Delving into the Latest Updates on Hangzhou Adcoris Biopharmacy Co., Ltd with Synapse

Overview

Basic Info

Introduction

Adcoris is a clinical stage biopharmaceutical company focusing on developing the new generation antibody drug conjugate (ADC) and antibody conjugate beyond cytotoxic payload (AXC) therapeutics. Adcoris’ cutting edge ADC platform consists of three pillars: proprietary and highly active payloads (PHAP™), cleavable, flexible and stable linkers (CLEFS™), multifunctional site-specific conjugation (MuSC™).

Tags

Neoplasms

Urogenital Diseases

Endocrinology and Metabolic Disease

Antibody drug conjugate (ADC)

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	10
Endocrinology and Metabolic Disease	3
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Antibody drug conjugate (ADC)	10

Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	2
nectin-4	1
Trop-2(Tumor-associated calcium signal transducer 2)	1
5T4(Trophoblast glycoprotein)	1

主要目的：评估ACR246在晚期实体瘤患者中的安全性和耐受性，确定ACR246的最大耐受剂量（MTD）和Ⅱ期推荐剂量（RP2D）。次要目的：评估ACR246、重组抗滋养层糖蛋白5T4（以下简称“5T4”）全人源化单克隆抗体（IP140B）、毒素分子D2102在晚期实体瘤患者体内的药代动力学（PK）特征；评估ACR246在晚期实体瘤患者中的免疫原性；评估ACR246在晚期实体瘤患者中的有效性；检测肿瘤组织5T4表达，探索其与有效性指标的相关性；探索ACR246在5T4表达的晚期实体瘤患者中暴露与效应之间的关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of ACR246. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of ACR246, recombinant anti-trophoblast glycoprotein 5T4 (hereinafter referred to as "5T4") fully humanized monoclonal antibody (IP140B), and toxin molecule D2102 in patients with advanced solid tumors; To evaluate the immunogenicity of ACR246 in patients with advanced solid tumors; To evaluate the effectiveness of ACR246 in patients with advanced solid tumors; To detect the expression of 5T4 in tumor tissues and explore its correlation with effectiveness indicators; To explore the relationship between exposure and effect of ACR246 in patients with advanced solid tumors expressing 5T4.

Start Date-

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

NCT06238401 / Not yet recruitingPhase 1

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase I/II.a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients With Advanced Solid Tumors

The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246.

Start Date01 Mar 2024

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

NCT05423977 / Enrolling by invitationPhase 1

An Open-label, Multicenter, Phase I Dose-escalation Study to Assess the Safety, Pharmacokinetic (PK), Immunogenicity and Preliminary Anti-tumor Activity of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors

Start Date17 Dec 2021

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

100 Clinical Results associated with Hangzhou Adcoris Biopharmacy Co., Ltd

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0 Patents (Medical) associated with Hangzhou Adcoris Biopharmacy Co., Ltd

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2

Literatures (Medical) associated with Hangzhou Adcoris Biopharmacy Co., Ltd

01 Jun 2024·Journal of Clinical Oncology

Preclinical studies of an innovative 5T4-ADC ACR246 with the potential to better treat 5T4-positive solid tumors.

Author: Manchukonda, Naresh kumar ; Li, Deliang ; LU, Yao ; Yang, Li ; Wang, Xiaobei ; Li, Yaowu ; Miao, Zhenwei ; Wang, Feng ; Wu, Kai ; Huang, Yunsheng ; Sheng, Guorong ; Weng, Shanhui ; Huang, Xiuying

e15005 Background: 5T4 oncofetal antigen shows limited expression in normal adult tissues but highly expressed by many different cancers. It drives spread of cancer cells through epithelial mesenchymal transition (EMT), potentiation of CXCL12/CXCR4 chemotaxis and favoring non-canonical Wnt pathway, leading to poor prognosis of cancer patients. Besides, 5T4 has a highly efficient endocytosis ability which enables it to be an ideal target for the development of ADC drugs. A handful of 5T4-targeted ADCs have been evaluated in early phase clinical trials for several years showing only preliminary anti-tumor activity. However, uncertainty of their safety profiles has also raised concerns due to high toxic payloads, MMAF and duocarmycin, being used. Thus, additional approaches to this target with the potential of improved efficacy and reduced toxicity are needed urgently. ACR246, an innovative 5T4-targeted ADC consisting of specific humanized monoclonal antibody site-specifically conjugated with a cell penetrating and moderate toxic payload (DNA topoisomerase I inhibitor, D2102) that has a robust bystander effect through a stable and cleavable linker, with a drug-to-antibody ratio (DAR) of 8, was designed to improve the safety and efficacy in treating tumor patients. Methods: The pharmacologic profiles of ACR246 were assessed in vitro and in vivo including efficacy, pharmacokinetics-pharmacodynamics (PK-PD), safety, and tissue distribution, in 5T4-positive cell lines, cell-derived xenograft (CDX) models and cynomolgus monkeys. Results: ACR246 bound specifically to 5T4 and was internalized into tumor cells followed by D2102 release, which induced DNA damage, cell cycle arrest and apoptosis in 5T4 positive tumor cells in vitro. In vivo low systemic exposure and tumor-specific accumulation of D2102 rendered ACR246 superior efficacy and safety property. Accordingly, ACR246 exhibited robust in vivo anti-tumor activity across various types of 5T4 positive CDX models in a dose-dependent manner, with DNA damage induced by the accumulated D2102 in tumor tissue. GLP toxicity studies indicated that ACR246 was well tolerated in cynomolgus monkeys. The estimated therapeutic index was 24. Conclusions: The overall preclinical profile marks ACR246 has the potential to become the best in class (BIC) 5T4-ADC, showing more favorable benefit-risk ratio in clinic.

