Enweida (envafolimab)

Using this system, we engineered a covalent programmed death-ligand 1 (PD-L1) antagonistic nanobody with rapid crosslinking kinetics (kobs = 0.18 min-1, t1/2 = 3.8 min) and improved tumor suppression compared with envafolimab and atezolizumab. Similarly, we engineered a fast-acting covalent interleukin-18 (IL-18) (kobs = 0.54 min-1, t1/2 = 1.3 min) and a covalent miniprotein targeting the receptor binding domain (RBD) of SARS-CoV-2, demonstrating applicability across protein modalities.

We report two cases of advanced thymic carcinoma treated with the programmed death-ligand 1 inhibitor envafolimab with chemotherapy (liposomal paclitaxel and cisplatin)...Both patients achieved PFS (6 and 9 months, respectively) that exceeded the median PFS reported in previous clinical studies using chemotherapy alone (5 months). This combination warrants further investigation in clinical trials.

The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high-risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials.

P2, N=108, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

P3, N=390, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027

P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 --> Dec 2026

P2, N=126, Not yet recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial completion date: Jun 2027 --> Dec 2029 | Trial primary completion date: Jun 2026 --> Jun 2029

P1/2, N=170, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2025 --> Dec 2026

Tumor uptake decreased significantly after blocking with excess KN035, confirming the specificity. These results demonstrate the high PD-L1-targeting specificity of [64Cu]Cu-NOTA-KN035, suggesting its great potential as a noninvasive diagnostic tool for immunotherapy-based treatments in the future.

P2, N=30, Recruiting, Chongqing University Cancer Hospital | N=45 --> 30 | Trial completion date: Oct 2027 --> Feb 2027 | Trial primary completion date: Oct 2027 --> Feb 2027

P2, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Trial completion date: Dec 2025 --> May 2026

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.