[Translation] A single-arm, open-label, multicenter Phase II clinical study to evaluate the safety and efficacy of TB01 in patients with advanced colorectal cancer

主要目的：评价TB01在晚期结直肠癌患者中的抗肿瘤效应。次要目的： 1) 评价 TB01在晚期结直肠癌患者中的药代动力学（ PK）特征 2）评价 TB01在晚期结直肠癌患者中的安全性及耐受性。探索性目的： 1) 探索肿瘤组织中整合素的表达情况与疾病预后的相关性； 2) 探索体内细胞因子及其受体（VEGF、VEGFR）在用药前后的变化及其与疾病预后的相关性； 3) 探索TB01在晚期结肠癌患者中的免疫原性及抗药抗体（ADA）产生对PK、有效性和安全性的影响。

[Translation]

Primary purpose: To evaluate the anti-tumor effect of TB01 in patients with advanced colorectal cancer. Secondary purpose: 1) To evaluate the pharmacokinetic (PK) characteristics of TB01 in patients with advanced colorectal cancer 2) To evaluate the safety and tolerability of TB01 in patients with advanced colorectal cancer. Exploratory purpose: 1) To explore the correlation between the expression of integrins in tumor tissues and disease prognosis; 2) To explore the changes of cytokines and their receptors (VEGF, VEGFR) in the body before and after medication and their correlation with disease prognosis; 3) To explore the immunogenicity of TB01 in patients with advanced colon cancer and the effects of anti-drug antibody (ADA) production on PK, efficacy and safety.

Start Date-

Sponsor / Collaborator

Zhuhai Tengbai Pharmaceutical Co., Ltd.

CTR20200526 / RecruitingPhase 1

评估注射用HYD-PEP06在实体瘤患者中安全性、耐受性和药代动力学—一项单中心、单臂、单次及多次给药的I期临床试验

[Translation] Evaluating the safety, tolerability and pharmacokinetics of HYD-PEP06 for injection in patients with solid tumors - a single-center, single-arm, single- and multiple-dose Phase I clinical trial

主要目的：评价药物在晚期实体瘤患者中单次给药及多次给药的耐受性和安全性，确定其最大耐受剂量和剂量限制性毒性。次要目的：初步评价药物在晚期实体瘤患者中的药代动力学特征及有效性。探索性目的：初步探索药物在人体的免疫原性反应及抗药抗体产生对PK/PD、有效性和安全性的影响；初步探索药物对细胞因子EGF/VEGF的影响。

[Translation]

Primary purpose: To evaluate the tolerance and safety of single and multiple administrations of the drug in patients with advanced solid tumors, and to determine its maximum tolerated dose and dose-limiting toxicity. Secondary purpose: To preliminarily evaluate the pharmacokinetic characteristics and efficacy of the drug in patients with advanced solid tumors. Exploratory purpose: To preliminarily explore the effects of the immunogenicity of the drug in the human body and the production of anti-drug antibodies on PK/PD, efficacy and safety; to preliminarily explore the effects of the drug on cytokines EGF/VEGF.

Start Date14 Apr 2020

Sponsor / Collaborator

Harbin Medical University Pharmaceutical Co Ltd.

CTR20213196 / CompletedPhase 1

评估注射用HYD-PEP06在实体瘤患者中安全性、耐受性和药代动力学—一项单中心、单臂、单次及多次给药的I期临床试验

主要目的评价注射用HYD-PEP06在晚期实体瘤患者中单次给药及多次给药的耐受性和安全性，确定其最大耐受剂量（MTD）和剂量限制性毒性（DLT）。次要目的（1）评价注射用HYD-PEP06在晚期实体瘤患者中的药代动力学特征；（2）初步评估注射用HYD-PEP06治疗晚期实体瘤患者的有效性；探索性目的（1）初步探索注射用HYD-PEP06在人体的免疫原性反应及抗药抗体产生对PK/PD、有效性和安全性的影响；（2）初步探索注射用HYD-PEP06对细胞因子EGF/VEGF的影响。

[Translation]

Main purpose To evaluate the tolerability and safety of single and multiple doses of HYD-PEP06 for injection in patients with advanced solid tumors, and to determine its maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). Secondary purpose (1) To evaluate the pharmacokinetic characteristics of HYD-PEP06 for injection in patients with advanced solid tumors; (2) To preliminarily evaluate the efficacy of HYD-PEP06 for injection in the treatment of patients with advanced solid tumors; Exploratory purpose (1) To preliminarily explore the effects of the immunogenic response and anti-drug antibody production of HYD-PEP06 for injection in humans on PK/PD, efficacy and safety; (2) To preliminarily explore the effects of HYD-PEP06 for injection on cytokines EGF/VEGF.

Start Date03 Apr 2020

Sponsor / Collaborator

Zhuhai Tengbai Pharmaceutical Co., Ltd.

100 Clinical Results associated with HYD-PEP06

100 Translational Medicine associated with HYD-PEP06

100 Patents (Medical) associated with HYD-PEP06

Literatures (Medical) associated with HYD-PEP06

01 Jan 2024·Frontiers in pharmacology

Design, synthesis and neuroprotective activity of compound derived from Gastrodia elata Blume and borneol.

