Delving into the Latest Updates on HB002.1T with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

+ [3]

Target

TGFBR2 x VEGFR2

Mechanism

TGFBR2 inhibitors(Transforming growth factor beta receptor 2 inhibitors), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

Neoplasms

Active Indication

Advanced cancerAdvanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Huabo Biopharm Co Ltd.

Active Organization

Huabo Biopharm Co Ltd.

Zhejiang Huahai Biological Technology Co., Ltd.

Inactive Organization

Shanghai Huaaotai Biopharmaceutical Co., Ltd.

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

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主要目的:评估HB002.1T联合不同化疗方案在晚期实体瘤患者中的耐受性、安全性和药代动力学特点，确定HB002.1T联合不同化疗方案的最大耐受剂量，为II/III期临床研究推荐HB002.1T联合化疗的给药方案。次要目的:评估HB002.1T的免疫原性；按照实体瘤疗效评价标准（RECIST1.1），通过ORR、DCR、DOR和PFS初步评估HB002.1T联合不同化疗方案的抗肿瘤疗效。

[Translation]

Primary objective: To evaluate the tolerability, safety and pharmacokinetic characteristics of HB002.1T combined with different chemotherapy regimens in patients with advanced solid tumors, determine the maximum tolerated dose of HB002.1T combined with different chemotherapy regimens, and recommend the dosing regimen of HB002.1T combined with chemotherapy for Phase II/III clinical studies. Secondary objective: To evaluate the immunogenicity of HB002.1T; according to the solid tumor efficacy evaluation criteria (RECIST1.1), preliminarily evaluate the anti-tumor efficacy of HB002.1T combined with different chemotherapy regimens through ORR, DCR, DOR and PFS.

Start Date22 May 2020

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

NCT04802980 / Unknown statusPhase 1

A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors.

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.

Start Date28 Apr 2020

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

CTR20181028 / CompletedPhase 1

重组人血管内皮生长因子受体-抗体融合蛋白注射液治疗晚期实体瘤患者安全性，耐受性及药代动力学I期临床试验

[Translation] Phase I clinical trial on the safety, tolerability and pharmacokinetics of recombinant human vascular endothelial growth factor receptor-antibody fusion protein injection in the treatment of patients with advanced solid tumors

主要目的：研究 HB002.1T 在晚期实体瘤患者中的耐受性、安全性和药代动力学特点，确定剂量限制性毒性（Dose Limited Toxicity，DLT）及最大耐受剂量（Maximal Tolerated Dose，MTD），为后期临床研究推荐合理的给药方案。次要目的：评估 HB002.1T 的免疫原性；按照实体瘤疗效评价标准（RECIST 1.1），通过客观缓解率（ORR）和疾病控制率（DCR）初步评估HB002.1T 的抗肿瘤疗效。

[Translation]

Primary objective: To study the tolerability, safety and pharmacokinetic characteristics of HB002.1T in patients with advanced solid tumors, determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), and recommend a reasonable dosing regimen for later clinical studies. Secondary objective: To evaluate the immunogenicity of HB002.1T; to preliminarily evaluate the anti-tumor efficacy of HB002.1T by objective response rate (ORR) and disease control rate (DCR) according to the solid tumor efficacy evaluation criteria (RECIST 1.1).

Start Date20 Sep 2018

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

100 Clinical Results associated with HB002.1T

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100 Translational Medicine associated with HB002.1T

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100 Patents (Medical) associated with HB002.1T

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9

Literatures (Medical) associated with HB002.1T

15 Dec 1993·Biochemical JournalQ3 · BIOLOGY

Two distinct secretory ribonucleases from human cerebrum: purification, characterization and relationships to other ribonucleases

