[Translation] A multicenter, randomized, double-blind, active drug-controlled Phase II clinical study to evaluate the safety and efficacy of different doses and dosing regimens of HB002.1M in patients with diabetic macular edema

1. 主要研究目的：观察和比较HB002.1M不同剂量及不同给药方案在DME患者中的安全性。 2. 次要研究目的： 1) 初步探索并比较HB002.1M不同剂量及不同给药方案在DME患者中的有效性； 2) 初步比较HB002.1M与康柏西普在DME患者中的疗效差异； 3) 探索HB002.1M多次给药的免疫原性、药代动力学及药效学特征。

[Translation]

1. Main research objectives: To observe and compare the safety of different doses and different dosing regimens of HB002.1M in patients with DME. 2. Secondary research objectives: 1) To preliminarily explore and compare the effectiveness of different doses and different dosing regimens of HB002.1M in patients with DME; 2) To preliminarily compare the efficacy differences between HB002.1M and Conbercept in patients with DME; 3) To explore the immunogenicity, pharmacokinetics and pharmacodynamic characteristics of multiple dosing of HB002.1M.

Start Date11 Oct 2021

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

CTR20200948 / RecruitingPhase 2

评价HB002.1M在湿性年龄相关性黄斑变性患者中的安全性和疗效的多中心，随机，双盲，阳性药物对照的IIa期临床研究

[Translation] A multicenter, randomized, double-blind, active-controlled Phase IIa clinical study to evaluate the safety and efficacy of HB002.1M in patients with wet age-related macular degeneration

观察和比较不同剂量 HB002.1M 在湿性AMD患者中多次给药的安全性；初步探索不同剂量的给药间隔及疗效，推荐后期临床试验的合理剂量及治疗间隔；探索HB002.1M多次给药的药代动力学研究特征。

[Translation]

Observe and compare the safety of multiple administrations of different doses of HB002.1M in patients with wet AMD; preliminarily explore the dosing intervals and efficacy of different doses, and recommend reasonable doses and treatment intervals for later clinical trials; explore the pharmacokinetic research characteristics of multiple administrations of HB002.1M.

Start Date16 Dec 2020

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

CTR20171526 / CompletedPhase 1

开放式、单次给药剂量递增的重组人VEGF受体-抗体融合蛋白注射液治疗湿性年龄相关性黄斑变性的I期临床试验

[Translation] Phase I clinical trial of an open-label, single-dose escalation recombinant human VEGF receptor-antibody fusion protein injection for the treatment of wet age-related macular degeneration

观察HB002.1M 在wet-AMD患者中单次给药的安全性；探索HB002.1M 在wet-AMD患者中的最大耐受剂量（MTD）；探索HB002.1M单次给药的药代动力学特征。

[Translation]

Observe the safety of a single dose of HB002.1M in patients with wet-AMD; Explore the maximum tolerated dose (MTD) of HB002.1M in patients with wet-AMD; Explore the pharmacokinetic characteristics of a single dose of HB002.1M.

Start Date18 May 2018

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

100 Clinical Results associated with HB002.1M

100 Translational Medicine associated with HB002.1M

100 Patents (Medical) associated with HB002.1M

Literatures (Medical) associated with HB002.1M

01 Dec 2015·BMC CancerQ2 · MEDICINE

A novel engineered VEGF blocker with an excellent pharmacokinetic profile and robust anti-tumor activity

Q2 · MEDICINE

ArticleOA

Author: Xiong, Yao ; Luo, Yan ; Tan, Hongzhi ; Huang, Xin ; Zhang, Li ; Jiang, Sumei ; Yu, Haijia ; Li, Song ; Jia, Huifeng ; Zhang, Ruliang ; Liu, Lily ; Huang, Yi ; Tian, Wenzhi ; Chu, Charles C

BACKGROUNDRelatively poor penetration and retention in tumor tissue has been documented for large molecule drugs including therapeutic antibodies and recombinant immunoglobulin constant region (Fc)-fusion proteins due to their large size, positive charge, and strong target binding affinity. Therefore, when designing a large molecular drug candidate, smaller size, neutral charge, and optimal affinity should be considered.METHODSWe engineered a recombinant protein by molecular engineering the second domain of VEGFR1 and a few flanking residues fused with the Fc fragment of human IgG1, which we named HB-002.1. This recombinant protein was extensively characterized both in vitro and in vivo for its target-binding and target-blocking activities, pharmacokinetic profile, angiogenesis inhibition activity, and anti-tumor therapeutic efficacy.RESULTSHB-002.1 has a molecular weight of ~80 kDa, isoelectric point of ~6.7, and an optimal target binding affinity of <1 nM. The pharmacokinetic profile was excellent with a half-life of 5 days, maximal concentration of 20.27 μg/ml, and area under the curve of 81.46 μg·days/ml. When tested in a transgenic zebrafish embryonic angiogenesis model, dramatic inhibition in angiogenesis was exhibited by a markedly reduced number of subintestinal vessels. When tested for anti-tumor efficacy, HB-002.1 was confirmed in two xenograft tumor models (A549 and Colo-205) to have a robust tumor killing activity, showing a percentage of inhibition over 90% at the dose of 20 mg/kg. Most promisingly, HB-002.1 showed a superior therapeutic efficacy compared to bevacizumab in the A549 xenograft model (tumor inhibition: 84.7% for HB-002.1 versus 67.6% for bevacizumab, P<0.0001).CONCLUSIONSHB-002.1 is a strong angiogenesis inhibitor that has the potential to be a novel promising drug for angiogenesis-related diseases such as tumor neoplasms and age-related macular degeneration.

100 Deals associated with HB002.1M

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	27 Apr 2022
Wet age-related macular degeneration	Phase 2	CN	Huabo Biopharm Co Ltd.	16 Dec 2020
Retinal vein occlusion-related macular edema	Discovery	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	28 Sep 2020

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