Delving into the Latest Updates on Sotiburafusp alfa with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

anti-PD-L1 monoclonal antibody-VEGFR1 fusion protein

+ [1]

Target

PDL1 x VEGF

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors), VEGF inhibitors(Vascular endothelial growth factor inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesDigestive System Disorders

Active Indication

Advanced Endometrial CarcinomaKidney NeoplasmsAdvanced Malignant Solid Neoplasm+ [2]

Inactive Indication-

Originator Organization

Huabo Biopharm Co Ltd.

Zhejiang Huahai Pharmaceutical Co., Ltd.

Active Organization

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

Zhejiang Huahai Pharmaceutical Co., Ltd.

Fudan University

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 524448840H

Source: *****

Sequence Code 524448842L

Source: *****

Ib 期主要目的：（1）评估 HB0025 和 HB0030 联合治疗对不同类型晚期实体肿瘤患者的安全性和耐受性；（2）在不同类型的晚期实体肿瘤患者，确定 HB0025 联合 HB0030的最大耐受剂量(MTD)或剂量限制毒性(DLT)。次要目的（3）药代动力学(PK)特征；评估初步抗肿瘤活性；评估免疫原性。 II 期主要目的（1）评价 HB0025 联合 HB0030 治疗晚期非小细胞肺癌(NSCLC)、肝细胞癌(HCC)、结直肠癌(CRC)和其他类型肿瘤的抗肿瘤疗效；（2）在晚期 NSCLC、HCC、CRC 和其他类型的肿瘤中确定推荐的II 剂量(RP2D) 次要目的（3）评估抗肿瘤活性；评估安全性和耐受性;药代动力学(PK)特征；评估免疫原性。

[Translation]

Phase Ib Main objectives: (1) To evaluate the safety and tolerability of HB0025 and HB0030 combination therapy in patients with different types of advanced solid tumors; (2) To determine the maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) of HB0025 combined with HB0030 in patients with different types of advanced solid tumors. Secondary objectives (3) Pharmacokinetic (PK) characteristics; Evaluation of preliminary anti-tumor activity; Evaluation of immunogenicity. Phase II Main objectives (1) To evaluate the anti-tumor efficacy of HB0025 combined with HB0030 in the treatment of advanced non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC) and other types of tumors; (2) To determine the recommended II dose (RP2D) in advanced NSCLC, HCC, CRC and other types of tumors Secondary objectives (3) Evaluation of anti-tumor activity; Evaluation of safety and tolerability; Pharmacokinetic (PK) characteristics; Evaluation of immunogenicity.

Start Date25 Mar 2024

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

[+1]

CTR20230223 / RecruitingPhase 2

一项评价HB0025注射液在晚期子宫内膜癌受试者中安全性和有效性的多中心、开放的Ⅱ期临床研究

[Translation] A multicenter, open-label Phase II clinical study to evaluate the safety and efficacy of HB0025 injection in subjects with advanced endometrial cancer

主要目的：考察HB0025注射液在晚期子宫内膜癌患者中的抗肿瘤疗效。次要目的：考察HB0025注射液在晚期子宫内膜癌患者中的安全性；考察HB0025注射液在晚期子宫内膜癌患者的药代动力学（PK）特征；考察HB0025注射液的免疫原性。探索性目的：探讨HB0025的药物暴露量-效应关系；探索给药后外周血淋巴细胞的变化，包括CD4 + T细胞和CD8 + T细胞；根据选定的外周血生物标志物，探索HB0025的药效学（PD）效应；探讨HB0025抗肿瘤疗效与生物标志物（包括外周血及肿瘤）的关系。

[Translation]

Primary objective: To investigate the anti-tumor efficacy of HB0025 injection in patients with advanced endometrial cancer. Secondary objectives: To investigate the safety of HB0025 injection in patients with advanced endometrial cancer; To investigate the pharmacokinetic (PK) characteristics of HB0025 injection in patients with advanced endometrial cancer; To investigate the immunogenicity of HB0025 injection. Exploratory objectives: To explore the drug exposure-effect relationship of HB0025; To explore the changes in peripheral blood lymphocytes after administration, including CD4+ T cells and CD8+ T cells; To explore the pharmacodynamic (PD) effect of HB0025 based on selected peripheral blood biomarkers; To explore the relationship between the anti-tumor efficacy of HB0025 and biomarkers (including peripheral blood and tumors).

Start Date06 Sep 2023

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

[+1]

CTR20222862 / CompletedPhase 2

一项评价HB0025注射液在晚期肾癌患者中安全性和有效性的多中心、开放的II期临床研究

[Translation] A multicenter, open-label Phase II clinical study to evaluate the safety and efficacy of HB0025 injection in patients with advanced renal cancer

主要研究目的：考察HB0025注射液在晚期肾细胞癌癌患者中的抗肿瘤疗效次要目的： 1、考察HB0025注射液在晚期肾细胞癌患者中的安全性 2、考察HB0025注射液在晚期肾细胞癌患者的药代动力学（PK）特征 3、考察HB0025注射液的免疫原性探索性目的： 1、探讨HB0025的药物暴露量-效应关系； 2、探索给药后外周血淋巴细胞的变化，包括CD4 + T细胞和CD8 + T细胞 3、根据选定的外周血生物标志物，探索HB0025的药效学（PD）效应 4、探讨HB0025抗肿瘤疗效与生物标志物（包括外周血及肿瘤）的关系

[Translation]

