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DRUG:

Enweida (envafolimab)

i
Other names: KN035, KN 035, KN-035, ASC22, ASC-22, ASC 22
Company:
3DMed, Alphamab, Ascletis, Glenmark, Simcere, Tracon Pharma
Drug class:
PD-L1 inhibitor
Related drugs:
16d
New P1/2 trial • Metastases
|
Aidixi (disitamab vedotin) • Enweida (envafolimab)
22d
New P2 trial
|
Sulanda (surufatinib) • Enweida (envafolimab)
29d
New trial • Surgery
|
Lenvima (lenvatinib) • Enweida (envafolimab)
1m
New P2 trial
|
docetaxel • Enweida (envafolimab) • Endostar (recombinant human endostatin)
2ms
β-glucan combined with Envafolimab and Endostar as immune rechallenge for metastatic non-small cell lung cancer. (PubMed, BMC Immunol)
β-glucan combined with Envafolimab and Endostar has considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients who failed of anti-PD-1 treatment previously, especially for PD-L1 positive patients.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CASP8 (Caspase 8) • ARG1 (Arginase 1) • CD40LG (CD40 ligand) • CXCL5 (Chemokine (C-X-C motif) ligand 5)
|
PD-L1 expression
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Enweida (envafolimab) • Endostar (recombinant human endostatin)
2ms
Neoadjuvant envafolimab in a patient with MSI-H/dMMR colon cancer: a case report and literature review. (PubMed, Immunotherapy)
Tumor regression was achieved after seven cycles of envafolimab treatment, and the patient obtained postoperative pathological complete response (pCR). Here, we report a case of MSI-H/dMMR transverse colon cancer, who obtained pCR after neoadjuvant envafolimab (a novel subcutaneous single-domain anti-PD-L1 antibody) with a favorable safety profile, aiming to enhance the experiences of comprehensive diagnosis and treatment of colon cancer.
Review • Journal
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Enweida (envafolimab)
3ms
KN035-BTC: Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (clinicaltrials.gov)
P3, N=480, Active, not recruiting, 3D Medicines (Sichuan) Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Jan 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
gemcitabine • oxaliplatin • Enweida (envafolimab)
3ms
KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Jun 2024 --> Dec 2024
Trial primary completion date • Metastases
|
MSI (Microsatellite instability)
|
Enweida (envafolimab)
3ms
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors (clinicaltrials.gov)
P1/2, N=170, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
sunitinib • Lenvima (lenvatinib) • Enweida (envafolimab)
3ms
Phase I Trial of Envafolimab for Healthy Male Subjects (clinicaltrials.gov)
P1, N=160, Completed, 3D Medicines (Sichuan) Co., Ltd. | Recruiting --> Completed | Trial completion date: Mar 2024 --> Nov 2023
Trial completion • Trial completion date
|
Enweida (envafolimab)
3ms
Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC. (clinicaltrials.gov)
P2, N=34, Completed, Chipscreen Biosciences, Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> May 2024
Trial completion • Trial completion date • Combination therapy • Metastases
|
Epidaza (chidamide) • Enweida (envafolimab)
3ms
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
P1, N=54, Recruiting, Kangabio AUSTRALIA LTD PTY | Not yet recruiting --> Recruiting | N=27 --> 54 | Trial completion date: Sep 2026 --> May 2026 | Trial primary completion date: Jan 2026 --> May 2026
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Enweida (envafolimab)
3ms
Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. (clinicaltrials.gov)
P2, N=45, Recruiting, Chongqing University Cancer Hospital | Not yet recruiting --> Recruiting | N=30 --> 45 | Initiation date: Oct 2023 --> Aug 2024
Enrollment open • Enrollment change • Trial initiation date • Metastases
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PD-L1 (Programmed death ligand 1)
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cisplatin • Enweida (envafolimab)
4ms
Envafolimab Inhibits the Growth of Gastric Cancer Cells with Low PD-L1 Expression through the DDX20/NF-κB/TNF-α Signaling Pathway. (PubMed, Curr Cancer Drug Targets)
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.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TNFA (Tumor Necrosis Factor-Alpha)
|
Enweida (envafolimab)
4ms
New trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
albumin-bound paclitaxel • irinotecan • Epidaza (chidamide) • Enweida (envafolimab)
4ms
New P2 trial • Combination therapy • Surgery
|
Enweida (envafolimab) • Zepsun (donafenib)
4ms
Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. (PubMed, Oncologist)
No 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.
