Delving into the Latest Updates on Docetaxel polymeric micelle with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Docetaxel-PM, NanoxelM, 多西他赛-PM

+ [4]

Target

Tubulin

Action

modulators, inhibitors

Mechanism

Tubulin modulators, Mitosis inhibitors, Tubulin polymerisation promoters

Therapeutic Areas

NeoplasmsUrogenital DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication

Bladder CancerHead and Neck NeoplasmsAdvanced Malignant Solid Neoplasm+ [2]

Inactive Indication

Non-Muscle Invasive Bladder NeoplasmsSquamous cell carcinoma of head and neck metastatic

Originator Organization

Samyang Biopharmaceuticals Corp.

Active Organization

Samyang Biopharmaceuticals Corp.

Shandong Hubble Kisen Biological Technology Co Ltd

Shanxi Kangbao Biological Product Co. Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (01 Jul 2016),

Bladder CancerHead and Neck Neoplasms

Regulation-

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Structure/Sequence

Molecular FormulaC43H53NO14

InChIKeyZDZOTLJHXYCWBA-VCVYQWHSSA-N

CAS Registry114977-28-5

剂量递增研究（Ⅰa期）主要目的：评估注射用多西他赛聚合物胶束在晚期实体瘤患者中的安全性和耐受性；确定最大耐受剂量（MTD）和/或推荐剂量（RD）。次要目的：评估注射用多西他赛聚合物胶束在晚期实体瘤患者中的药代动力学（PK）特征；评估注射用多西他赛聚合物胶束在晚期实体瘤患者中的初步疗效。

[Translation]

Dose escalation study (Phase Ia) Primary objectives: To evaluate the safety and tolerability of docetaxel polymer micelles for injection in patients with advanced solid tumors; to determine the maximum tolerated dose (MTD) and/or recommended dose (RD). Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of docetaxel polymer micelles for injection in patients with advanced solid tumors; to evaluate the preliminary efficacy of docetaxel polymer micelles for injection in patients with advanced solid tumors.

Start Date14 Jun 2023

Sponsor / Collaborator

Shanxi Kangbao Biological Product Co. Ltd.

NCT05207514

/ TerminatedPhase 3

Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer

Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Start Date31 Mar 2022

Sponsor / Collaborator

Samyang Biopharmaceuticals Corp.

CTR20213207

/ RecruitingPhase 2

评估注射用多西他赛聚合物胶束在晚期恶性实体瘤患者中有效性和安全性的开放性、多队列II期临床研究

[Translation] An open-label, multi-cohort phase II clinical study to evaluate the efficacy and safety of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors

1. 剂量确认阶段：评估HT001三种给药方案在晚期食管癌患者中的安全性及耐受性，确定后续推荐给药方案； 2. 队列拓展阶段：评估HT001在晚期实体瘤患者中的疗效；

[Translation]

1. Dose confirmation phase: evaluate the safety and tolerability of three dosing regimens of HT001 in patients with advanced esophageal cancer and determine the subsequent recommended dosing regimen; 2. Cohort expansion phase: evaluate the efficacy of HT001 in patients with advanced solid tumors;

Start Date11 Mar 2022

Sponsor / Collaborator

Suzhou Hightechbio Biotechnology Co. Ltd.

100 Clinical Results associated with Docetaxel polymeric micelle

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100 Translational Medicine associated with Docetaxel polymeric micelle

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100 Patents (Medical) associated with Docetaxel polymeric micelle

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17,804

Literatures (Medical) associated with Docetaxel polymeric micelle

01 Jun 2025·Biomaterials

Ultrasound-triggered drug-loaded nanobubbles for enhanced T cell recruitment in cancer chemoimmunotherapy

Article

Author: Zhang, Jun ; Ling, Yi ; Guo, Yanli ; Li, Xin ; Liu, Deng ; Chen, Xuemei ; Deng, Jun ; Dong, Li ; Huang, Haiyun

