Delving into the Latest Updates on Becotatug vedotin with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

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 metastaticStomach Cancer+ [6]

Inactive Indication

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

Originator Organization

Shanghai Miracogen, Inc.

Active Organization

Tot Biopharm Co. Ltd.

Shanghai Miracogen, Inc.

Lepu Biopharma Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

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

Login to view timeline

Structure/Sequence

Molecular FormulaC39H67N5O7

InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N

CAS Registry474645-27-7

View All Structures (2)

Boost your research with our ADC technology data.

login

or

view full example data

Boost your research with our ADC technology data.

Sequence Code 756146864H

Source: *****

Sequence Code 756146862L

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

Login to view more data

100 Translational Medicine associated with Becotatug vedotin

Login to view more data

100 Patents (Medical) associated with Becotatug vedotin

Login to view more data

5

Literatures (Medical) associated with Becotatug vedotin

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

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

01 Jul 2024·Cancer Treatment Reviews

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

Author: Llop, Sandra ; Braña, Irene ; O'Leary, Ben ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Jiménez-Labaig, Pablo ; Rullan, Antonio ; Bhide, Shreerang

INTRODUCTIONThere is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.METHODSWe conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).RESULTS23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.CONCLUSIONADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

01 Jul 2022·JAMA OncologyQ1 · MEDICINE

A Phase 1 Nonrandomized Clinical Trial

Q1 · MEDICINE

Article

Author: Guo, Ye ; Xi, Jingle ; Li, Hu ; Zhang, Yang ; Xu, Zhongyuan ; Wei, Xiaoli ; Qiu, Miao-Zhen ; Xue, Liqiong ; Ren, Guoxin ; Zhang, Wenxue ; Tang, Wenbo ; Liao, Wangjun ; Xu, Rui-Hua ; Wu, Yunteng ; Nian, Weiqi ; Hu, Chaohong ; Zhao, Hong-Yun ; Guo, Wei ; Wang, Ling ; Jin, Yongshuai

ImportanceThe antibody drug conjugate drug MRG003 comprises an anti-epidermal growth factor receptor (EGFR) humanized immunoglobulin G1 monoclonal antibody that is conjugated with monomethyl auristatin E via a valine-citrulline linker. There is currently insufficient evidence of this drug's safety and efficacy.ObjectiveTo evaluate the safety and maximum tolerated dose of MRG003 in a phase 1a study and investigate the preliminary antitumor activity in EGFR-expressing patients in a phase 1b study.Design, Setting, and ParticipantsThis nonrandomized open-label, single-arm, phase 1, multicenter study of solid tumors was divided into 2 parts, phase 1a dose escalation and phase 1b dose expansion. Patients with advanced or metastatic solid tumors who had failed outcomes from or were not able to receive standard treatment were enrolled in phase 1a without EGFR prescreening. Phase 1b recruited EGFR-positive patients with refractory advanced squamous cell carcinomas of the head and neck (SCCHN), nasopharyngeal carcinoma (NPC), and colorectal cancer (CRC). This study was conducted at 7 Chinese centers between April 11, 2018, and March 29, 2021 (data cutoff date). Data analysis took place between April 2021 and June 2021.InterventionsAn intravenous dose of 0.1 to 2.5 mg/kg of MRG003 was administered every 3 weeks during phase 1a. During phase 1b, patients were administered the recommended dose identified in phase 1a.Main Outcomes and MeasuresThe primary end points were dose-limiting toxic effects in phase 1a and objective response rate in phase 1b. The safety, tolerability, immunogenicity, and pharmacokinetics of MRG003 were assessed. Tumor assessment was evaluated by RECIST 1.1.ResultsTwenty-two patients (mean [range] age, 54.5 [32.0-67.0] years; 9 women [41%]) were enrolled in phase 1a and 39 patients (mean [range] age, 50.4 [27.0-75.0] years; 8 women [21%]) in phase 1b. The recommended dose was identified as 2.5 mg/kg. Eighty-nine percent of adverse events (AEs) were associated with MRG003 treatment, and most AEs were grade 1 to 2. Nineteen patients (31%) reported grade 3 or greater treatment-related AEs, including hyponatremia, leukocytopenia, neutropenia, increased aspartate aminotransferase levels, and febrile neutropenia. In phase 1a, 1 patient (5%) achieved a partial response, and 5 (23%) achieved stable disease. In phase 1b, 8 patients (21%) achieved a confirmed partial response, and 12 (31%) achieved stable disease. The objective response rates for SCCHN, NPC, and CRC were 40%, 44%, and 0%, and the disease control rates were 100%, 89%, and 25%, respectively.Conclusions and RelevanceThe findings of this nonrandomized clinical trial suggest that MRG003 showed a manageable safety profile and promising antitumor activity in patients with EGFR-positive NPC and SCCHN.Trial RegistrationClinicaltrials.gov Identifier: NCT04868344.

