Delving into the Latest Updates on JSKN016 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

JSKN016

Target

HER3 x Trop-2

Action

modulators, inhibitors

Mechanism

HER3 modulators(Receptor tyrosine-protein kinase erbB-3 modulators), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [2]

Active Indication

Adenocarcinoma of EsophagusAdvanced Gastroesophageal Junction Adenocarcinomastomach adenocarcinoma+ [6]

Inactive Indication-

Originator Organization

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Active Organization

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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主要目的：评价JSKN016联合治疗在晚期HER2阴性乳腺癌参与者的抗肿瘤活性。次要研究目的：评价JSKN016联合治疗治疗晚期HER2阴性乳腺癌参与者的其他抗肿瘤活性、安全性和耐受性；评价JSKN016的药代动力学（PK）特征、免疫原性。探索性目的：探索肿瘤组织标本（存档或新鲜活检标本）生物标志物和临床疗效之间的相关性。

[Translation]

Primary objective: To evaluate the anti-tumor activity of JSKN016 combination therapy in participants with advanced HER2-negative breast cancer. Secondary study objectives: To evaluate other anti-tumor activities, safety and tolerability of JSKN016 combination therapy in participants with advanced HER2-negative breast cancer; to evaluate the pharmacokinetic (PK) characteristics and immunogenicity of JSKN016. Exploratory objective: To explore the correlation between biomarkers and clinical efficacy in tumor tissue specimens (archive or fresh biopsy specimens).

Start Date02 Jun 2025

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

NCT06942234

/ RecruitingPhase 1/2

The Multicenter, Open-label, Single-arm, Multi-cohort Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of JSKN016 in Combination Therapy in Chinese Participants With Inoperable Locally Advanced or Metastatic HER2-negative Breast Cancer

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.

Start Date01 Jun 2025

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

NCT06868732

/ Not yet recruitingPhase 1

Evaluation of JSKN016 Combination Therapy in Subjects with Advanced Non-Small Cell Lung Cancer: a Phase Ib Study

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Start Date12 Mar 2025

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

100 Clinical Results associated with JSKN016

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100 Translational Medicine associated with JSKN016

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100 Patents (Medical) associated with JSKN016

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1

Literatures (Medical) associated with JSKN016

RSC Medicinal Chemistry

Technical, preclinical, and clinical developments of Fc-glycan-specific antibody–drug conjugates

Review

Author: Liu, Yunpeng ; Yang, Qiang

Fc-glycan-specific ADC is a significant advance in site-specific ADCs for cancer therapy. Notably, JSKN003 and IBI343 have demonstrated promising results in phase 1 clinical trials and are advancing into phase 3 studies.

100 Deals associated with JSKN016

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2-negative breast cancer	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	01 Jun 2025
Metastatic HER2-Negative Breast Carcinoma	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	01 Jun 2025
Adenocarcinoma of Esophagus	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	25 Apr 2025
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	25 Apr 2025
stomach adenocarcinoma	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	25 Apr 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 2	-	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	17 Jan 2025
Extensive stage Small Cell Lung Cancer	Phase 2	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	13 Jan 2025
Advanced Malignant Solid Neoplasm	Phase 1	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	30 Apr 2024
Advanced breast cancer	IND Approval	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	20 Mar 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06592417 (JSKN016-101, ASCO2025)	Phase 1	Metastatic Triple-Negative Breast Carcinoma TROP2 \| HER3	19	JSKN016 4 mg/kg Q3W	bksewrzbpz(zxjnocoatw) = Manageable hemotoxicity was observed with ≥ G3 events only occurred in 2 (10.5%) pts, including 1 G3 neutropenia and 1 G3 lymphopenia vnuhicesgg (ufarghfgfk ) View more	Positive	30 May 2025

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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