Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced today that its U.S. subsidiary, Salubris Biotherapeutics, Inc., presented partial dose‑escalation data from the Phase I/II trial of the dual‑epitope antibody‑drug conjugate JK06 at the European Society for Medical Oncology (ESMO) 2025 Annual Congress.
Key Clinical Highlights
| Cohort | Tumor Type | Patients | Partial Response (PR) | ORR | Duration of Response |
|---|---|---|---|---|---|
| 3.0 mg/kg | NSCLC | 1 | 1 | 21 % | 30 wk |
| 4.5 mg/kg | NSCLC (3) + Breast (1) | 4 | 4 | 38 % | 30 wk (NSCLC) / 18 wk (Breast) |
| 6.0 mg/kg | NSCLC | 1 | 1 | 21 % | 30 wk |
- Overall ORR: 21 % across 34 patients with advanced recurrent/refractory solid tumors.
- NSCLC Sub‑group: 38 % ORR (5/13) with the longest response duration of 30 weeks.
- Breast Cancer Sub‑group: 1/7 patients achieved PR (18‑week duration).
Product Profile – JK06
- Target: 5T4 tumor‑associated antigen via a selective, dual‑epitope design.
- Payload: Monomethyl auristatin E (MMAE) delivered through site‑specific conjugation.
- Affinity: Picomolar‑level binding enables rapid target‑mediated internalization and potent cytotoxicity.
- Indications Under Investigation: Advanced solid tumors, including non‑small cell lung cancer (NSCLC) and breast cancer.
Strategic Implications
- Positive Signal for ADC Development – The 38 % ORR in NSCLC and 21 % ORR overall suggest that JK06 is a compelling candidate for further clinical development.
- Pipeline Expansion – These data reinforce Salubris’ strategy to diversify beyond traditional small‑molecule oncology agents toward advanced biologics.
- Future Plans – Salubris will next pursue a global Phase II expansion of JK06, leveraging its dual‑epitope platform and the strong clinical signal presented at ESMO.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
