In this study, we developed a dual-targeted engineered milk-derived extracellular vesicles system (7D12/KN035-iEVs), decorated with 7D12 (an EGFR nanobody) and KN035 (a PD-L1 nanobody), to specifically deliver miR-21-5p inhibitors into EGFR+ and/or PD-L1+ tumour cells and TAMs, thereby inhibiting tumour progression while reprogramming immunosuppressive TME. Notably, this dual-targeting nanomedicine synergistically inhibits tumour growth when combined with immunotherapy and radiotherapy. In summary, this mEV-based nanomedicine represents a promising universal strategy for cancer treatment, offering a versatile platform for targeting multiple components of the TME.

6 days ago

Journal

EGFR (Epidermal growth factor receptor) • MIR21 (MicroRNA 21)

PD-L1 expression

Enweida (envafolimab)

19d

PD-L1 Blockade with Biodegradable Envafolimab-Loaded Microspheres Synergizes with Transarterial Chemoembolization to Overcome Myeloid-Derived Suppressor Cell-Driven Immune Escape in Hepatocellular Carcinoma. (PubMed, ACS Appl Mater Interfaces)

These findings establish KN035-MS as a synergistic adjunct to TACE, addressing both inefficient drug delivery and postembolization immune evasion. This dual-mechanism strategy provides a clinically translatable approach to mitigate HCC recurrence, warranting further investigation in combinatorial locoregional-immunotherapy paradigms.

19 days ago

Journal

CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)

Enweida (envafolimab)

29d

Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors (clinicaltrials.gov)

P2, N=40, Not yet recruiting, Second Affiliated Hospital of Soochow University

29 days ago

New P2 trial

EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)

BRAF wild-type • EGFR positive

Erbitux (cetuximab) • Enweida (envafolimab)

Long-term survival of an advanced gastric cancer patient with multiple liver metastases following maintenance therapy with envafolimab and oral chemotherapy: a case report. (PubMed, Front Oncol)

The patient had 46 months of overall survival time with a good performance status. This case recommends that maintenance therapy comprising of both PD-L1 blockage and oral fluoropyrimidine can serve as long-duration disease control and significant long-term advantage to a subset of the patients with metastatic immune-cold gastric cancer.

1 month ago

Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • TMB (Tumor Mutational Burden)

HER-2 negative • PD-L1 negative • TMB-L

5-fluorouracil • leucovorin calcium • Enweida (envafolimab) • Tomudex (raltitrexed)

2ms

CEIL: Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=198, Recruiting, Sun Yat-sen University | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2026

2 months ago

Trial completion date • Trial primary completion date

EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)

BRAF wild-type

Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)

2ms

Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (clinicaltrials.gov)

P2, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025

2 months ago

Enrollment closed • Trial completion date • Trial primary completion date

Focus V (anlotinib) • etoposide oral • Enweida (envafolimab)

2ms

Efficacy and safety of PD-L1 blockade envafolimab as neoadjuvant treatment in mismatch repair-deficient, locally advanced colorectal cancer: An open-label, single-arm study. (PubMed, Cancer)

This preliminary study suggests that envafolimab is a promising effective and safe neoadjuvant option for locally advanced dMMR CRC; confirmation in larger cohorts is awaited.

2 months ago

Journal • Mismatch repair • dMMR

PD-L1 (Programmed death ligand 1)

MSI-H/dMMR

Enweida (envafolimab)

2ms

Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)

P2, N=26, Recruiting, Shanghai Zhongshan Hospital

2 months ago

New P2 trial

carboplatin • albumin-bound paclitaxel • Enweida (envafolimab)

2ms

Rare MSI-H hepatoid adenocarcinoma of the colon with BRAF V600E mutation achieving long-term disease-free survival after adjuvant envafolimab: a case report. (PubMed, Front Immunol)

Comprehensive molecular profiling can help guide personalized immunotherapy decisions. Further studies are needed to confirm long-term benefits, optimize treatment duration and dosing, and identify predictive biomarkers for high-risk CRC.

2 months ago

Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H

BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • PMS2 (PMS1 protein homolog 2)

BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600

Enweida (envafolimab)

2ms

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov)

P1, N=57, Recruiting, Kangabio AUSTRALIA LTD PTY

2 months ago

New P1 trial

Enweida (envafolimab)

2ms

A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread (clinicaltrials.gov)

P2, N=30, Not yet recruiting, Fudan University

2 months ago