Q3 · BIOLOGY

Article

Author: Kishi, K ; Yasuda, T ; Takeshita, H ; Nadano, D

Two RNAases from human cerebrum were purified to an electrophoretically homogeneous state and their molecular masses were 22.0 kDa (tentatively called RNAase HB-1) and 19.0 kDa (RNAase HB-2). Analyses of the amino acid compositions, N-terminal amino acid sequences and catalytic properties of these enzymes provided strong evidence that they were strictly related to the secretory (sec) RNAases, such as the pancreatic enzyme, very similar immunologically to urinary sec RNAase, but clearly distinguishable from urinary non-secretory (nonsec) RNAase. There were several differences between HB-1 and HB-2, namely their immunological reactivities with specific antibodies, heat-stabilities, attached carbohydrate moieties and molecular masses. In particular, HB-2 appeared to be nonglycosylated, in view of its lack of affinity for several conjugated lectins, the absence of hexosamine and no change in electrophoretic mobility before and after peptide:N-glycosidase F digestion, whereas HB-1 and human sec RNAases purified from kidney, pancreas and urine all appeared to be glycosylated, as they moved to the same position as HB-2 when electrophoresed after glycosidase digestion. An antibody against urinary sec RNAase inhibited 75% and 20% of the total activity of the crude cerebral extract against RNA at pH 8.0 and 6.0 respectively, whereas an antibody against urinary nonsec RNAase had no such inhibitory effect. These findings suggest that yet another type(s) of cerebral RNAase, which is unable to cross-react immunologically with sec and nonsec RNAases, may exist. Two RNAases corresponding to HB-1 and HB-2 were identified in fresh cerebrospinal fluid.

01 Aug 1990·Microbial PathogenesisQ3 · MEDICINE

Induction of an immune response to the porin of Haemophilus influenzae type b by monoclonal anti-idiotypic antibodies

Q3 · MEDICINE

Article

Author: Bernard R. Brodeur ; Josée Hamel

Monoclonal anti-idiotypes were generated against monoclonal antibody (mAb) Hb-2 which recognized a highly conserved epitope on the outer membrane porin protein from Haemophilus influenzae type b (Hib). Four hybridomas reacting with F(ab') 2 fragments of Hb-2 were selected and characterized. Inhibition studies using syngeneic anti-anti-idiotypic antisera suggested that at least three different antigenic determinants on Hb-2 were recognized by these monoclonal anti-idiotypes. The binding of each anti-idiotype to Hb-2 was inhibited by Hb-2 whereas the reaction was not affected by any other anti-Hib mAb. Complete inhibition of the binding of anti-idiotype to the idiotype could be achieved with 10 micrograms of total outer membrane protein (OMP) from Hib suggesting that the anti-idiotypes might be directed against paratope-associated idiotypes. Outer membrane antigens not recognized by mAb Hb-2 did not inhibit the reaction. Furthermore, the pre-incubation of Hb-2 with each anti-idiotype specifically prevented the reaction of Hb-2 with its antigen. Antibodies with specificity for the porin were generated in guinea pigs immunized with anti-idiotypes AHb-22 and AHb-23. This study indicates that these particular monoclonal anti-idiotypes may be used as an antigen substitute for the porin of Hib in a xenogeneic species.

01 Jan 1988·Acta physiologica et pharmacologica Bulgarica

Study of the participation of the dopaminergic transmission system in the effects of two newly synthesized barbiturates.

Article

Author: Getova, D ; Markovska, V

The effects of two newly synthesized barbiturates--HB-7 (2-hydroxylamino-5-ethyl-5-sec. pentylbarbituric acid) and HB-2 (2-hydroxylamino-5-ethyl-5-propylbarbituric acid--on models of apomorphine stereotypy and haloperidol catalepsy were investigated in experiments on male rats and mice. The test drugs used were phenobarbital (PB)--in stereotypy and catalepsy, and diphenylhydantoin (DPH)--in catalepsy. HB-7 changes the stereotypy considerably: it developed faster and disappeared faster than in the control group. Phenobarbital had a weaker effect on the intensity and duration of the stereotypy. Catalepsy was induced with haloperidol in doses of 1 and 2 mg/kg. HB-7 and HB-2 weakened haloperidol catalepsy, compared with PB and DPH. The faster occurrence of apomorphine stereotypy and the weakening of the haloperidol-induced catalepsy under the effect of the two hydroxyl-amine derivatives of barbituric acid suggest an effect on the cerebral dopaminergic transmission. This effect may be mediated through the effect of HB-7 on DA-ergic transmission or through the GABA-ergic transmission in the brain structures responsible for these behavioural reactions.

100 Deals associated with HB002.1T

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	CN	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	17 Nov 2021
Advanced cancer	Phase 1	CN	Huabo Biopharm Co Ltd.	20 Sep 2018
Advanced Malignant Solid Neoplasm	Phase 1	CN	Huabo Biopharm Co Ltd.	20 Sep 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04802980 (ASCO2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	68	chemotherapy+HB002.1T	(nirlubvuau) = gzbgoobibt uyssmtrwyu (djbtliudyo ) View more	Positive	26 May 2023
				chemotherapy+HB002.1T (ovarian cancer)	(ikmigxxebu) = rzuvgskgfv nnzexbjryg (rhqsbayerh ) View more