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Last update 23 Jan 2025

Envafolimab

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Nanobody

Synonyms

重组人源化PDL1单域抗体Fc融合蛋白（康宁杰瑞）

+ [3]

Target

PDL1

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [6]

Active Indication

Colorectal CancerMicrosatellite Instability-high Solid TumorsNon-Small Cell Lung Cancer+ [18]

Inactive Indication

Advanced SarcomaMalignant Fibrous HistiocytomaMetastatic Soft Tissue Sarcoma+ [4]

Originator Organization

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Active Organization

3D Medicines (Sichuan) Co., Ltd.

Suzhou Alphamab Co., Ltd.

Ascletis Pharma, Inc.

+ [5]

Inactive Organization

TRACON Pharmaceuticals, Inc.

Jiangsu Simcere Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (24 Nov 2021),

Colorectal CancerMicrosatellite Instability-high Solid Tumors

RegulationConditional marketing approval (CN), Fast Track (US), Orphan Drug (US), Breakthrough Therapy (CN), Priority Review (CN)

Structure/Sequence

Sequence Code 315610456H

Source: *****

103

Clinical Trials associated with Envafolimab

NCT04910386

/ Not yet recruitingPhase 2

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Start Date01 Jun 2025

Sponsor / Collaborator

3D Medicines (Sichuan) Co., Ltd.

NCT06772233

/ RecruitingPhase 2IIT

A Phase II, Open Controlled, Clinical Study of Regorafenib Combined with Envafolimab for Metastatic Gastrointestinal Stromal Tumors with Kit Gene Exon 17 Mutation That Failed Standard Treatment

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to previously effective maintenance regimens in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking University

NCT06692491

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking University Shenzhen Hospital

100 Clinical Results associated with Envafolimab

100 Translational Medicine associated with Envafolimab

100 Patents (Medical) associated with Envafolimab

Literatures (Medical) associated with Envafolimab

01 Nov 2024·Immunological Reviews

Single domain antibody: Development and application in biotechnology and biopharma

Review

Author: Yu, Ting ; Wen, Yurong ; He, Wenbo ; Zheng, Fang ; Muyldermans, Serge

SummaryHeavy‐chain antibodies (HCAbs) are a unique type of antibodies devoid of light chains, and comprised of two heavy chains‐only that recognize their cognate antigen by virtue of a single variable domain also referred to as VHH, single domain antibody (sdAb), or nanobody (Nb). These functional HCAbs, serendipitous discovered about three decades ago, are exclusively found in camelids, comprising dromedaries, camels, llamas, and vicugnas. Nanobodies have become an essential tool in biomedical research and medicine, both in diagnostics and therapeutics due to their beneficial properties: small size, high stability, strong antigen‐binding affinity, low immunogenicity, low production cost, and straightforward engineering into more potent affinity reagents. The occurrence of HCAbs in camelids remains intriguing. It is believed to be an evolutionary adaptation, equipping camelids with a robust adaptive immune defense suitable to respond to the pressure from a pathogenic invasion necessitating a more profound antigen recognition and neutralization. This evolutionary innovation led to a simplified HCAb structure, possibly supported by genetic mutations and drift, allowing adaptive mutation and diversification in the heavy chain variable gene and constant gene regions. Beyond understanding their origins, the application of nanobodies has significantly advanced over the past 30 years. Alongside expanding laboratory research, there has been a rapid increase in patent application for nanobodies. The introduction of commercial nanobody drugs such as Cablivi, Nanozora, Envafolimab, and Carvykti has boosted confidence among in their potential. This review explores the evolutionary history of HCAbs, their ontogeny, and applications in biotechnology and pharmaceuticals, focusing on approved and ongoing medical research pipelines.

