Delving into the Latest Updates on Becotatug vedotin with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

MRG 003, MRG-003

Target

EGFR x Tubulin

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), Tubulin inhibitors

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

Nasopharyngeal CarcinomaSquamous cell carcinoma of head and neck metastaticSquamous Cell Carcinoma of Head and Neck+ [6]

Inactive Indication

Advanced biliary tract cancerAdvanced gastric carcinomaAdvanced Malignant Solid Neoplasm+ [4]

Originator Organization

Shanghai Miracogen, Inc.

Active Organization

Shanghai Miracogen, Inc.

Tot Biopharm Co. Ltd.

Lepu Biopharma Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN)

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Structure/Sequence

Sequence Code 756146862L

Source: *****

Sequence Code 756146864H

Source: *****

A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.

Start Date01 Aug 2024

Sponsor / Collaborator

West China Hospital

CTR20223356

/ RecruitingPhase 3

MRG003对比西妥昔单抗/甲氨蝶呤在二/三线治疗复发或转移性头颈鳞癌患者的随机、开放、多中心III期研究

[Translation] A randomized, open-label, multicenter phase III study of MRG003 versus cetuximab/methotrexate in the second/third-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma

本研究是一项随机、开放、多中心III期研究，在既往接受过PD-1（L1）抑制剂和铂类药物治疗失败的复发或转移性头颈鳞癌患者中，比较MRG003与西妥昔单抗/甲氨蝶呤在二/三线治疗复发或转移性头颈鳞癌患者中的疗效和安全性。

[Translation]

This study is a randomized, open-label, multicenter phase III study to compare the efficacy and safety of MRG003 with cetuximab/methotrexate in the second/third-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma who have previously failed PD-1 (L1) inhibitors and platinum-based drugs.

Start Date29 Mar 2023

Sponsor / Collaborator

Shanghai Miracogen, Inc.

NCT05751512

/ Not yet recruitingPhase 3

A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)

The objective of this study is to compare the efficacy and safety of MRG003 versus cetuximab/methotrexate as second/third line of therapy in patients with RM-SCCHN who have previously failed PD-1 (L1) inhibitors and platinum-based therapy.

Start Date01 Mar 2023

Sponsor / Collaborator

Shanghai Miracogen, Inc.

100 Clinical Results associated with Becotatug vedotin

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100 Translational Medicine associated with Becotatug vedotin

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100 Patents (Medical) associated with Becotatug vedotin

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109

Literatures (Medical) associated with Becotatug vedotin

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

14 Oct 2024·BIOMACROMOLECULES

Affibody-Functionalized Elastin-like Peptide–Drug Conjugate Nanomicelle for Targeted Ovarian Cancer Therapy

Article

Author: Li, Qingrong ; Yang, Xiaoyuan ; Yan, Deyue ; Xia, Xiao-Xia ; Xia, Xuelin

Recombinant elastin-like polypeptides (ELPs) have emerged as an attractive nanoplatform for drug delivery due to their tunable genetically encoded sequence, biocompatibility, and stimuli-responsive self-assembly behaviors. Here, we designed and biosynthesized an HER2 (human epidermal growth factor receptor 2)-targeted affibody-ELP fusion protein (Z-ELP), which was subsequently conjugated with monomethyl auristatin E (MMAE) to build a protein-drug conjugate (Z-ELP-M). Due to its thermal response, Z-ELP-M can immediately self-assemble into a nanomicelle at physiological temperature. Benefiting from its active targeting and nanomorphology, Z-ELP-M exhibits enhanced cellular internalization and deep tumor penetration in vitro. Moreover, Z-ELP-M shows excellent tumor targeting and superior antitumor efficacy in HER2-positive ovarian cancer, demonstrating a relative tumor growth inhibition of 104.6%. These findings suggest that an affibody-functionalized elastin-like peptide-drug conjugate nanomicelle is an efficient strategy to improve antitumor efficacy and biosafety in cancer therapy.

16 Sep 2024·CHEMBIOCHEM

Dual‐Targeting of the HER2 Cancer Receptor with an Antibody‐Directed Enzyme and a Nanobody‐Guided MMAE Prodrug Scaffold

Article

Author: El‐Chami, Kassem ; Smidt, Jakob Melgaard ; Märcher, Anders ; Kjems, Jørgen ; Teodori, Laura ; Omer, Marjan ; El-Chami, Kassem ; Gothelf, Kurt V ; Skaanning, Mads Koch ; Gothelf, Kurt V.

