Home Jiabao Pharma Announces Initiation of Phase I Clinical Trial for JDB153, the World’s First MNK/VEGFR Dual-Target Inhibitor

Jiabao Pharma Announces Initiation of Phase I Clinical Trial for JDB153, the World’s First MNK/VEGFR Dual-Target Inhibitor

Jun 22, 2022 10:00 CST Updated 10:00

On the afternoon of June 20, 2022, Jiabao Yaoyin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Jiabao Yaoyin”) grandly held the launch ceremony for the clinical development and Phase I clinical trial of JDB153, a globally first-in-class small-molecule inhibitor targeting both MNK and VEGFR. The study is titled “An Open-Label, Single-Center, Phase I Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JDB153 Monotherapy in Patients with Advanced Solid Tumors (Protocol Number: JDB153-01).” West China Hospital of Sichuan University serves as the sole investigational site initiating the Phase I clinical trial, with an expected enrollment of 35 to 50 patients.


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The launch ceremony was presided over by Academician Wei Yuquan. Distinguished attendees included Professor Chen Lei, Vice President of West China Hospital, Sichuan University; Professor Lu You, Director of the Department of Oncology; Professor Luo Feng, Deputy Director of the Lung Cancer Center; Professor Huang Meijuan, Deputy Director of the Department of Thoracic Oncology; Professor Wang Yongsheng, Deputy Director of the Oncology Center and Principal Investigator (PI) of the trial; Professor Zheng Li, Director of the CTC Center; Professor Feng Ping, Party Secretary of the CTC Center; Professor Wei Xiawei, Researcher at the State Key Laboratory of Biotherapy, Sichuan University; as well as other researchers involved in the project.


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Academician Wei Yuquan, on behalf of Jiabao Yaoyin, first extended his heartfelt gratitude to the hospital leadership, principal investigators, and faculty members from relevant departments who attended the launch ceremony of this clinical trial. He expressed his hope that, through the joint efforts of all parties, the project would be smoothly implemented at the West China Hospital Cancer Center and achieve complete success. He further pointed out that JDB153, as a dual-target agent against MNK and VEGFR, possesses unique innovativeness on a global scale.


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Vice President Chen Lei congratulated Jiabao Yaoyin on its Phase I clinical study of JDB153, emphasizing the hospital’s strong commitment to advancing clinical trials. She expressed her hope for collaborative efforts with Jiabao Yaoyin to jointly bring new hope to patients with solid tumors.


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Professor Wang Yongsheng, as the principal investigator of this Phase I clinical trial, provided a detailed introduction to the study protocol, including the research background, study design, inclusion and exclusion criteria, withdrawal and termination criteria, and evaluation endpoints.


Dr. Zheng Wei, Head of Clinical Development at Jiabao Yaoyin, presented an overview of the company, the development background and preclinical data of the JDB153 project, as well as subsequent development plans. He provided a detailed introduction to the preclinical efficacy and safety data of JDB153, which demonstrated significant superiority over competing drugs.


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Finally, at the launch ceremony, experts, researchers, and personnel from relevant departments involved in the clinical trials engaged in active discussions on quality assurance in clinical trials, accurate implementation of clinical protocols, clinical benefits for participants, and potential safety concerns.


Introduction to the Investigational Drug


JDB153 is the world’s first dual-target inhibitor of MNK and VEGFR. By downregulating MYC, it effectively inhibits the phosphorylation level of eukaryotic initiation factor 4E (eIF4E) and enhances T-cell activity, thereby synergizing with PD-(L)1 monoclonal antibodies. Meanwhile, it inhibits vascular endothelial growth factor receptors, suppressing tumor cell differentiation and the formation of new tumor blood vessels. In preclinical studies, JDB153 demonstrated excellent safety and tolerability, as well as superior anti-tumor activity across multiple solid tumor types. Currently, there are no highly effective treatment options for advanced solid tumors that have become refractory to PD-(L)1 therapy. JDB153 holds promise to provide patients with advanced solid tumors, such as colorectal cancer and broad-spectrum non-small cell lung cancer, with a novel, effective, and safe therapeutic option based on a new mechanism of action, carrying significant clinical value and social implications.


# Major Inclusion Criteria


(1) Patients with advanced solid tumors who have histologically or cytologically confirmed diagnoses and for whom standard therapy is unavailable, has failed, or is not tolerated;


(2) ECOG performance status of 0 or 1, and expected survival >3 months;


(3) Subjects aged >18 years;


(4) Did not participate in any other clinical trials within 28 days prior to the study.


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About Jiabao Medicine Silver


Jiabao Yaoyin was established in 2019, dedicated to medical research and clinical development of innovative drugs. Led by an academician of the Chinese Academy of Sciences and an expert in tumor biotherapy, the company is guided by clinical needs and aims to address practical clinical challenges. It focuses on developing Class I national innovative drugs that are either best-in-class or first-in-class globally and are urgently needed in clinical practice. Currently, Jiabao Yaoyin has built a core team in Chengdu and Shanghai, comprising returning overseas talents and expert professors from Fortune 500 companies, globally renowned pharmaceutical enterprises, and research institutions.


Our current key R&D pipeline includes: the drug-resistant tuberculosis medication with the highest clinical safety profile globally; a first-in-class combination therapy integrating tumor immunotherapy and anti-angiogenic agents, capable of rescuing patients who have failed PD-(L)1 inhibitor treatment; a highly selective BTK inhibitor with superior blood-brain barrier penetration; and colony-stimulating factor inhibitors validated through first-in-class PDX models. Jiabao is committed to understanding patients’ unmet needs, adopting a clinical-oriented approach to address real-world clinical challenges, and continuously deepening its expertise across multiple therapeutic areas.