[Translation] Phase Ib/IIa clinical trial to evaluate the safety, efficacy and pharmacokinetic characteristics of DS002 injection in the treatment of moderate to severe bone metastasis pain

主要目的：评估DS002注射液治疗骨转移癌痛的安全性和耐受性。次要目的：评价DS002注射液治疗中重度骨转移癌痛的初步疗效；评价DS002在患者体内的免疫原性；评价DS002在受试者体内的药代动力学（PK）特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of DS002 injection in the treatment of bone metastasis pain. Secondary objectives: To evaluate the preliminary efficacy of DS002 injection in the treatment of moderate to severe bone metastasis pain; To evaluate the immunogenicity of DS002 in patients; To evaluate the pharmacokinetic (PK) characteristics of DS002 in subjects.

Start Date28 Sep 2022

Sponsor / Collaborator

Dashi Pharmaceutical (Guangdong) Co., Ltd.

CTR20210155 / CompletedPhase 1

一项评价DS002注射液单次给药在健康受试者中的安全性、耐受性、药代动力学及免疫原性的随机、双盲、剂量递增、安慰剂对照的I期临床研究

[Translation] A randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of a single dose of DS002 injection in healthy subjects

主要目的是评价DS002在健康受试者中单次给药的安全性和耐受性，同时评价DS002在健康受试者中单次给药后的药代动力学（Pharmacokinetics, PK）特征和评价DS002在健康受试者中单次给药后的免疫原性，为后续试验推荐给药剂量。

[Translation]

The main objectives are to evaluate the safety and tolerability of a single dose of DS002 in healthy subjects, to evaluate the pharmacokinetic (PK) characteristics of DS002 after a single dose in healthy subjects, and to evaluate the immunogenicity of DS002 after a single dose in healthy subjects, so as to recommend a dosage for subsequent trials.

Start Date22 Feb 2021

Sponsor / Collaborator

Dashi Pharmaceutical (Guangdong) Co., Ltd.

100 Clinical Results associated with DS-002

100 Translational Medicine associated with DS-002

100 Patents (Medical) associated with DS-002

Literatures (Medical) associated with DS-002

01 Nov 2022·Acta Pharmacologica SinicaQ1 · MEDICINE

NGF monoclonal antibody DS002 alleviates chemotherapy-induced peripheral neuropathy in rats

Q1 · MEDICINE

Article

Author: Liu, Guo-Jian ; Tang, Lei ; Wang, Gui-Feng ; Qiu, Hong ; Wang, Qi ; Yuan, Lin ; Ding, Hua-Ping ; Xie, Zuo-Bin ; Wang, Chun-He ; Chen, Gan-Jun ; Liang, Zhi-Juan ; Tan, Jie ; Chen, Yi-Li ; Wang, Kai-Xin

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the pervasive side effects of chemotherapy, leading to poor quality of life in cancer patients. Discovery of powerful analgesics for CIPN is an urgent and substantial clinical need. Nerve growth factor (NGF), a classic neurotrophic factor, has been identified as a potential therapeutic target for pain. In this study, we generated a humanized NGF monoclonal antibody (DS002) that most effectively blocked the interaction between NGF and tropomyosin receptor kinase A (TrkA). We showed that DS002 blocked NGF binding to TrkA in a dose-dependent manner with an IC₅₀ value of 6.6 nM; DS002 dose-dependently inhibited the proliferation of TF-1 cells by blocking the TrkA-mediated downstream signaling pathway. Furthermore, DS002 did not display noticeable species differences in its binding and blocking abilities. In three chemotherapy-induced rat models of CIPN, subcutaneous injection of DS002 produced a significant prophylactic effect against paclitaxel-, cisplatin- and vincristine-induced peripheral neuropathy. In conclusion, we demonstrate for the first time that an NGF inhibitor effectively alleviates pain in animal models of CIPN. DS002 has the potential to treat CIPN pain in the clinic.