Abstract:

Antibody‐enzyme conjugates have shown potential as tissue‐specific prodrug activators by antibody‐directed enzyme prodrug therapy (ADEPT), but the approach met challenges clinically due to systemic drug release. Here, we report a novel dual‐targeting ADEPT system (DuADEPT) which is based on active cancer receptor targeting of both a trastuzumab‐sialidase conjugate (Tz‐Sia) and a highly potent sialidase‐activated monomethyl auristatin E (MMAE) prodrug scaffold. The scaffold is based on a four‐way junction of the artificial nucleic acid analog acyclic (L)‐threoninol nucleic acid ((L)‐aTNA) which at the ends of its four arms carries one nanobody targeting HER2 and three copies of the prodrug. Dual‐targeting of the constructs to two proximal epitopes of HER2 was shown by flow cytometry, and a dual‐targeted enzymatic drug release assay revealed cytotoxicity upon prodrug activation specifically for HER2‐positive cancer cells. The specific delivery and activation of prodrugs in this way could potentially be used to decrease systemic side effects and increase drug efficacy, and utilization of Tz‐Sia provides an opportunity to combine the local chemotherapeutic effect of the DuADEPT with an anticancer immune response.

1

News (Medical) associated with Becotatug vedotin

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

100 Deals associated with Becotatug vedotin

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nasopharyngeal Carcinoma	NDA/BLA	CN	Tot Biopharm Co. Ltd.	25 Sep 2024
Nasopharyngeal Carcinoma	NDA/BLA	CN	Lepu Biopharma Co., Ltd.	25 Sep 2024
Squamous cell carcinoma of head and neck metastatic	Phase 3	CN	Shanghai Miracogen, Inc.	01 Mar 2023
Squamous Cell Carcinoma of Head and Neck	Phase 3	CN	Lepu Biopharma Co., Ltd.	-
EGFR mutation Solid Tumors	Phase 2	CN	Shanghai Miracogen, Inc.	30 Jun 2022
Stomach Cancer	Phase 2	CN	Shanghai Miracogen, Inc.	18 Oct 2021
Nasopharyngeal Cancer, Recurrent	Phase 2	CN	Shanghai Miracogen, Inc.	04 Aug 2021
Advanced gastric carcinoma	Phase 2	CN	Shanghai Miracogen, Inc.	24 May 2021
Metastatic Gastric Carcinoma	Phase 2	CN	Shanghai Miracogen, Inc.	24 May 2021
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 2	CN	Shanghai Miracogen, Inc.	24 May 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05688605 (HX008/MRG003-C001, ESMO_ASIA2024) Manual	Phase 2	Nasopharyngeal Carcinoma	30	Pucotenlimab (HX008) 3.0 mg/kg + EGFR-ADC (MRG003) 2.0 mg/kg	kjnxtxobgp(foojmgmmsf) = yecxsruoec bganjgysov (ttybompdep, 59.7 - 73.7) View more	Positive	07 Dec 2024
NCT05688605 (Phase I/II study, ASCO2024) Manual	Phase 1/2	EGFR mutation Solid Tumors EGFR-positive	33	Pucotenlimab(HX008) + MRG003	gfgdleuolx(eymluwdsno) = qddycoyent cyczzstmdw (xsqpstgpis ) View more	Positive	24 May 2024
NCT04868162 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck EGFR expression	67	MRG003	syrohapsth(ziiuvssbnw) = tmymdgovjd uhnwqgeqwh (tdglicapqf )	Positive	22 Oct 2023
				MRG003 (2.3 mg/kg)	syrohapsth(ziiuvssbnw) = dqvrleyjez uhnwqgeqwh (tdglicapqf ) View more
NCT05126719 (MRG003, ESMO2023 \| NEWS) Manual	Phase 2	Nasopharyngeal Carcinoma	61	MRG003 2.0 mg/kgMRG003 2.0 mg/kg	snpwqmjyvr(fjzwupglqy) = zwfkuxcpli hncvxzuvok (lxhahshwga ) View more	Positive	21 Oct 2023
				MRG003MRG003 2.3 mg/kg	snpwqmjyvr(fjzwupglqy) = ivajckfadx hncvxzuvok (lxhahshwga ) View more
NCT05126719 (MRG003, CSCO2022)	Phase 2	Nasopharyngeal Carcinoma Last line	61	MRG003 2.0mg/kg	oxkxclfpsz(sfckzrrsmr) = xgljiiynqn wxnsbjfeqt (biowydxwhi ) View more	Positive	21 Sep 2022
				MRG003 2.3mg/kg	oxkxclfpsz(sfckzrrsmr) = wmvknxofke wxnsbjfeqt (biowydxwhi ) View more
NCT04868344 (Pubmed \| JAMA Oncol) Manual	Phase 1	Malignant Solid Neoplasm	61	MRG003 (phase 1a)	oesdzrzbbo(laiifforxi) = zfdwiqdouk xmdnibsglu (qpdsgvxbyw ) View more	Positive	05 May 2022
				MRG003 (phase 1b)	nyktzqzfzp(jofkhfscuh) = bcbyodncek pjdbcsujdo (qbdolizphz ) View more
CTR20180310 (ESMO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	22	MRG003 0.1 mg/kg	nwotgfxcrc(fumzxstxdt) = 30% kthxfskgiy (sgjvrhhzvm ) View more	-	16 Sep 2021
				MRG003 2.5 mg/kg
CTR20180310 (ASCO2020)	Phase 1	Solid tumor	22	MRG003	zbdqpfxjdh(ocpasyzlln) = daxtacgzmx qghygvhndi (eeocglewht ) View more	Positive	25 May 2020