Delving into the Latest Updates on JSKN-003 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

JSKN 003, JSKN-003, JSKN003

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 DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

HER2 Positive Breast CancerOvarian Epithelial CarcinomaRecurrent Platinum-Resistant Fallopian Tube Carcinoma+ [7]

Inactive Indication-

Originator Organization

Suzhou Alphamab Co., Ltd.

Active Organization

Jiangsu Alphamab Biopharmaceuticals Co., LtdAlphamab Australia Co. Pty Ltd.

Suzhou Alphamab Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC26H24FN3O6

InChIKeyPLXLYXLUCNZSAA-QLXKLKPCSA-N

CAS Registry1599440-33-1

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.
The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to:
Experimental group: JSKN003 monotherapy
Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Start Date01 Dec 2023

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

CTR20232959

/ RecruitingPhase 3

JSKN003对比研究者选择化疗治疗HER2低表达复发/转移性乳腺癌的随机、开放、平行对照、多中心III期临床研究

[Translation] A randomized, open, parallel-controlled, multicenter phase III clinical study of JSKN003 versus investigator-selected chemotherapy in the treatment of recurrent/metastatic breast cancer with low HER2 expression

JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的由盲态独立中心评价的无进展生存期；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的总生存期；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的由BICR评价其他疗效指标和研究者评价疗效指标；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的安全性；JSKN003对比研究者选择化疗治疗复发/转移性乳腺癌的患者报告结局；评价JSKN003的药代动力学（PK）特征、免疫原性（ADA）；评价JSKN003药品暴露水平与疗效、安全性的相关性；评价生物标志物与JSKN003疗效的相关性。

[Translation]

JSKN003 compares the progression-free survival evaluated by a blinded independent center with chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares the overall survival with chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares other efficacy indicators evaluated by BICR and efficacy indicators evaluated by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares the safety of chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares patient-reported outcomes of chemotherapy selected by the investigator for the treatment of recurrent/metastatic breast cancer; evaluate the pharmacokinetic (PK) characteristics and immunogenicity (ADA) of JSKN003; evaluate the correlation between the drug exposure level of JSKN003 and its efficacy and safety; evaluate the correlation between biomarkers and the efficacy of JSKN003.

Start Date14 Nov 2023

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

100 Clinical Results associated with JSKN-003

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100 Translational Medicine associated with JSKN-003

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100 Patents (Medical) associated with JSKN-003

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1

Literatures (Medical) associated with JSKN-003

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.

1

News (Medical) associated with JSKN-003

30 Sep 2024

·endpts.com

CSPC, Alphamab Oncology make an ADC deal; Visen’s IPO in Hong Kong

Plus, news about Sequentia Biotech: CSPC, Alphamab Oncology ink ADC deal: CSPC Pharmaceutical’s JMT-Bio Technology said it will pay RMB 400 million ($57 million) upfront and up to RMB 3.08 billion ($439 million) in total for access in China to Alphamab’s anti-HER2 bispecific ADC, called JSKN003. Visen files for IPO in Hong Kong: The six-year-old company on Monday filed to go public on the Hong Kong Stock Exchange. The Shanghai-based drug developer is working to get Ascendis’ FDA-approved pediatric growth hormone deficiency drug greenlit in China. Sequentia Biotech raises €10M: The Spanish bioinformatics company nabbed the Series A from Seventure Partners and EIC Fund.

IPODrug ApprovalADC

100 Deals associated with JSKN-003

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	05 Feb 2025
Ovarian Epithelial Carcinoma	Phase 3	-	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	15 Jan 2025
Recurrent Platinum-Resistant Fallopian Tube Carcinoma	Phase 3	-	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	15 Jan 2025
Fallopian Tube Carcinoma	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Dec 2024
Platinum-Resistant Epithelial Ovarian Carcinoma	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Dec 2024
Primary peritoneal carcinoma	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Dec 2024
HER2-Low Breast Carcinoma	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	14 Nov 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	02 Mar 2023
Metastatic Solid Tumor	Phase 1	AU	Alphamab Australia Co. Pty Ltd.	02 Sep 2022
HER2 Positive Solid Tumors	IND Approval	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	13 Nov 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05494918 \| NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	HER2 Positive Solid Tumors HER2 Positive	29	JSKN003	snpchqesfr(ngobicrbnu) = lnlrapsrsm yxaslyncrp (pnqiylwnpd ) View more	Positive	17 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	Ovarian Cancer HER2	50	JSKN003	ismheihrls(rqtfxyjvug) = iqgbyndjnn jgzkwmyeja (qvtzxkndti ) View more	Positive	17 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	27	JSKN003	cmgrodnrlg(boxemmesyq) = uztjtzuqgw rparjqihok (xnyylopedb ) View more	Positive	14 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	27	JSKN003 (HER2 IHC 1+、2+ 和 3+)	bodnvrllkh(lkyfjxtjyq) = lyulmepxzl ietccoacsh (chhuiwdrvg )	Positive	14 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	HER2 Positive Solid Tumors HER2 Positive	24	JSKN003	grwexzdlos(wnydwgnxvg) = wubynpdjgb bhpesnzvpk (rreoudzkgt ) View more	Positive	14 Sep 2024
NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	Solid tumor HER2 Expression	46	JSKN003	oyxjefekog(bmuvuaqxdb) = praxrinjjf qegqjlmrzy (bxxuimuaim, 35.8 - 66.3) View more	Positive	04 Jun 2024
NCT05744427 (JSKN003-102, ASCO2024)	Phase 1/2	Solid tumor HER2-expressing \| HER2-mutant	46	JSKN003 2.1 mg/kg	qwwyhdnbbk(bztypbgjof) = No pts experienced DLT or interstitial lung disease, and no TRAE led to death or discontinuation jewtklubgd (qkvwpcowau ) View more	Positive	24 May 2024
NCT05744427 (JSKN003-102, ASCO2024)	Phase 1/2	Solid tumor HER2-expressing \| HER2-mutant	46	JSKN003 4.2 mg/kg		Positive	24 May 2024
NCT05494918 (JSKN003-101, AACR2024) Manual	Phase 1	Solid tumor ERBB2 Mutation (Activating) \| HER2 Expression	32	JSKN003	dlxuuqtsvk(zzuiyxkxpc) = not been reached. hdusakaumf (loyxmggyxq ) View more	Positive	05 Apr 2024
NCT05494918 (JSKN003-101, Corporate Publications) Manual	Phase 1	HER2 Positive Cancer HER2 Expression	32	JSKN003	zmftygxctm(yqcgezzbfg) = nrtlhjqvmm ovmnpawsih (njvpwuayin ) View more	Positive	16 Nov 2023