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

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

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
adenocarcinoma of biliary tract	Phase 2	CN	Shanghai Miracogen, Inc.	28 Apr 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Shanghai Miracogen, Inc.	23 Mar 2021
Advanced gastric carcinoma	Discovery	CN	Shanghai Miracogen, Inc.	24 May 2021
Metastatic Gastroesophageal Junction Adenocarcinoma	Discovery	CN	Shanghai Miracogen, Inc.	24 May 2021
Advanced biliary tract cancer	Discovery	CN	Shanghai Miracogen, Inc.	28 Apr 2021
EGFR positive Neoplasms	Discovery	CN	Shanghai Miracogen, Inc.	28 Apr 2021
EGFR positive non-small cell lung cancer	Discovery	CN	Shanghai Miracogen, Inc.	04 Sep 2020

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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	(zspvclpnxu) = yuzvoikkrq mmifgbhimv (ybfymbmquh, 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	(zvwywqfmuw) = cavviyfsxy pkbkwnltle (urdiuycwdt ) 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	(rrjimdkowg) = ceegefyqtc zjzzhfybva (gvjhcjqlmt )	Positive	22 Oct 2023
				MRG003 (2.3 mg/kg)	(rrjimdkowg) = fdiumreyhn zjzzhfybva (gvjhcjqlmt ) View more
NCT05126719 (MRG003, ESMO2023 \| NEWS) Manual	Phase 2	Nasopharyngeal Carcinoma	61	MRG003 2.0 mg/kgMRG003 2.0 mg/kg	(kezpsesdkn) = mafupefadw ftebowpltp (xhyuzfjxqa ) View more	Positive	21 Oct 2023
				MRG003MRG003 2.3 mg/kg	(kezpsesdkn) = syaoodnnfm ftebowpltp (xhyuzfjxqa ) View more
NCT05126719 (MRG003, CSCO2022)	Phase 2	Nasopharyngeal Carcinoma Last line	61	MRG003 2.0mg/kg	(qjuucrftps) = dxbeprnucu icidnyruyu (yyjcszwahh ) View more	Positive	21 Sep 2022
				MRG003 2.3mg/kg	(qjuucrftps) = nhbpzcmmpd icidnyruyu (yyjcszwahh ) View more
NCT04868344 (Pubmed \| JAMA Oncol) Manual	Phase 1	Malignant Solid Neoplasm	61	MRG003 (phase 1a)	(vdowinqbhn) = yjyjjvsbwj ghjdaoqcur (nuiybphodf ) View more	Positive	05 May 2022
				MRG003 (phase 1b)	(eqpexlgxrd) = ojgursvupn zymjmrtctn (remklcwler ) View more
CTR20180310 (ESMO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	22	MRG003 0.1 mg/kg	pdfwpxekaf(jmahtiqjnf) = 30% zrvgydfrfm (addevfxrdt ) View more	-	16 Sep 2021
				MRG003 2.5 mg/kg
CTR20180310 (ASCO2020)	Phase 1	Solid tumor	22	MRG003	(ubobezuyif) = rktwocqktn ryyfmqqxhv (rvudsphnkw ) View more	Positive	25 May 2020