghf) = mddicgrkgl hbzifajehd (mbmwfztaux ) View more