Delving into the Latest Updates on TGI-5 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

TGI 5, TGI5

Target

CD112R

Action

antagonists

Mechanism

CD112R antagonists(Transmembrane protein PVRIG antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [1]

Active Indication

Colorectal CancerHepatocellular CarcinomaLocally Advanced Malignant Solid Neoplasm+ [4]

Inactive Indication-

Originator Organization

Hefei TG ImmunoPharma Co., Ltd

Active Organization

Hefei TG ImmunoPharma Co., Ltd

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：●确定TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的MTD/OBD。●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的安全性特征。次要目的：●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的PK特征。●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的初步抗肿瘤活性。●表征TGI 5注射液单药治疗在局部晚期/转移性实体瘤受试者中的免疫原性。探索性目的：●评价肿瘤组织中的CD155表达，并探索其与TGI-5注射液抗肿瘤活性和安全性之间的潜在关系。●探索剂量和PK暴露量与效应（包括有效性和/或安全性）之间的关系。

[Translation]

Primary objectives: ● Determine the MTD/OBD of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Evaluate the safety profile of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. Secondary objectives: ● Evaluate the PK characteristics of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Evaluate the preliminary anti-tumor activity of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Characterize the immunogenicity of TGI 5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. Exploratory objectives: ● Evaluate CD155 expression in tumor tissues and explore its potential relationship with the anti-tumor activity and safety of TGI-5 injection. ● Explore the relationship between dose and PK exposure and effect (including efficacy and/or safety).

Start Date12 Jun 2025

Sponsor / Collaborator

Hefei TG ImmunoPharma Co., Ltd

NCT07376707

/ RecruitingPhase 1

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors.
The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

Start Date12 Jun 2025

Sponsor / Collaborator

Hefei TG ImmunoPharma Co., Ltd

[+1]

100 Clinical Results associated with TGI-5

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100 Translational Medicine associated with TGI-5

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100 Patents (Medical) associated with TGI-5

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1

Literatures (Medical) associated with TGI-5

01 Jan 1989·Growth factors (Chur, Switzerland)Q4 · BIOLOGY

Monoclonal Antibodies that Specifically Inhibit GM-CSF-and IL-3-Dependent Growth of Human Monocytic Leukemia Cells

Q4 · BIOLOGY

Article

Author: G. Rovera ; M. Nagata ; G. Wong ; J. Hamuro ; K. Yoshizawa ; S. Taki ; N. Hirayama ; T. Taniyama ; T. Uchiyama

We describe monoclonal antibodies (mAbs: anti-MaG-1, TGI-1, TGI-5, and TGI-6) that block the proliferation of AML-193 cells in response to GM-CSF or IL-3 and do not affect the proliferation of AML-193 cells in response to G-CSF and IL-2-driven proliferation of Kit 225 cells. However, none of the mAbs tested had any stimulative effect on the proliferation of AML-193 cells. The mAbs (anti-MaG-1, TGI-1, -5, and -6) could inhibit the binding of [125I]GM-CSF to AML-193 cells. We were able to purify MaG-1 Ag by anti-MaG-1 affinity chromatography. Thus, the MaG-1 Ag and the Ags recognised by mAbs (TGI-1, -5, and -6) may be associated with the receptor for GM-CSF or IL-3 or a structure close to the receptor for GM-CSF or IL-3.

100 Deals associated with TGI-5

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Hepatocellular Carcinoma	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Locally Advanced Malignant Solid Neoplasm	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Melanoma, Cutaneous Malignant	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Metastatic Solid Tumor	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Non-Small Cell Lung Cancer	Phase 1	China	Hefei TG ImmunoPharma Co., Ltd	12 Jun 2025
Solid tumor	IND Approval	United States	Hefei TG ImmunoPharma Co., Ltd	30 Nov 2023

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Approval

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Biosimilar

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