Salubris Biotherapeutics Reports Promising Phase 1/2 Data for 5T4-Targeted ADC JK06 in Multiple Solid Tumors
核心洞察
Salubris Biotherapeutics (搜索) presented Phase 1/2 expansion cohort data for JK06, a first-in-class 5T4 (搜索)-targeted antibody drug conjugate, at the AACR Annual Meeting 2026.
JK06 demonstrated notable efficacy with 26% overall response rates in both non-small cell lung cancer and breast cancer patients, including 43% response rates in squamous cell NSCLC and 44% in hormone receptor-positive breast cancer.
The treatment showed a favorable safety profile with predominantly low-grade adverse events and only three Grade 3 events observed among 112 patients in expansion cohorts.
Salubris Biotherapeutics (搜索) announced encouraging Phase 1/2 expansion cohort data for JK06, a novel 5T4 (搜索)-targeted antibody drug conjugate (ADC), demonstrating significant antitumor activity across multiple solid tumor types with a favorable safety profile. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego, California.
Clinical Efficacy Results
The expansion cohort enrolled 112 patients in Europe with advanced relapsed/refractory solid tumors who received JK06 once every three weeks. The study included two randomized dose cohorts (3.7 mg/kg and 4.5 mg/kg) in non-small cell lung cancer (NSCLC) and breast cancer, plus a basket cohort of multiple tumor types expressing 5T4 (搜索).
Non-Small Cell Lung Cancer Outcomes
Among 38 response-evaluable NSCLC patients, JK06 achieved 10 confirmed partial responses, representing an overall response rate (ORR) of 26%. Particularly notable was the activity in squamous cell NSCLC, where three of seven patients responded (ORR 43%). Additionally, two of three patients with EGFR (搜索) mutations achieved partial responses.
Breast Cancer Results
In breast cancer, five of 19 response-evaluable patients attained partial responses (ORR 26%). The treatment showed particularly strong activity in hormone receptor-positive (HR+) breast cancer, with four of nine patients responding (ORR 44%).
Activity in Other Tumor Types
JK06 demonstrated activity beyond NSCLC and breast cancer. The first gastric cancer patient enrolled achieved a partial response with a 55% tumor reduction, while one of four cervical cancer patients responded with a 49% reduction.
Safety Profile
Treatment with JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated. The safety analysis of 112 patients in expansion cohorts revealed predominantly low-grade (Grades 1 and 2) treatment-related adverse events with manageable toxicities.
All JK06-related adverse events of any grade occurred at frequencies below 10% except for asthenia, which affected 11% of patients overall. Only three Grade 3 events were observed among the 112 patients: fatigue, gait disturbance, and keratitis. No Grade 4 or 5 events were reported.
Across all 153 patients enrolled in both dose escalation and expansion phases, only seven patients required dose reductions due to treatment-related adverse events from JK06.
Drug Design and Mechanism
JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 (搜索) with a monomethyl auristatin E (MMAE) payload. The 5T4 target is an oncofetal protein overexpressed in a wide range of solid tumors, including NSCLC, breast, gastric, and genitourinary cancers. This protein is associated with more aggressive tumor progression and reduced survival.
The biparatopic design of JK06 enables picomolar affinity for 5T4 (搜索) and enhanced internalization. Combined with stable, site-specific payload conjugation, these features contribute to the drug's demonstrated efficacy and favorable safety profile.
Clinical Development Plans
"JK06 continues to demonstrate encouraging and durable efficacy among heavily pre-treated metastatic solid tumors," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics (搜索). "Partial responses have now been observed across four different cancers, including NSCLC and breast cancer, at multiple dose levels."
The company plans to advance JK06 into additional expansion cohorts, including further monotherapy cohorts and evaluation in multiple combination therapy regimens. The ongoing Phase 1/2 open-label, dose-escalation and expansion study (NCT06667960) continues to assess safety, pharmacokinetics, and preliminary efficacy.
Company Background
Salubris Biotherapeutics (搜索) is a clinical-stage biotechnology company focused on discovering and developing complex biologics for cardiovascular disease and oncology. Beyond JK06, the company is developing JK07, a potential first disease-modifying biologic for heart failure. The company is headquartered in Gaithersburg, Maryland.