Article

Author: Shi, Baimei ; Li, Huan ; Zhi, Lijuan ; Yu, Tao ; Zhang, Hui ; Jia, Xiaoni

IntroductionTraditional Chinese medicine Gastrodia elata Blume (GEB) possesses properties that soothe the liver and dispel wind. Its constituents exhibit numerous pharmacological properties, including neuroprotective effects, analgesic properties for headache relief, memory enhancement, and others. Borneol enhances drug absorption by traversing the blood-brain barrier, thereby improving its bioavailability and therapeutic efficacy. The research aimed to design innovative drug molecules and contribute to the beneficial exploration of compound Chinese medicine modernization.MethodsThis study employed the strategy of "compound Chinese medicine molecular chemistry" to integrate and fuse the effective substances of compound Chinese medicines. An excitotoxic injury model was established by exposing PC12 cells to glutamate. Cell viability was quantitatively evaluated utilizing a colorimetric assay with the CCK-8 reagent kit. Genecards, Disgenet, and OMIM databases were used to identify potential disease-related targets. Molecular docking methods were performed to predict the binding interactions between compounds and core targets.ResultsWe designed and synthesized compounds TB-1 to TB-16. Following the evaluation of their safety, TB-1, TB-2, TB-12, and TB-16 were selected for further investigation of their neuroprotective properties. The compound designed in this study exhibits a dose-dependent protective effect on glutamate-damaged PC12 cells. Further network pharmacology and molecular docking analyses indicate that TB-2 possesses a potential therapeutic effect against cerebral ischemia, and its possible targets were SRC, MAPK1 and KDR.DiscussionThe results indicated that TB-2 displayed a significant neuroprotective effect against Glu-induced injury in PC12 cells, suggesting potential therapeutic implications for cerebral ischemia.

16 Aug 2023·Bioconjugate chemistry

Design of Highly Fluorinated Peptides for Cell-based ¹⁹F NMR.

Article

Author: Kirberger, Steven E ; Pomerantz, William C K ; Li, Jiaqian ; Wagner, Carston R ; Cui, Huarui ; Wang, Yiao

The design of imaging agents with high fluorine content is essential for overcoming the challenges associated with signal detection limits in ¹⁹F MRI-based molecular imaging. In addition to perfluorocarbon and fluorinated polymers, fluorinated peptides offer an additional strategy for creating sequence-defined ¹⁹F magnetic resonance imaging (MRI) imaging agents with a high fluorine signal. Our previously reported unstructured trifluoroacetyllysine-based peptides possessed good physiochemical properties and could be imaged at high magnetic field strength. However, the low detection limit motivated further improvements in the fluorine content of the peptides as well as removal of nonspecific cellular interactions. This research characterizes several new highly fluorinated synthetic peptides composed of highly fluorinated amino acids. ¹⁹F NMR analysis of peptides TB-1 and TB-9 led to highly overlapping, intense fluorine resonances and acceptable aqueous solubility. Flow cytometry analysis and fluorescence microscopy further showed nonspecific binding could be removed in the case of TB-9. As a preliminary experiment toward developing molecular imaging agents, a fluorinated EGFR-targeting peptide (KKK^FFKK-^βA-YHWYGYTPENVI) and an EGFR-targeting protein complex E₁-DD bioconjugated to TB-9 were prepared. Both bioconjugates maintained good ¹⁹F NMR performance in aqueous solution. While the E₁-DD-based imaging agent will require further engineering, the success of cell-based ¹⁹F NMR of the EGFR-targeting peptide in A431 cells supports the potential use of fluorinated peptides for molecular imaging.

01 Jun 2021·Acta Pharmaceutica Sinica BQ1 · CHEMISTRY

HYD-PEP06 suppresses hepatocellular carcinoma metastasis, epithelial–mesenchymal transition and cancer stem cell-like properties by inhibiting PI3K/AKT and WNT/β-catenin signaling activation

Q1 · CHEMISTRY

ArticleOA

Author: Li, Jiatong ; Han, Ying ; Wang, Zhuo ; Zhang, Tong ; Tian, Wei ; Chu, Wenfeng ; Liu, Yanyan ; Yang, Baofeng ; Liu, Yu

HYD-PEP06, an endostatin-modified polypeptide, has been shown to produce effective anti-colorectal carcinoma effects through inhibiting epithelial-mesenchymal transition (EMT). However, whether HYD-PEP06 has similar suppressive effect on hepatocellular carcinoma (HCC) remained unknown. In this study, HYD-PEP06 inhibited metastasis and EMT but not proliferation in vitro. Cignal finder pathway reporter array and Western blot analysis revealed that HYD-PEP06 suppressed HCCLM3 cell metastasis and EMT by inhibiting the PI3K/AKT pathway. Moreover, HYD-PEP06 exerted anti-metastasis effects in HepG2 cancer stem-like cells (CSCs) via suppressing the WNT/β-catenin signaling pathway. Finally, in HCCLM3 tumor-bearing BALB/c nu/nu nude mice, HYD-PEP06 substantially suppressed tumor growth, lung metastasis and HCC progress. Our results suggest that HYD-PEP06 inhibits the metastasis and EMT of HCC and CSCs as well, and thus has the potential as an agent for HCC treatment.

100 Deals associated with HYD-PEP06

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 2	CN	Zhuhai Tengbai Pharmaceutical Co., Ltd.	14 Apr 2022
Advanced Malignant Solid Neoplasm	Preclinical	CN	Zhuhai Tengbai Pharmaceutical Co., Ltd.	03 Apr 2020

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