Journal • Metastases
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MSI (Microsatellite instability)
|
oxaliplatin • irinotecan • Enweida (envafolimab)
6ms
Genetically Encoded Epoxide Warhead for Precise and Versatile Covalent Targeting of Proteins. (PubMed, J Am Chem Soc)
Our study demonstrates that EPOY, when incorporated into a nanobody (KN035), can cross-link with different side chains (mutations) at the same position of PD-L1 protein...This covalent KRAS binder holds the potential to achieve pan-covalent targeting of KRAS based on the structural similarity among all oncogenic KRAS mutants while avoiding off-target binding to NRAS/HRAS through a covalent interaction with KRAS-specific residues (H95 and E107). We envision that covalently targeting to H95 will be a promising strategy for the development of covalent pan-KRAS inhibitors in the future.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
|
Enweida (envafolimab)
6ms
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (clinicaltrials.gov)
P2, N=207, Active, not recruiting, Tracon Pharmaceuticals Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yervoy (ipilimumab) • Enweida (envafolimab)
7ms
Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer. (PubMed, Target Oncol)
Envafolimab yielded promising surgical outcomes and safety in dMMR/MSI-H locally advanced colon cancer, representing a promising treatment modality for this population.
Journal • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab)
7ms
Chidamide plus envafolimab as subsequent treatment in advanced non-small cell lung cancer patients resistant to anti-PD-1 therapy: A multicohort, open-label, phase II trial with biomarker analysis. (PubMed, Cancer Med)
Combination of chidamide and envafolimab showed efficacy signals in certain NSCLC patients. But further identification of beneficial population is necessary for precision treatment.
P2 data • Clinical Trial,Phase II • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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TMB (Tumor Mutational Burden) • HDAC2 (Histone deacetylase 2)
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PD-L1 negative • HDAC2 expression
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Epidaza (chidamide) • Enweida (envafolimab)
7ms
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=126, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | N=200 --> 126 | Trial completion date: Apr 2024 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Aug 2027
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
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Enweida (envafolimab)
8ms
ASC-ASC22-II-CTP-01: A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients (clinicaltrials.gov)
P2, N=207, Active, not recruiting, Ascletis Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jun 2023 --> Aug 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
Enweida (envafolimab)
8ms
Enrollment open • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4)
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KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • SMAD4 mutation
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Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
8ms
New P2 trial
|
BRAF (B-raf proto-oncogene)
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Erbitux (cetuximab) • irinotecan • Enweida (envafolimab)
8ms
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=86, Terminated, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.
Trial completion date • Trial termination • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • ALK positive • ROS1 positive • EGFR T790M negative
|
docetaxel • irinotecan • leucovorin calcium • Enweida (envafolimab) • suvemcitug (APX003)
8ms
New P2 trial • Metastases
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)
9ms
KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024
Trial primary completion date • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab)
10ms
KN035-CN-017: Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC (clinicaltrials.gov)
P3, N=390, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
10ms
Imaging diagnosis and efficacy monitoring by [Zr]Zr-DFO-KN035 immunoPET in patients with PD-L1-positive solid malignancies. (PubMed, Theranostics)
Moreover, after antitumor treatment, [Zr]Zr-DFO-KN035 enabled observational imaging for therapeutic efficacy evaluation, which can help predict patient prognosis. [Zr]Zr-DFO-KN035 can be used for the diagnosis and therapy monitoring of PD-L1-positive tumors and provide noninvasive and comprehensive observations for tumor diagnostic imaging, prognosis prediction, and efficacy evaluation.
Journal
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
11ms
Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma (clinicaltrials.gov)
P2, N=38, Recruiting, Liangjun Zhu M.M. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • HER-2 expression
|
oxaliplatin • Enweida (envafolimab)
11ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101
12ms
New P2 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Enweida (envafolimab)
12ms
New P2 trial
|
5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • leucovorin calcium • Enweida (envafolimab)
12ms
Journal • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab)
12ms
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=145, Suspended, LaNova Medicines Limited | Recruiting --> Suspended
Trial suspension • Combination therapy • Metastases
|
Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101
almost1year
Enrollment closed • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4)
|
KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • SMAD4 mutation
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
1year
New P3 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
1year
New P2 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
MSI-H/dMMR
|
cisplatin • Enweida (envafolimab)
1year
New P2 trial • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600
|
cisplatin • temozolomide • Enweida (envafolimab)
1year
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
paclitaxel • Lenvima (lenvatinib) • Enweida (envafolimab)
1year
Efficacy and Safety of Combining Envafolimab with Endostar in Advanced NSCLC : A Multi-Center Prospective Study (Endouble) (IASLC-WCLC 2023)
This prospective study showed that Envafolimab combined with Endostar has promising efficacy and good tolerability in advanced NSCLC with PD-L11%. This combination provided a new choice and a prospective study in furture was expected.
Clinical • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • Metastases
|
MSI (Microsatellite instability)
|
PD-L1 expression • MSI-H/dMMR • PD-L1 negative
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)