Recently, Shenzhen Salubris Pharmaceuticals received notification from its subsidiary, Salubris Biotherapeutics, Inc., regarding updated clinical data from the Phase I/II study of JK06, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. The data further demonstrated that JK06 exhibits favorable safety and preliminary efficacy in patients with unresectable locally advanced or metastatic tumors, including non-small cell lung cancer (NSCLC) and breast cancer [1].
The latest Phase I/II clinical data on JK06, presented at the ASCO meeting, included 173 patients with advanced relapsed/refractory solid tumors enrolled across selected countries in Europe, with a data cutoff date of May 12, 2026. This patient population comprised 42 patients in the dose-escalation cohort and 131 patients in the dose-expansion cohort, which consisted of 64 patients with NSCLC, 44 patients with breast cancer, and a basket cohort of 23 patients with various tumor types known to express 5T4 antigen. All patients received JK06 once every three weeks (Q3W), and efficacy was assessed per RECIST version 1.1.
1. Key efficacy data disclosed include:
(1) Among 17 evaluable patients with squamous non-small cell lung cancer (NSCLC), the confirmed objective response rate (ORR) was 35% (6/17), reaching 50% (5/10) in the 4.5 mg/kg dose group, and the disease control rate (DCR) was 94% (16/17). Among 7 evaluable patients with epidermal growth factor receptor (EGFR) mutations, the confirmed ORR was 43% (3/7) and the DCR was 86% (6/7).
(2) Among 10 evaluable patients with hormone receptor-positive (HR+) breast cancer, the confirmed ORR was 30% (3/10) and the DCR was 60% (6/10). Among 16 evaluable patients with triple-negative breast cancer (TNBC), the confirmed ORR was 25% (4/16) and the DCR was 69% (11/16). Of the 7 responders in breast cancer, 6 had previously received antibody-drug conjugate (ADC) therapy, including 2 who had received multiple ADCs.
JK06 is a biparatopic antibody-drug conjugate (ADC) that selectively targets 5T4, intended for the treatment of solid tumors including lung and breast cancer. JK06 utilizes site-specific conjugation technology with MMAE as the payload. Its biparatopic design confers picomolar (pM)-level high affinity for 5T4, enabling target-mediated rapid internalization.
The ongoing Phase I/II open-label study of JK06 includes dose escalation (1.5 mg/kg to 8.0 mg/kg) and multiple tumor-specific expansion cohorts. The study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors known to express 5T4. As of May 12, 2026, a total of 173 patients have been enrolled. Next steps include continuing to add monotherapy cohorts and initiating evaluations of JK06 in combination with various therapies.
Regarding Objective Response Rate (ORR)[2]：
Objective response rate (ORR) refers to the proportion of patients whose tumor volume has reduced to a predefined value and maintained for a minimum required duration according to recognized response evaluation criteria (e.g., RECIST version 1.1 for solid tumors). It is the most common endpoint based on tumor measurement. Responses in solid tumors can be either Complete Response (CR) or Partial Response (PR).
References：
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on Overseas Clinical Progress of JK06.
[2] Center for Drug Evaluation, National Medical Products Administration. Guidance on Statistical Design of Clinical Trials for Antitumor Drugs (Trial Implementation) [EB/OL]. (2020-12-31)
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|About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven, research-based pharmaceutical company integrating R&D, manufacturing, and sales, with a presence in China and a global vision. The company is publicly traded on the Shenzhen Stock Exchange (stock code: 002294). Guided by its mission "to provide outstanding pharmaceutical products for human health," Salubris focuses on the CKM (Cardiovascular, Renal, Metabolism) chronic disease therapeutic area, with a primary emphasis on cardiocerebrovascular diseases. The company has launched several proprietary drugs, including Xinlitan, Fulitan®, Fulian®, and Xinchaotuo for hypertension; Ennaluo® for renal anemia; and Xinliting for type 2 diabetes.
Salubris has established five global R&D centers for innovative drugs and three R&D centers for medical devices. The company has built innovation platforms covering small molecule chemical drugs, biologics, siRNA and gene-editing therapeutics, and medical devices, striving to address unmet clinical needs and improve quality of life for patients worldwide.
