Recently, Shenzhen Salubris Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") received a notification from its subsidiary, Salubris Biotherapeutics, Inc. in the United States, regarding the presentation of expansion cohort data from the Phase 1/2 trial of JK06 at the American Association for Cancer Research (AACR) Annual Meeting 2026. The data further demonstrated a favorable safety and efficacy profile of JK06 in patients with unresectable locally advanced or metastatic tumors, including non-small cell lung cancer (NSCLC) and breast cancer[1].
Expansion cohort data presented at AACR include 112 patients enrolled in Europe with advanced relapsed/refractory solid tumors who were treated with JK06 once every three weeks, including two randomized dose cohorts (3.7 mg/kg, 4.5 mg/kg) in NSCLC and breast cancer and a basket cohort consisting of multiple tumor types known to express 5T4. The data cutoff was March 29, 2026.
1. Key efficacy findings include[1]:
(1) Among 38 response-evaluable NSCLC patients, 10 attained confirmed PRs (ORR 26%), including three out of seven response-evaluable squamous cell NSCLC patients (ORR 43%), and two of three response-evaluable Epidermal Growth Factor Receptor (EGFR) mutant patients.
(2) Five out of 19 response-evaluable breast cancer patients attained PRs (ORR 26%), including four out of nine hormone receptor-positive (HR+) breast cancer patients (ORR 44%).
(3) Among other tumor types, the first and only response-evaluable gastric cancer patient enrolled attained a partial response (PR, -55%), and one of four response evaluable cervical cancer patients attained a partial response (PR, -49%).
2. Safety and tolerability:
Treatment with JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated with predominantly low grade (Grades 1 and 2) treatment-related adverse events (TRAEs) and manageable toxicities. All JK06-related AEs of any grade are below 10% frequency overall except for asthenia (11% overall). Only three total Grade 3 events have been observed to date among the 112 patients (fatigue, gait disturbance, keratitis), and no Grade 4 or 5 events have been observed. The overall safety profile was considered manageable and controllable [1].
JK06 is a biparatopic antibody-drug conjugate (ADC) that selectively targets 5T4, with intended indications for solid tumors including lung cancer and breast cancer. JK06 utilizes site-specific conjugation technology and is specifically designed to attack tumor cells expressing the 5T4 protein, making it applicable to a variety of solid tumors such as lung and breast cancers. The drug employs advanced site-specific conjugation technology; its biparatopic design means it can simultaneously bind to two sites on the cancer cell marker 5T4. This " biparatopic " design generates extremely strong binding affinity (i.e., picomolar affinity), and allows the drug to adhere firmly to its target once encountered and not easily detach.
Currently, JK06 is being evaluated in an open-label, dose-escalation and dose-expansion Phase I/II clinical study in Europe, aimed at assessing the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors known to express the 5T4 protein. The study is currently advancing through the dose-expansion phase, with next steps including the addition of a monotherapy cohort and the evaluation of JK06 in combination with various therapies.
Regarding Partial Response (PR) [2]
"Partial response (PR) refers to a state in which tumor lesions show significant shrinkage but do not completely disappear after treatment. According to the internationally adopted Response Evaluation Criteria in Solid Tumors (RECIST 1.1), PR is specifically defined as a reduction of at least 30% in the sum of diameters of all measurable target lesions compared to the baseline level, with no clear progression of non-target lesions and no appearance of new lesions."
Regarding Objective Response Rate (ORR) [3]
"It is used to measure the overall anti tumor effect of a treatment regimen. It is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) within a certain period of time out of the total treated population."
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on the Progress of Overseas Clinical Trials of JK06.
[2] E. Eisenhauer, P. Therasse et al. "New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)." European Journal of Cancer.
[3] Kathleen L. Ruchalski, Marta Braschi Amirfarzan et al. "A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials." Radiology: Imaging Cancer (2021).
Statement:
1. This material is intended to provide knowledge related to the disease area and to raise disease awareness, and is not for advertising purposes.
2. The information contained in this material is for reference purposes only. Please follow the advice or guidance of a physician or other healthcare professional.
|About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation driven pharmaceutical company integrating R&D, production, and sales, with a foothold in China and a global vision (Stock Code: 002294). With the mission of “providing outstanding pharmaceutical products for human health,” Salubris focuses on the CKM (cardiovascular kidney metabolic) chronic disease field, primarily cardiovascular diseases. The company has launched several proprietary products, including hypertension treatments Xinlitan, Fulitan®, Fulian®, and Xinchaotuo; the renal anemia treatment EnnaLuo®; and the type 2 diabetes treatment Xinliting®.
Salubris has established five innovative drug R&D centers globally and three medical device R&D bases, forming innovation platforms covering small molecule chemical drugs, biologics, siRNA and gene editing drugs, and medical devices. The company is dedicated to addressing unmet clinical needs and improving people’s quality of life.
