Recently, Salubris announced that JK06, a novel anti-cancer drug developed by its U.S. subsidiary Salubris Biotherapeutics, Inc., has achieved positive progress in overseas Phase I/II clinical trials. Preliminary data indicate that JK06 demonstrates favorable safety and efficacy in patients with unresectable locally advanced or metastatic tumors, including non-small cell lung cancer (NSCLC) and breast cancer[1].
The data presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting included 34 patients with advanced recurrent/refractory solid tumors enrolled in Europe (in certain countries). All patients had previously failed standard treatment regimens, with 83% having received three or more lines of therapy and 59% having received four or more lines of therapy. These patients were treated with JK06 every three weeks, covering five dose levels (1.5-8.0 mg/kg).
Of the 29 patients who underwent tumor clinical efficacy assessment, key efficacy data as follows:
● 6 patients achieved confirmed tumor shrinkage (medically termed partial response, PR), resulting in an objective response rate (ORR, the proportion of patients with significant tumor reduction) of 21%.
● Particularly outstanding efficacy was observed in the lung cancer subgroup: among 13 non-small cell lung cancer (NSCLC) patients, 5 responded, achieving an ORR of 38%, with the longest response duration maintained for 30 weeks.
● Among 7 breast cancer patients, 1 achieved confirmed partial response (PR) with a response duration of 18 weeks.
● Partial responses (PR) were achieved in the following dose groups: 3.0 mg/kg (1 NSCLC patient), 4.5 mg/kg (3 NSCLC patients and 1 breast cancer patient), and 6.0 mg/kg (1 NSCLC patient).
In terms of safety and tolerability, JK06 was generally well-tolerated. The majority of treatment-related adverse events were Grade 1 or 2, including fatigue, alopecia, decreased appetite, dry eye, and diarrhea. The overall risk profile was controllable and manageable.
JK06 is a novel targeted anti-cancer drug specifically designed to attack tumor cells expressing the 5T4 oncofetal antigen, with applications in various solid tumors including lung and breast cancers. Utilizing advanced site-specific conjugation technology, the biparatopic design enables simultaneous binding to two distinct sites on the 5T4 cancer biomarker. This "dual-insurance" mechanism generates exceptional binding strength (exhibiting picomolar-level affinity), allowing the drug to firmly adhere to targets upon encounter with minimal dissociation.
The remarkably stable binding triggers a natural cellular process—internalization of the surface drug-target complexes into the cell interior. This enables precise intracellular killing while minimizing damage to healthy cells.
Currently, JK06 is advancing through dose expansion studies to determine the recommended Phase II dose. As the program remains in early clinical development, the available data represent partial trial progress with inherent uncertainties. Further large-scale clinical trials will be required to comprehensively validate its safety and efficacy profile.
|Regarding Partial Response (PR)[2]
Partial Response (PR) refers to a state in which tumor lesions show significant shrinkage after treatment but do not completely disappear. According to the internationally recognized 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 baseline levels, with no clear progression in non-target lesions and no emergence of new lesions.
|Regarding Objective Response Rate (ORR)[3]
ORR is used to evaluate the overall antitumor efficacy of a treatment regimen. It is defined as the percentage of patients who achieve either Complete Response (CR) or Partial Response (PR) within a specified period, relative to the total treated population.
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on Overseas Clinical Trial Progress 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 (2009).
[3] K. L. Ruchalski, M. Braschi-Amirfarzan et al. "A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials." Radiology: Imaging Cancer (2021).
Disclaimer:
This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
|About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.