06 Sep 2024·The Oncologist

Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors

Article

Author: Wang, Jing ; Cui, Cheng ; Xiao, Shen ; Qin, Lan ; Wang, Chunyang ; Xu, Ting ; Gong, John ; Song, Ling ; Liu, Dongyang

AbstractBackground and ObjectivesEnvafolimab is the first and only globally approved subcutaneously injectable PD-L1 antibody for the treatment of instability-high (MSI-H) or DNA mismatch repair deficient (dMMR) advanced solid tumors in adults, including those with advanced colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The aim of this investigation was to examine the pharmacokinetic and exposure-response (E-R) profile of envafolimab in patients with solid tumors to support the approval of fixed and alternative dose regimens.MethodsIn this study, a population pharmacokinetic (PopPK) modeling approach will be employed to quantitatively evaluate intrinsic and extrinsic covariates. Additionally, PopPK-estimated exposure parameters were used to evaluate E-R relationship for safety and efficacy to provide a theoretical basis for recommending optimal treatment regimens. Simulations were performed on the dosing regimens of body weight-based regimen of 2.50 mg/kg QW, fixed dose 150 mg QW, and 300 mg Q2W for the selection of alternative dosing regimens. Data from 4 clinical studies (NCT02827968, NCT03101488, NCT03248843, and NCT03667170) were utilized.ResultsThe PopPK dataset comprised 182 patients with 1810 evaluable envafolimab concentration records. Finally, a one-compartment model incorporating first-order absorption, first-order linear elimination, and time-dependent elimination according to an Emax function was found to accurately describe the concentration-time data of envafolimab in patients with advanced solid tumors. Creatinine clearance and country were identified as statistically significant factors affecting clearance, but had limited clinical significance. A relative flat exposure-response relationship was observed between early measures of safety and efficacy to verify that no dose adjustment is required. Simulation results indicated that 2.50 mg/kg QW, 150 mg QW, and 300 mg Q2W regimen yield similar steady-state exposure.ConclusionsNo statistically significant difference was observed between weight-based and fixed dose regimens. Model-based simulation supports the adoption of a 150 mg weekly or 300 mg biweekly dosing regimen of envafolimab in the solid tumor population, as these schedules effectively balance survival benefits and safety risks.

15 Jul 2024·Current Cancer Drug Targets

Envafolimab Inhibits the Growth of Gastric Cancer Cells with Low PD-L1 Expression through the DDX20/NF-κB/TNF-α Signaling Pathway

Article

Author: Ren, Jing ; Li, Feng ; Dong, Zhuanxia ; Wang, Guangyu ; Yang, Zefeng ; Wang, Yusheng

Background:The mechanism of action of envafolimab (also known as KN035), a programmed death ligand 1 (PD-L1) inhibitor, in gastric adenocarcinoma patients with low PD-L1 expression is not well understood.AIMS:This study aimed to observe the efficacy of envafolimab in gastric adenocarcinoma with low PD-L1 expression and explore the underlying mechanisms.Objective:The objective of this study was to explore the underlying mechanism of envafolimab in gastric cancer with low PD-L1 expression.Method:Cytotoxicity and proliferation were evaluated by a CCK8 assay. Transwell assays were used to detect the migration and invasion ability of gastric cancer cells. The effect of envafolimab on the apoptosis of gastric cancer cells was detected by flow cytometry. The effect of envafolimab on gastric cancer cells with low PD-L1 expression was investigated via proteomics and bioinformatics analysis.Result:A total of 19 patients with advanced gastric adenocarcinoma who received envafolimab monotherapy or combination therapy were reviewed. Among them, 4 patients had low PD-L1 expression, the objective response rate (ORR) was 75% (3/4), and the disease control rate (DCR) was 100% (4/4). In vitro experiments showed that envafolimab inhibited the proliferation, invasion, and migration of gastric cancer cells with low expression of PD-L1 and induced cell apoptosis. DDX20 may be the target of envafolimab in gastric cancer cells, and it is related to the NF-κB signaling pathway. Western blot results showed that the protein expressions of DDX20, NF-κB p65, and TNF-α in gastric cancer cells were decreased after adding envafolimab. Furthermore, the DDX20 gene was silenced by small interfering RNA to further study the effect of DDX20 on PDL1 low expression in gastric cancer cells.Conclusion:This study confirmed that envafolimab could inhibit the growth of gastric cancer cells with low PD-L1 expression by down-regulating DDX20 expression and regulating the NFκB/TNF-α signaling pathway.