01 Jul 2011·Indian Journal of MicrobiologyQ4 · BIOLOGY

Purification and Characterization of Catechol 1,2-Dioxygenase from Acinetobacter sp. DS002 and Cloning, Sequencing of Partial catA Gene

Q4 · BIOLOGY

Article

Author: Dayananda Siddavattam ; Emmanuel Vijay Paul Pandeeti

Catechol 1,2-dioxygenase (C12O) was purified to electrophoretic homogeneity from Acinetobacter sp. DS002. The pure enzyme appears to be a homodimer with a molecular mass of 66 kDa. The apparent K(m) and V(max) for intradiol cleavage of catechol were 1.58 μM and 2 units per mg of protein respectively. Unlike other C12Os reported in the literature, the catechol 1,2-dioxygenase of Acinetobacter showed neither intradiol nor extradiol cleavage activity when substituted catechols were used as substrates. However, it has shown mild intradiol cleavage activity when benzenetriol was used as substrate. As determined by two dimensional electrophoresis (2DE) followed MALDI-TOF/TOF analyses and gel permeation chromatography, no isoforms of C12O was observed in Acinetobacter sp. DS002. Further, the C12O was seen only in cultures grown in benzoate and it was completely absent in succinate grown cultures. Based on the sequence information obtained from MS/MS data, degenerate primers were designed to amplify catA gene from the genomic DNA of Acinetobacter sp. DS002. The sequence of the PCR amplicon and deduced amino acid sequence showed 97% similarity with a catA gene of Acinetobacter baumannii AYE (YP_001713609).

Frontiers in Pharmacology

First-in-human study to assess the safety, tolerability, pharmacokinetics and immunogenicity of DS002, an anti-nerve growth factor monoclonal antibody

Article

Author: Yang, Yuanxun ; Xie, Pinhao ; Cao, Bei ; Sun, Runbin ; Huang, Lei ; Wang, Kun ; Li, Juan ; Ma, Tingting ; Lin, Hui ; Zhao, Yu ; Wang, Chunhe ; Geng, Yan

Purpose: To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of DS002 injection, an anti-nerve growth factor (anti-NGF) monoclonal antibody for treating pain conditions, in healthy Chinese subjects.Methods: This study was a single-center, randomized, double-blind, single-dose escalation, placebo-controlled design (CTR20210155). A total of 53 healthy subjects, 27 male and 26 female, were enrolled in this study, and one subject withdrew from the study before administration. Seven dose groups were set up, which were 0.5 mg, 1.0 mg, 2.0 mg, 4.0 mg, 7.0 mg, 12.0 mg and 20.0 mg, respectively. The drug was administered by single subcutaneous injection. Four subjects were enrolled in the first dose group (0.5 mg) received DS002. Other dose groups enrolled eight subjects each, six of whom received DS002 while the other two received a placebo. Safety, tolerability, pharmacokinetic parameters and immunogenicity of DS002 were assessed.Results: DS002 was well tolerated; all adverse events were Grade 1–2, and did not reach the termination standard of dose increment within the range of 0.5–20.0 mg. Adverse event rates were generally similar across treatments. After a single subcutaneous injection, the median Tmax in different dose groups ranged 167.77–337.38 h; mean t1/2 ranged 176.80–294.23 h, the volume of distribution (Vz) ranged 5265.42–7212.00 ml, and the clearance rate (CL) ranged 12.69–24.75 ml/h. In the dose range of 0.5–20.0 mg, Cmax ranged from 51.83 ± 22.74 ng/ml to 2048.86 ± 564.78 ng/ml, AUC0-t ranged from 20615.16 ± 5698.28 h·ng/mL to 1669608.11 ± 387246.36 h·ng/mL, and AUC0-inf ranged from 21852.45 ± 5920.21 h·ng/mL to 1673504.66 ± 389106.13 h·ng/mL. They all increased with dose escalation, and Cmax and AUC0-t did not have a significant dose-linear relationship, whilst AUC0-t was not dose-dependent at all. anti-drug antibody test results of each group of all subjects in this trial were negative.Conclusion: DS002 showed satisfactory safety within the dose range of 0.5 mg–20.0 mg. The absorption and metabolism of DS002 were slow, it exhibited a low volume of distribution and the clearance rate was low. These data suggest that DS002, by blocking nerve growth factor, is expected to become a novel, safe and non-addictive treatment for pain conditions.

100 Deals associated with DS-002

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 2	CN	Dashi Pharmaceutical (Guangdong) Co., Ltd.	28 Sep 2022
Neoplasms	Phase 2	CN	Dashi Pharmaceutical (Guangdong) Co., Ltd.	28 Sep 2022

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