01 Jun 2024·Journal of Clinical Oncology

Phase 1 study of ZV0203, a first in class pertuzumab ADC, in patients with HER2 positive advanced solid tumors.

Author: LU, Yao ; Huang, Xiuying ; Wang, Feng ; Huang, Yong ; Lin, Fengjuan ; Huang, Yunsheng ; Miao, Zhenwei ; Rao, Xi

e15004 Background: ZV0203, a first in class (FIC) pertuzumab antibody-drug conjugate (ADC), targets HER2 positive tumor cells with tubulin inhibitor DUO5 as its payload via a stable and protease-cleavable valine-citrulline linker. In preclinical studies, ZV0203 demonstrated superior antitumor activity compared to Kadcyla in multiple tumor cell line xenograft models with no noticeable toxicity. GLP toxicity studies indicated that ZV0203 was well tolerated with an estimated therapeutic index of 35. Methods: This was an open-label, multicenter, phase 1, dose-escalation study in patients (pts) with HER2+ advanced solid tumors. Primary objectives were safety, tolerability and RP2D. Secondary objectives included PK, immunogenicity and preliminary clinical efficacy. ZV0203 was administered intravenously Q3W on a 21-day cycle. An accelerated titration design was used for the 0.3 and 0.6 mg/kg doses, followed by a 3+3 design for 1.2, 1.8, 2.7 and 3.6 mg/kg dose levels. Results: As of January 18, 2024, 15 pts with solid tumors (breast [11], colorectal [2], gastric [1], lung [1]) were enrolled across doses of 0.3-3.6 mg/kg with a median age of 52 years old (range 35-65), of which 9 pts received prior HER2-targeted therapy (trastuzumab ± pertuzumab) and 14 pts completed 21-day DLT assessment (0.3 mg/kg and 0.6 mg/kg [1 each], 1.2 mg/kg, 1.8 mg/kg, 2.7 mg/kg and 3.6mg/kg [3 each]) with no DLT incidence. Treatment-related adverse events (TRAE) occurred in 14 (93.3%) pts. The most frequent TRAEs were corneal epitheliopathy [9], elevated liver enzymes [6], dry eyes [6], neutropenia [4], anemia [4], leukopenia [3], and proteinuria [3], and most were grade 1-2 in severity. 5 pts experienced grade 3 TRAEs: lymphocytopenia (1.8mg/kg [1]) , corneal epitheliopathy (3.6 mg/kg [1]) and blurred vision (2.7 mg/kg [2], 3.6 mg/kg [1]), which were manageable during treatment. No unexpected safety signals were reported. TRAEs led to 13.3% (2/15) treatment discontinuation. Among 14 pts evaluated, 5 pts achieved a best tumor response of PR; 4 pts had SD; 1 pt had Non-CR/Non-PD per RECIST v1.1. Thus, disease control rate was 71.4% (10/14). PK results demonstrated that the PK profile of total antibody was similar to that of ZV0203 ADC, whose systematic exposure increased in a dose-dependent manner and remained stable after repeated administration. Concentration of DUO5 remained scarce, suggesting good stability of ZV0203. Conclusions: ZV0203 was well tolerated and showed clinically encouraging anti-tumor activity in heavily pretreated pts with HER2 positive cancer. Clinical trial information: NCT05423977 .

100 Deals associated with Hangzhou Adcoris Biopharmacy Co., Ltd

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100 Translational Medicine associated with Hangzhou Adcoris Biopharmacy Co., Ltd

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Pipeline

Pipeline Snapshot as of 02 Dec 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

4

Preclinical

Phase 1 Clinical

1

Phase 2 Clinical

Other

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ACR246 ( 5T4 )	Ovarian Cancer More	Phase 2 Clinical
ADC-2122 ( HER2 )	HER2 Positive Solid Tumors More	Phase 1
ADC-2284	Ovarian Cancer More	Preclinical
ADC-2202 ( HER2 )	HER2-Low Breast Carcinoma More	Preclinical
ADC-2204 ( nectin-4 )	Solid tumor More	Preclinical