Delving into the Latest Updates on Abogen Biotechnology (Shanghai) Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Abogen Biotechnology (Shanghai) Co., Ltd. is an innovative biopharmaceutical company specializing in the development of mRNA drugs. It owns proprietary mRNA and nanoparticle delivery technology platforms that cover all aspects, from mRNA design, formulation development, to large-scale production. Currently, the company has established a rich product pipeline, covering multiple fields including prevention and treatment of infectious diseases such as mRNA COVID-19 vaccine, tumor immunity, protein replacement therapy, and more.

This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.

Start Date24 Mar 2026

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

[+1]

CTR20255113

/ RecruitingPhase 1

一项在携带KRAS突变的实体瘤患者中评估ABO2102安全性、耐受性、免疫原性、药代动力学和药效学特征及初步抗肿瘤活性的I期临床研究

[Translation] A phase I clinical study evaluating the safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic characteristics and preliminary antitumor activity of ABO2102 in patients with KRAS-mutant solid tumors.

第一阶段：评估 ABO2102单药及联合信迪利单抗在KRAS突变的局部晚期或转移性实体瘤患者中的安全性和耐受性，确定最大耐受剂量（MTD）和/或第二阶段推荐剂量（RD）探索性目的：评估信迪利单抗在研究人群中的免疫原性指标、评估信迪利单抗在研究人群中的PK指标、初步评估ABO2102在KRAS突变的实体瘤患者中的其他疗效指标第二阶段：初步评估 ABO2102联合用药在KRAS突变的非小细胞肺癌（NSCLC）患者中的有效性探索性目的：评估信迪利单抗在研究人群中的免疫原性指标、评估信迪利单抗在研究人群中的PK指标、初步评估ABO2102在KRAS突变的NSCLC患者中的其他疗效指标

[Translation]

Phase 1: Evaluate the safety and tolerability of ABO2102 monotherapy and in combination with sintilimab in patients with KRAS-mutant locally advanced or metastatic solid tumors, and determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for Phase 2. Exploratory objectives: Evaluate the immunogenicity markers of sintilimab in the study population, evaluate the pharmacokinetic (PK) markers of sintilimab in the study population, and preliminarily evaluate other efficacy endpoints of ABO2102 in patients with KRAS-mutant solid tumors. Phase 2: Preliminarily evaluate the efficacy of ABO2102 in combination therapy in patients with KRAS-mutant non-small cell lung cancer (NSCLC). Exploratory objectives: Evaluate the immunogenicity markers of sintilimab in the study population, evaluate the pharmacokinetic (PK) markers of sintilimab in the study population, and preliminarily evaluate other efficacy endpoints of ABO2102 in patients with KRAS-mutant NSCLC.

Start Date06 Mar 2026

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

[+1]

NCT07285278

/ Active, not recruitingPhase 2

A Randomized, Blinded and Placebo-Control Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above

The primary objective of this study is to evaluate the immunogenicity and safety of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.

Start Date15 Nov 2025

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

[+1]

100 Clinical Results associated with Abogen Biotechnology (Shanghai) Co., Ltd.

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