Delving into the Latest Updates on D3 Bio (Wuxi) Co. Ltd with Synapse

Overview

Basic Info

Introduction

D3 Bio (Wuxi) Co. Ltd., based in Wuxi, China, specializes in the production of pharmaceuticals. The company was established in 2020 by three founders, Zhi Jian Chen, Fen Yu Jin, and John Jin. Under the brand name D3 Bio, the company operates globally within the biotechnology industry, focusing on the development and commercialization of precision medicines. They strive to enhance or replace current standard-of-care treatments in oncology and immunology that inadequately meet patient needs. Through collaborations with top-tier partners globally, D3 Bio marries deep insights about the healthcare treatment landscape with innovative science and technology.

Tags

Neoplasms

Digestive System Disorders

Respiratory Diseases

Bispecific antibody

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	6
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Bispecific antibody	3
Small molecule drug	3

Top 5 Target	Count

KRAS G12C(GTPase KRas G12C)	1
CD47 x HER2(Cluster of differentiation 47 x Receptor tyrosine-protein kinase erbB-2)	1
ERK1 x ERK2(Extracellular-signal-regulated kinase1 x Extracellular-signal-regulated kinase 2)	1

主要目的：？评价D3L-001在HER2阳性实体瘤成人受试者中的安全性和耐受性。？确定最大耐受剂量（MTD）（如适用）和2期推荐剂量（RP2D）。次要目的：？表征D3L-001的PK特征。？评价免疫原性（免疫原性定义为抗药抗体（ADA）的发生率）。？评价D3L-001单药治疗HER2阳性晚期实体瘤的肿瘤缓解情况。

[Translation]

main purpose: ? To evaluate the safety and tolerability of D3L-001 in adult subjects with HER2-positive solid tumors. ? Determine the maximum tolerated dose (MTD) (if applicable) and recommended phase 2 dose (RP2D). Secondary purpose: ? Characterizing the PK profile of D3L-001. ? Immunogenicity was evaluated (immunogenicity was defined as the incidence of anti-drug antibodies (ADA)). ? To evaluate the tumor response of D3L-001 monotherapy in the treatment of HER2-positive advanced solid tumors.

Start Date31 Jan 2024

Sponsor / Collaborator

D3 Bio (Wuxi) Co. Ltd

CTR20233589 / RecruitingPhase 1

一项在携带MAPK通路突变的晚期实体瘤成人受试者中评价D3S-002单药治疗的安全性、耐受性、药代动力学和2期推荐剂量的开放标签、剂量递增1期研究

[Translation] An open-label, dose-escalation Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and recommended Phase 2 dose of D3S-002 monotherapy in adult subjects with advanced solid tumors harboring MAPK pathway mutations

主要目的 · 评价D3S-002在携带丝裂原活化蛋白激酶（MAPK）通路突变的晚期实体瘤成人受试者中的安全性和耐受性 · 在成人受试者中确定最大耐受剂量和2期推荐剂量（RP2D）次要目的 · 表征D3S-002片剂口服给药后的药代动力学（PK） · 根据实体瘤疗效评价标准（RECIST）1.1评估结果，评价D3S-002单药治疗携带MAPK通路突变的晚期实体瘤的肿瘤缓解情况探索性目的鉴定D3S-002代谢产物

[Translation]

main purpose · To evaluate the safety and tolerability of D3S-002 in adult subjects with advanced solid tumors harboring mitogen-activated protein kinase (MAPK) pathway mutations · Determining the maximum tolerated dose and recommended phase 2 dose (RP2D) in adult subjects secondary purpose · Characterizing the pharmacokinetics (PK) of D3S-002 tablets following oral administration · Based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 evaluation results, evaluate the tumor response of D3S-002 monotherapy in the treatment of advanced solid tumors harboring MAPK pathway mutations. exploratory purpose Identification of D3S-002 metabolites

Start Date03 Jan 2024

Sponsor / Collaborator

D3 Bio (Wuxi) Co. Ltd

NCT05957536 / RecruitingPhase 1

A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.

This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.

Start Date19 Sep 2023

Sponsor / Collaborator

D3 Bio (Wuxi) Co. Ltd

100 Clinical Results associated with D3 Bio (Wuxi) Co. Ltd

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0 Patents (Medical) associated with D3 Bio (Wuxi) Co. Ltd

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100 Deals associated with D3 Bio (Wuxi) Co. Ltd

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100 Translational Medicine associated with D3 Bio (Wuxi) Co. Ltd

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Pipeline

Pipeline Snapshot as of 05 Jul 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

1

2

Preclinical

Phase 1 Clinical

3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

D3S-001 ( KRAS G12C )	KRAS G12C mutation Solid Tumors More	Phase 1
D3L-001 ( CD47 x HER2 )	HER2 Positive Breast Cancer More	Phase 1
D3S-002 ( ERK1 x ERK2 )	MAPK mutation Solid Tumors More	Phase 1
D3L-002	Solid tumor More	Preclinical
D3L-003	Solid tumor More	Preclinical