109

News (Medical) associated with Envafolimab

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

31 Jul 2024

·www.fiercebiotech.com

Tracon winds down weeks after world's first injectable PD-L1 inhibitor stumbles in phase 2

Following a special meeting of its board of directors, Tracon Pharmaceuticals has terminated employees and will wind down operations. Tracon Pharmaceuticals has decided to wind down operations weeks after an injectable immune checkpoint inhibitor that was licensed from China flunked a pivotal trial in a rare cancer.The biotech gave up on envafolimab after the subcutaneous PD-L1 inhibitor only triggered responses in four out of 82 patients who had already received therapies for their undifferentiated pleomorphic sarcoma or myxofibrosarcoma. At 5%, the response rate was below the 11% the company had been aiming for.The disappointing results ended Tracon’s plans to submit envafolimab to the FDA for approval as the first injectable immune checkpoint inhibitor, despite the drug having already secured the regulatory green light in China.At the time, CEO Charles Theuer, M.D., Ph.D., said the company was moving to “immediately reduce cash burn” while seeking out strategic alternatives.It looks like those options didn’t pan out, and, this morning, the San Diego-based biotech said that following a special meeting of its board of directors, the company has terminated employees and will wind down operations. As of the end of 2023, the small biotech had 17 full-time employees, according to its annual securities filing.It’s a dramatic fall for a company that only weeks ago was eyeing the chance to cement its position with the first subcutaneous checkpoint inhibitor approved anywhere in the world. Envafolimab claimed that title in 2021 with a Chinese approval in advanced microsatellite instability-high or mismatch repair-deficient solid tumors regardless of their location in the body. The tumor-agnostic nod was based on results from a pivotal phase 2 trial conducted in China.Tracon in-licensed the North America rights to envafolimab in December 2019 through an agreement with the drug’s Chinese developers, 3D Medicines and Alphamab Oncology.

Phase 2ImmunotherapyClinical ResultDrug ApprovalLicense out/in

02 Jul 2024

·www.pharmaceutical-technology.com

Tracon mulls strategic options after sarcoma drug fails Phase II trial

Tracon licensed the North American rights to envafolimab from China-based Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in 2019. Image Credit: TarikVision / Shutterstock. TRACON Pharmaceuticals has terminated the Phase II ENVASARC trial for its sarcoma therapy, envafolimab , as the therapy is unlikely to show the level of efficacy required to support a biologics licence application (BLA). The decision to scrap the Phase II ENVASARC trial (NCT04480502) was informed by a blinded independent central review analysis that showed that the therapy’s objective response rate (ORR) is 5% in the 82 patients evaluated for the analysis. This is lower than the 11% ORR needed to meet the trial’s primary endpoint and support a BLA. Tracon has discontinued all its clinical development activities related to envafolimab and plans to reduce its cash burn. The company also plans to explore strategic alternatives, including a “merger, reverse merger, acquisition, other business combination, sales of assets, licensing or other strategic transactions”. The main asset that the company plans to leverage is its in-house product development platform. Tracon claims that the platform can offer cost and time savings while remaining independent of contract research organisations (CROs). Following the news, the company stock was down by 30.6% at market close on 1 July, compared to market close on 28 June. Tracon’s market cap now stands at $2.97m. Sarcomas are rare cancers that develop in the bones and soft tissues. Tracon investigated envafolimab as a treatment for two types of advanced or metastasised soft tissue sarcomas, undifferentiated pleomorphic sarcoma, or myxofibrosarcoma. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval Envafolimab is a programmed death ligand 1 (PD-L1) targeting single-domain antibody. Tracon licenced North American rights to the therapy from China-based Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in 2019. In 2021, envafolimab was approved in China as a treatment for advanced microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) advanced solid tumours, including advanced colorectal cancer. The therapy also received a breakthrough designation last year as a second-line treatment for non-MSI-H/non-dMMR advanced endometrial cancer, in China. Other therapies in Tracon’s pipeline include YH001, a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)-targeting antibody being developed in partnership with China-based Eucure Biopharma, and TRC102 (methoxyamine), a small molecule inhibitor of the DNA base excision repair pathway.

