Delving into the Latest Updates on HLX-35 with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Target

4-1BB x EGFR

Action

agonists, modulators

Mechanism

4-1BB agonists(Tumor necrosis factor receptor superfamily member 9 agonists), EGFR modulators(Epidermal growth factor receptor erbB1 modulators)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Solid tumorMetastatic Solid TumorSquamous non-small cell lung cancer+ [3]

Inactive Indication-

Originator Organization

Shanghai Henlius Biopharmaceuticals Co. , Ltd.

Active Organization

Shanghai Henlius Biotech, Inc.Binacea Pharma, Inc.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 (Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody Injection) in Combination With HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors.

Start Date06 Jan 2023

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT05360381

/ Active, not recruitingPhase 1

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX35 (Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.

Start Date03 Jun 2022

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

CTR20220678

/ RecruitingPhase 1

一项评估HLX35（重组人源抗EGFR与抗4-1BB双特异性抗体）在晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学特征及初步疗效的Ⅰ期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX35 (recombinant human anti-EGFR and anti-4-1BB bispecific antibody) in patients with advanced or metastatic solid tumors

主要研究目的：在没有或无法接受标准治疗的晚期或转移性肿瘤患者中确定HLX35的安全性、剂量限制性毒性（DLT）、最大耐受剂量（MTD）及推荐 2 期剂量（RP2D）；次要研究目的：研究 HLX35 的药代动力学（PK）特征、研究 HLX35 的药效学（PD）特征、研究 HLX35 的免疫原性、初步研究HLX35的抗肿瘤活性；探索性目的：探索与HLX35抗肿瘤活性相关的生物标志物、探索血清细胞因子的释放。

[Translation]

The main study objectives are to determine the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of HLX35 in patients with advanced or metastatic tumors who have not or cannot receive standard treatment; secondary study objectives are to study the pharmacokinetic (PK) characteristics of HLX35, the pharmacodynamic (PD) characteristics of HLX35, the immunogenicity of HLX35, and the preliminarily study the anti-tumor activity of HLX35; exploratory objectives are to explore biomarkers associated with the anti-tumor activity of HLX35 and explore the release of serum cytokines.

Start Date02 Jun 2022

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

[+1]

100 Clinical Results associated with HLX-35

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100 Translational Medicine associated with HLX-35

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100 Patents (Medical) associated with HLX-35

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100 Deals associated with HLX-35

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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	China	Binacea Pharma, Inc.	30 Jan 2023
Metastatic Solid Tumor	Phase 1	China	Shanghai Henlius Biotech, Inc.	03 Jun 2022
Squamous non-small cell lung cancer	Phase 1	China	Shanghai Henlius Biotech, Inc.	03 Jun 2022
squamous cell lung carcinoma	Phase 1	China	Shanghai Henlius Biotech, Inc.	02 Jun 2022
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Binacea Pharma, Inc.	08 Feb 2022
Refractory Malignant Solid Neoplasm	Phase 1	Australia	Binacea Pharma, Inc.	08 Feb 2022

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Clinical Result

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Biosimilar

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