Chemotherapy combined with immunotherapy is a highly promising approach for treating tumors. However, chemotherapeutic drugs often fail to accumulate effectively at the tumor site after systemic administration and they lack sufficient immunogenicity to activate adaptive immunity, making an effective T-cell immune response within the tumor microenvironment difficult to achieve. Here, this work developed drug-loaded nanobubbles (DTX-R837@NBs) that encapsulate the chemotherapy drug docetaxel and the immune adjuvant R837 via a thin-ﬁlm hydration method. Ultrasound-targeted nanobubble destruction promoted drug accumulation within tumor tissues and damaged tumor cells through the cavitation effect, inducing immunogenic cell death and releasing damage-associated molecular patterns to augment dendritic cell maturation. Notably, DTX-R837@NBs exhibited excellent contrast-enhanced ultrasound imaging capabilities, enabling the seamless integration of diagnosis and treatment. In combination with immune checkpoint blockade targeting programmed cell death protein 1 (PD-1), the generated immunological responses attacked residual tumor cells and ameliorated the immunosuppressive tumor microenvironment, inhibiting distant tumor growth and metastasis. Moreover, this strategy exhibited robust immune memory effects, effectively protecting the host and preventing tumor recurrence upon rechallenge. Overall, ultrasound-mediated DTX-R837@NBs combined with anti-PD-1 immune checkpoint blockade therapy exhibits robust antitumor efficiency, represent a promising strategy for overcoming immunotherapy resistance in cold tumors, and warrant further investigation for clinical translation.

24 Mar 2025·Journal of Biomolecular Structure and Dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Afreen, Shagufta ; Mitra, Debanjan ; Abdalla, Mohnad ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.Communicated by Ramaswamy H. Sarma.

03 Mar 2025·Oncogene

Polyploid cancer cells reveal signatures of chemotherapy resistance

Article

Author: Amend, Sarah R ; Corn, Paul ; Aparicio, Ana ; Garraway, Isla P ; Kuhn, Peter ; Hicks, James ; Schmidt, Michael J ; Amend, Sarah R. ; Prabakar, Rishvanth K. ; Pienta, Kenneth J. ; Lewis, Michael ; Prabakar, Rishvanth K ; Naghdloo, Amin ; Kamal, Mohamed ; Cadaneanu, Radu ; Schmidt, Michael J. ; Zurita-Saavedra, Amado ; Pienta, Kenneth J ; Garraway, Isla P.

AbstractTherapeutic resistance in cancer significantly contributes to mortality, with many patients eventually experiencing recurrence after initial treatment responses. Recent studies have identified therapy-resistant large polyploid cancer cells in patient tissues, particularly in late-stage prostate cancer, linking them to advanced disease and relapse. Here, we analyzed bone marrow aspirates from 44 advanced prostate cancer patients and found the presence of circulating tumor cells with increased genomic content (CTC-IGC) was significantly associated with poorer progression-free survival. Single cell copy number profiling of CTC-IGC displayed clonal origins with typical CTCs, suggesting complete polyploidization. Induced polyploid cancer cells from PC3 and MDA-MB-231 cell lines treated with docetaxel or cisplatin were examined through single cell DNA sequencing, RNA sequencing, and protein immunofluorescence. Novel RNA and protein markers, including HOMER1, TNFRSF9, and LRP1, were identified as linked to chemotherapy resistance. These markers were also present in a subset of patient CTCs and are associated with recurrence in public gene expression data. This study highlights the prognostic significance of large polyploid tumor cells, their role in chemotherapy resistance, and the expression of markers tied to cancer relapse, offering new potential avenues for therapeutic development.

100 Deals associated with Docetaxel polymeric micelle

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01CD02	DB01248

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	South Korea	Samyang Biopharmaceuticals Corp.	01 Jul 2016
Head and Neck Neoplasms	South Korea	Samyang Biopharmaceuticals Corp.	01 Jul 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	Shanxi Kangbao Biological Product Co. Ltd.	14 Jun 2023
Breast Cancer	Phase 1	South Korea	Samyang Biopharmaceuticals Corp.	31 Mar 2022
HER2-negative breast cancer	Phase 1	China	Shandong Hubble Kisen Biological Technology Co Ltd	13 May 2019
Non-Muscle Invasive Bladder Neoplasms	Phase 1	South Korea	Samyang Biopharmaceuticals Corp.	01 Jan 2017
Malignant ascites	IND Approval	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	31 May 2022
Squamous cell carcinoma of head and neck metastatic	Discovery	South Korea	Samyang Biopharmaceuticals Corp.	01 Oct 2015