Main research objectives: To investigate the anti-tumor efficacy of HB0025 injection in patients with advanced renal cell carcinoma Secondary objectives: 1. To investigate the safety of HB0025 injection in patients with advanced renal cell carcinoma 2. To investigate the pharmacokinetic (PK) characteristics of HB0025 injection in patients with advanced renal cell carcinoma 3. To investigate the immunogenicity of HB0025 injection Exploratory objectives: 1. To explore the drug exposure-effect relationship of HB0025; 2. To explore the changes in peripheral blood lymphocytes after administration, including CD4+ T cells and CD8+ T cells 3. To explore the pharmacodynamic (PD) effect of HB0025 based on selected peripheral blood biomarkers 4. To explore the relationship between the anti-tumor efficacy of HB0025 and biomarkers (including peripheral blood and tumors)

Start Date21 Feb 2023

Sponsor / Collaborator

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Sotiburafusp alfa

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100 Translational Medicine associated with Sotiburafusp alfa

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100 Patents (Medical) associated with Sotiburafusp alfa

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2

Literatures (Medical) associated with Sotiburafusp alfa

01 Jul 2009·Applied Radiation and IsotopesQ3 · ENGINEERING & TECHNOLOGY

Radiolabeling of monoclonal anti-vascular endothelial growth factor receptor 1 (VEGFR 1) with 177Lu for potential use in radioimmunotherapy

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Hong, Young-Don ; Felipe, Penelope M. ; Pyun, Mi-Sun ; Choi, Sun-Ju ; Lee, So-Young

The main goal of this study was to optimize the radioimmunoconjugation of monoclonal anti-vascular endothelial growth factor receptor 1 (VEGFR 1) with (177)Lu as a potential angiogenic molecular tracer for radioimmunotherapy (RIT). For a successful radiolabeling, we chose cysteine derivative DTPA-NCS as the bifunctional chelating agent and optimized radiolabeling condition with modifications on the factors such as the reaction time and molar ratio which are known to be very critical in radiolabeling. Under the optimized conditions, radiolabeling yield was greater than 99%. Immunoactivity of the radioimmunoconjugate was investigated using combinations of radioanalytical and bioanalytical techniques (ITLC-SG, Cyclone phosphorimager, and SDS-PAGE). For biological evaluations we carried out the cell binding assay and biodistribution study using mice bearing Calu6 non-small cell lung cancer xenografts. The biodistribution study showed high specificity in accumulating in tumor tissues where the tumor-to-blood ratio was 3.25:1 24h post-injection. In conclusion, the anti-VEGFR1 monoclonal antibody for angiogenesis targeting was effectively radioconjugated with (177)Lu. This radioimmunoconjugate is applicable to detect of angiogenesis sites in various diseases and treat tumors overexpressing VEGFR 1.

Frontiers in ImmunologyQ2 · MEDICINE

A Novel Bispecific Antibody Targeting PD-L1 and VEGF With Combined Anti-Tumor Activities

Q2 · MEDICINE

ArticleOA

Author: Wang, Yanting ; Cui, Xiaopei ; Yu, Haijia ; Xia, Simin ; Feng, Yujie ; Chen, Shi ; Zhu, Xiangyang ; Jia, Huifeng ; Zhan, Yifan ; Wei, Xiaoyue ; Zhang, Xuemei ; Xu, Wei ; Li, Xue ; Xin, Hong ; Zhang, Lei ; Chen, Xiaofang

Therapeutic monoclonal antibodies (mAbs) blocking immune checkpoints have been mainly used as monotherapy. Recently, combination therapy targeting multiple immune checkpoints has recently been explored to increase anti-cancer efficacy. Particularly, a single molecule targeting more than one checkpoints has been investigated. As dual blocking of PD-1/PD-L1 and VEGF/VEGFR has demonstrated synergism in anti-tumor activities, we developed a novel bispecific antibody, termed HB0025, which is formed via fusing the domain 2 of vascular endothelial growth factor receptor 1 (VEGFR1D2) and anti-PD-L1 mAb by using mAb-Trap technology. HB0025 almost completely retains the binding affinities and the biological activities in-vitro when compared with the parent anti-PD-L1 mAb or VEGFR1D2 fusion protein. Preclinical data demonstrated that HB0025 was more effective in inhibiting cancer growth than anti PD-L1 mAb or VEGFR1D2 fusion protein. Thus, our bispecific antibody may bring about greater clinical benefits and broader indications.

100 Deals associated with Sotiburafusp alfa

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	06 Sep 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	18 Jul 2023
Kidney Neoplasms	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	21 Feb 2023
Hepatocellular Carcinoma	IND Approval	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	10 Nov 2023
Neoplasms	Preclinical	CN	Zhejiang Huahai Pharmaceutical Co., Ltd.	02 Dec 2021
Neoplasms	Preclinical	CN	Fudan University	02 Dec 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06222125 (ASCO2024) Manual	Phase 1/2	Advanced Renal Cell Carcinoma PD-L1 \| VEGF \| VEGF-A ... View more	17	HB0025 10mg/kg	(ixyadptsmh) = mmowuiwmbd dmxvbmtler (lmkhixdmbj, 1.7 - 40.5) View more	Positive	24 May 2024
NCT04678908 (HB0025, ASCO2024)	Phase 1	Non-Small Cell Lung Cancer EGFR/ALK mutation \| EGFR/ALK wild-type gene	12	HB0025 3mg/kg	(dsbonhbkgp) = 33.3%, 4/12 eyjbarqrba (gixvtjzyei ) View more	Positive	24 May 2024
NCT04678908 (HB0025, ASCO2024)	Phase 1		12	HB0025 30mg/kg		Positive	24 May 2024
NCT04678908 (ASCO2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	30	HB0025	(annzfebqce) = zkwbdglyei kpzgkkwfgv (xglrdbrmna ) View more	Positive	26 May 2023