Delving into the Latest Updates on ABO2011 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, mRNA vaccine, Liposomal Drug

Synonyms

LNP-IL12 mRNA, ABO 2011, ABO-2011

+ [1]

Target

IL-12

Action

stimulants

Mechanism

IL-12 stimulants(Interleukin-12 stimulants)

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Advanced Malignant Solid NeoplasmNasopharyngeal Carcinoma

Inactive Indication-

Originator Organization

Suzhou Abogen Biosciences Co., Ltd.

Active Organization

Suzhou Abogen Biosciences Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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试验主要目的是评价ABO2011的安全性和耐受性，并探索最大耐受剂量（MTD）以及确定ABO2011的Ⅱ期临床试验推荐剂量（RP2D）；次要目的是评价ABO2011的初步有效性、PK和PD特征以及免疫原性，同时分析分子标记物与有效性和安全性的关系以及评价外周血中炎性细胞因子、肿瘤组织内部免疫微环境的变化和肿瘤免疫相关基因表达的变化

[Translation]

The primary purpose of the trial is to evaluate the safety and tolerability of ABO2011, explore the maximum tolerated dose (MTD) and determine the recommended dose (RP2D) for Phase II clinical trials of ABO2011; the secondary purpose is to evaluate the preliminary efficacy, PK and PD characteristics and immunogenicity of ABO2011, analyze the relationship between molecular markers and efficacy and safety, and evaluate the changes in inflammatory cytokines in peripheral blood, changes in the immune microenvironment in tumor tissue, and changes in the expression of tumor immune-related genes.

Start Date28 Sep 2023

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

[+1]

CTR20240149

/ RecruitingPhase 1/2

一项在晚期实体瘤患者中评估ABO2011单药及与特瑞普利单抗联合的安全性、药代动力学和药效学（PK/PD）及初步有效性的I/II期临床研究

[Translation] A Phase I/II clinical study evaluating the safety, pharmacokinetics and pharmacodynamics (PK/PD) and preliminary efficacy of ABO2011 alone and in combination with toripalimab in patients with advanced solid tumors

I期 1. 评价ABO2011单药及与特瑞普利单抗联合的安全性和耐受性 2. 确定ABO2011单药及与特瑞普利单抗联合的推荐剂量和/或最大耐受剂量（MTD） II期 1. 评估ABO2011单药及与特瑞普利单抗联合的初步抗肿瘤作用

[Translation]

Phase I 1. Evaluate the safety and tolerability of ABO2011 alone and in combination with toripalimab 2. Determine the recommended dose and/or maximum tolerated dose (MTD) of ABO2011 alone and in combination with toripalimab Phase II 1. Evaluate the preliminary anti-tumor effect of ABO2011 alone and in combination with toripalimab

Start Date28 Sep 2023

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

[+1]

NCT06088004

/ RecruitingPhase 1/2

A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics (PK/PD) and Preliminary Efficacy of ABO2011 Monotherapy or in Combination With Toripalimab in Patients With Advanced Solid Tumors

This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.

Start Date28 Sep 2023

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

100 Clinical Results associated with ABO2011

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100 Translational Medicine associated with ABO2011

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100 Patents (Medical) associated with ABO2011

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100 Deals associated with ABO2011

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Suzhou Abogen Biosciences Co., Ltd.	28 Sep 2023
Nasopharyngeal Carcinoma	Phase 2	China	Suzhou Abogen Biosciences Co., Ltd.	-