Delving into the Latest Updates on HR-004 with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

Anti-CD19 anti-CD22 bispecific CAR-T cell therapy (Hrain Biotechnology), Anti-CD19 anti-CD22 bispecific chimeric antigen receptor T cell therapy(Hrain Biotechnology), Anti-human CD19-CD22 T cell therapy(Hrain Biotechnology Co. Ltd.)

+ [3]

Target

CD19 x CD22

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators), CD22 modulators(CD22 modulators), Immunologic cytotoxicity

+ [1]

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

Recurrent B Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic Leukemia

Inactive Indication

CD19 positive Acute Lymphoblastic Leukemia

Originator Organization

Hrain Biotechnology Co., Ltd.Startup

Active Organization

Hrain Biotechnology Co., Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human CD19-CD22 Targeted T Cells Injection, and to preliminarily observe the efficacy of the trial drug in patients with central nervous system involvement of refractory/relapsed B cell malignancies.

Start Date12 Aug 2022

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

[+1]

NCT05223686 / Not yet recruitingPhase 1

A Phase I Clinical Study To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for In Subjects With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.

To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells.

Start Date10 Feb 2022

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

[+1]

NCT04303520 / Unknown statusPhase 1IIT

A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.

Start Date03 May 2018

Sponsor / Collaborator

The Second Affiliated Hospital of Nanchang University

[+2]

100 Clinical Results associated with HR-004

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100 Translational Medicine associated with HR-004

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100 Patents (Medical) associated with HR-004

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1

Literatures (Medical) associated with HR-004

01 Mar 2024·Molecular and Cellular Biochemistry

Production and characterization of a camelid single domain anti-CD22 antibody conjugated to DM1

Article

Author: Davami, Fatemeh ; Behdani, Mahdi ; Ziaei, Vahab ; Habibi-Anbouhi, Mahdi ; Azarian, Bahareh ; Ghassempour, Alireza ; Dabiri, Hamed

Antibody drug conjugates (ADCs) with twelve FDA approved drugs, known as a novel category of anti-neoplastic treatment created to merge the monoclonal antibody specificity with cytotoxicity effect of chemotherapy.However, despite many undeniable advantages, ADCs face certain problems, including insufficient internalization after binding, complex structures and large size of full antibodies especially in targeting of solid tumors.Camelid single domain antibody fragments (Nanobody) offer solutions to this challenge by providing nanoscale size, high solubility and excellent stability, recombinant expression in bacteria, in vivo enhanced tissue penetration, and conjugation advantages.Here, an anti-human CD22 Nanobody was expressed in E.coli cells and conjugated to Mertansine (DM1) as a cytotoxic payload.The anti-CD22 Nanobody was expressed and purified by Ni-NTA resin.DM1 conjugated anti-CD22 Nanobody was generated by conjugation of SMCC-DM1 to Nanobody lysine groups.The conjugates were characterized using SDS-PAGE and Capillary electrophoresis (CE-SDS), RP-HPLC, and MALDI-TOF mass spectrometry.Addnl., flow cytometry anal. and a competition ELISA were carried out for binding evaluation.Finally, cytotoxicity of conjugates on Raji and Jurkat cell lines was assessed.The drug-to-antibody ratio (DAR) of conjugates was calculated 2.04 using UV spectrometry.SDS-PAGE, CE-SDS, HPLC, and mass spectrometry confirmed conjugation of DM1 to the Nanobody.The obtained results showed the anti-CD22 Nanobody cytotoxicity was enhanced almost 80% by conjugation with DM1.The binding of conjugates was similar to the non-conjugated anti-CD22 Nanobody in flow cytometry experimentsConcludingly, this study successfully suggest that the DM1 conjugated anti-CD22 Nanobody can be used as a novel tumor specific drug delivery system.

100 Deals associated with HR-004

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD19 positive Acute Lymphoblastic Leukemia	Phase 2	CN	Hrain Biotechnology Co., Ltd.Startup	03 May 2018
Recurrent B Acute Lymphoblastic Leukemia	Phase 1	CN	Hrain Biotechnology Co., Ltd.Startup	21 Jan 2022
Refractory B Acute Lymphoblastic Leukemia	Phase 1	CN	Hrain Biotechnology Co., Ltd.Startup	21 Jan 2022