Delving into the Latest Updates on Becotatug with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

重组人源化抗表皮生长因子受体单克隆抗体 (津曼特生物)

+ [1]

Target

EGFR

Action

antagonists

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists)

Therapeutic Areas

NeoplasmsRespiratory DiseasesDigestive System Disorders+ [3]

Active Indication

Metastatic Non-Squamous Non-Small Cell Lung CarcinomaEGFR positive Non-squamous non-small cell lung cancerEGFR ex20ins mutation in non-small cell lung cancer+ [12]

Inactive Indication-

Originator Organization

Shanghai JMT Biological Technology Co Ltd

Active Organization

Shanghai JMT Biological Technology Co Ltd

CSPC Pharmaceutical Group Ltd.

Inactive Organization

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 756146862L

Source: *****

Sequence Code 756146864H

Source: *****

This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.

Start Date23 Oct 2024

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

CTR20243769

/ RecruitingPhase 3

JMT101联合奥希替尼对比奥希替尼一线治疗携带表皮生长因子受体（EGFR）敏感突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）的随机、对照、开放Ⅲ期临床研究

[Translation] A randomized, controlled, open-label phase III clinical study of JMT101 combined with osimertinib versus osimertinib as first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) sensitive mutations

主要目的：评价JMT101联合奥希替尼对比奥希替尼一线治疗携带EGFR敏感突变晚期NSCLC的疗效差异；次要目的：评价JMT101联合奥希替尼对比奥希替尼一线治疗携带EGFR敏感突变晚期NSCLC的疗效；评价JMT101联合奥希替尼对比奥希替尼一线治疗携带EGFR敏感突变晚期NSCLC的安全性；评价JMT101的药代动力学特征；评价JMT101的免疫原性；分析EGFR突变状态、表达水平、扩增状态与临床疗效之间的相关性；分析肿瘤相关基因改变与临床疗效之间的相关性。

[Translation]

Primary purpose: To evaluate the efficacy of JMT101 combined with osimertinib versus osimertinib as first-line treatment for advanced NSCLC with EGFR sensitive mutations; Secondary purpose: To evaluate the efficacy of JMT101 combined with osimertinib versus osimertinib as first-line treatment for advanced NSCLC with EGFR sensitive mutations; To evaluate the safety of JMT101 combined with osimertinib versus osimertinib as first-line treatment for advanced NSCLC with EGFR sensitive mutations; To evaluate the pharmacokinetic characteristics of JMT101; To evaluate the immunogenicity of JMT101; To analyze the correlation between EGFR mutation status, expression level, amplification status and clinical efficacy; To analyze the correlation between tumor-related gene changes and clinical efficacy.

Start Date17 Oct 2024

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

NCT06319313

/ Not yet recruitingPhase 2/3

A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC

This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.

Start Date01 May 2024

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

100 Clinical Results associated with Becotatug

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100 Translational Medicine associated with Becotatug

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100 Patents (Medical) associated with Becotatug

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1

Literatures (Medical) associated with Becotatug

12 Jun 2023·Nature communicationsQ1 · CROSS-FIELD

Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer.

Q1 · CROSS-FIELD

ArticleOA

Author: Luo, Feng ; Wang, Mingxia ; Huang, Yihua ; Huang, Yan ; Fang, Wenfeng ; Li, Lei ; Yang, Xiugao ; Xu, Chunwei ; Li, Mengke ; Zhao, Shen ; Zhuang, Wu ; Zhang, Junping ; Wang, Qian ; Hu, Yi ; Wu, Lin ; Hu, Longyu ; Miao, Liyun ; Zhang, Li ; Jiang, Da ; Yang, Yang ; Wang, Huijuan ; Dong, Xiaorong ; Fu, Zhenming ; Hu, Rong ; Guo, Wei ; Han, Baohui ; Song, Zhengbo

EGFR exon 20 insertion (20ins)-positive non-small-cell lung cancer (NSCLC) is an uncommon disease with limited therapeutic options and dismal prognosis. Here we report the activity, tolerability, potential mechanisms of response and resistance for dual targeting EGFR 20ins with JMT101 (anti-EGFR monoclonal antibody) plus osimertinib from preclinical models and an open label, multi-center phase 1b trial (NCT04448379). Primary endpoint of the trial is tolerability. Secondary endpoints include objective response rate, duration of response, disease control rate, progression free survival, overall survival, the pharmacokinetic profile of JMT101, occurrence of anti-drug antibodies and correlation between biomarkers and clinical outcomes. A total of 121 patients are enrolled to receive JMT101 plus osimertinib 160 mg. The most common adverse events are rash (76.9%) and diarrhea (63.6%). The confirmed objective response rate is 36.4%. Median progression-free survival is 8.2 months. Median duration of response is unreached. Subgroup analyses were performed by clinicopathological features and prior treatments. In patients with platinum-refractory diseases (n = 53), confirmed objective response rate is 34.0%, median progression-free survival is 9.2 months and median duration of response is 13.3 months. Responses are observed in distinct 20ins variants and intracranial lesions. Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%.

100 Deals associated with Becotatug

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	China	Shanghai JMT Biological Technology Co Ltd	23 Oct 2024
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	China	Shanghai JMT Biological Technology Co Ltd	17 Oct 2024
Squamous non-small cell lung cancer	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 May 2024
EGFR ex20ins mutation in non-small cell lung cancer	Phase 3	China	Shanghai JMT Biological Technology Co Ltd	28 Apr 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	26 Apr 2024
Non-small cell carcinoma	Phase 3	China	CSPC Pharmaceutical Group Ltd.	-
Metastatic Colorectal Carcinoma	Phase 2	China	Shanghai JMT Biological Technology Co Ltd	24 Nov 2023
metastatic non-small cell lung cancer	Phase 2	China	Shanghai JMT Biological Technology Co Ltd	21 Nov 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	-	Shanghai JMT Biological Technology Co Ltd	20 Nov 2021
EGFR positive non-small cell lung cancer	Phase 2	China	Shanghai JMT Biological Technology Co Ltd	17 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06391944 (BOOSTER, ESMO_ASIA2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer	161	Becotatug 6 mg/kg (Q3W) + osimertinib 80 mg (QD) (treatment naïve pts)	(lrixtcacne) = pnfhdijnrc xnwzyhirxx (wfbdemcmrh, 61.1 - 91.0) View more	Positive	12 Dec 2024
				Becotatug 6 mg/kg (Q2W) + osimertinib 80 mg (QD) (pts resistant to 1st or 2nd generation EGFR-TKI therapy and without T790M mutation)	(lrixtcacne) = lbtmurzbdy xnwzyhirxx (wfbdemcmrh, 3.2 - 37.9) View more
NCT05132777 (BECOME, ESMO_ELCC2024) Manual	Phase 2	Non-Small Cell Lung Cancer	126	Becotarug+osimertinib	(bffqgqdnwh) = xkddwmvmut sxuychkmya (hcgkirjlkf, 40 - 60) View more	Positive	20 Mar 2024
CTR20160904 (ASCO2020)	Phase 1	Colorectal Cancer	23	JMT101 monotherapy	(xmgllxclfe) = 86.0% [6/7] in combination group cizxoxhqrd (knkmclkzhh ) View more	Positive	25 May 2020
				JMT101 in combination with mFOLFOX6/FOLFIRI

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Biosimilar

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