Phase 2Drug ApprovalBreakthrough Therapy

100 Deals associated with Envafolimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colorectal Cancer	CN	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021
Microsatellite Instability-high Solid Tumors	CN	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Nov 2023
Non-small cell lung cancer stage IIIB	Phase 3	CN	3D Medicines (Sichuan) Co., Ltd.	17 Nov 2023
Locally Advanced Rectal Carcinoma	Phase 3	CN	Sir Run Run Shaw Hospital	01 Apr 2023
Biliary Tract Neoplasms	Phase 3	CN	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	CN	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Advanced biliary tract cancer	Phase 3	-	3D Medicines (Shanghai) Co., Ltd.	-
Microsatellite instability-high colorectal cancer	Phase 2	CN	3D Medicines (Sichuan) Co., Ltd.	03 Aug 2018
Microsatellite instability-high colorectal cancer	Phase 2	CN	Suzhou Alphamab Co., Ltd.	03 Aug 2018
Mismatch repair-deficient Solid Tumors	Phase 2	CN	Suzhou Alphamab Co., Ltd.	03 Aug 2018
Mismatch repair-deficient Solid Tumors	Phase 2	CN	3D Medicines (Sichuan) Co., Ltd.	03 Aug 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05529355 (ESMO_ASIA2024) Manual	Phase 2	Non-Small Cell Lung Cancer Last line \| Second line	20	Envafolimab 150mg + Chemotherapy/Anti-VEGF	(poazfuqcgz) = ghrlwtproh wcnaqbfcxo (bbirtyuffm ) View more	Positive	07 Dec 2024
WCLC2024 Manual	Phase 2	Non-Small Cell Lung Cancer First line driver gene-negative	29	EnvafolimabRh-endostatin	(etauhbhzzc) = zsmcfoefnn htmqsbajab (hlonfojtrh, 76.8 - 109.4) View more	Positive	09 Sep 2024
NCT05243355 (WCLC2024) Manual	Phase 2	Squamous non-small cell lung cancer First line	26	Envafolimab	(ahvkmowccx) = kriahsasli phmjhbulxd (vnyhoyjylw ) View more	Positive	09 Sep 2024
NCT04480502 (ENVASARC, Biospace) Manual	Phase 2	Malignant Fibrous Histiocytoma \| myxoid MFH	82	Envafolimab	(paiscpuswp) = ncsumcbcaq gxxlrlpxap (aeyywotgsa ) Not Met	Negative	01 Jul 2024
NCT06030934 (ASCO2024) Manual	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Second line \|	16	Envafolimab + Lenvatinib + Albumin Paclitaxel	(tiofozrmtk) = wralhwaete ujqexrppqp (tstkltawua, 35.96 - 80.91) View more	Positive	24 May 2024
NCT05422183 (ENLEN-OC-001, ASCO2024) Manual	Phase 2	Platinum-Resistant Ovarian Carcinoma	12	Envafolimab plus Lenvatinib plus Etoposide	(wodfjbyhjh) = iuhxjmmvxd hjsrsuabws (rrgycwttay, 10.9 - 69.2) View more	Positive	24 May 2024
NCT05216653 (PRECAM, ASCO2024) Manual	Phase 2	Microsatellite Stable Rectal Carcinoma Neoadjuvant	32	Short-course radiotherapy + CAPEOX + Envafolimab	(eaffwhnrfz) = uyrofebwoq haucstespv (skyoztepqi ) View more	Positive	24 May 2024
NCT05112991 (ASCO2024) Manual	Phase 2	Endometrial Carcinoma \|	32	Envafolimab Lenvatinib	(hlghostanu) = csntudnjsb fpbbfvjhak (qjwjxkmbcd, 21.1 - 61.3) View more	Positive	24 May 2024
NCT05410197 (ENLIGHTEN, ASCO2024) Manual	Phase 2	Advanced Bile Duct Carcinoma First line	20	Envafolimab + Lenvatinib + Gemcitabine + Cisplatin	(alezouseek) = hshnlcqomo wunamjrgyg (lmrepsqhto ) View more	Positive	24 May 2024
NCT04480502 (ENVASARC, GlobeNewswire) Manual	Phase 2	Sarcoma	73	Envafolimab (cohort C)	(igimfnztyf) = ffvftmkuqo devxcviyxe (yvgcnnmmtb ) View more	Positive	03 Apr 2024

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