Delving into the Latest Updates on RegeneCore Biotech Co., Ltd with Synapse

Overview

Basic Info

Introduction

RegeneCore Biotech Co., Ltd. is located in the National Jiangbei New Area Biomedical Valley in Nanjing. The company focuses on research and development in neurobiology, biopharmaceuticals using nanobody technology, and cell therapy utilizing nanobody techniques. It has established comprehensive platforms for antibody screening, ADC antibody drug technology, and both universal and specific cell therapy techniques.

Tags

Neoplasms

Immune System Diseases

Respiratory Diseases

Nanobody

Monoclonal antibody

Bispecific antibody

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
Immune System Diseases	7
Nervous System Diseases	2
Hemic and Lymphatic Diseases	2
Infectious Diseases	1

Top 5 Drug Type	Count

Nanobody	12
Monoclonal antibody	6
Bispecific antibody	2

Top 5 Target	Count

IL2RA(Interleukin-2 receptor alpha chain)	1
IL-17A x TNF-α	1
IL-4Rα x IL-5	1
LAG3(Lymphocyte activation gene 3 protein)	1
SARS-CoV-2 antigen	1

1.主要目的：评估 RJK-RT2831 在恶性血液肿瘤受试者中的安全性、耐受性和最大耐受剂量。确定 RJK-RT2831 治疗恶性血液肿瘤受试者的扩展期推荐剂量。 2.次要目的：评估 RJK-RT2831 在恶性血液肿瘤受试者中单、多次给药的药代动力学特征。评估 RJK-RT2831 在恶性血液肿瘤受试者中的初步抗肿瘤活性。评估 RJK-RT2831 在恶性血液肿瘤受试者中的免疫原性。

[Translation]

1. Primary objectives: To evaluate the safety, tolerability and maximum tolerated dose of RJK-RT2831 in subjects with hematological malignancies. To determine the recommended dose of RJK-RT2831 for the extension phase of the treatment of subjects with hematological malignancies. 2. Secondary objectives: To evaluate the pharmacokinetic characteristics of single and multiple administrations of RJK-RT2831 in subjects with hematological malignancies. To evaluate the preliminary anti-tumor activity of RJK-RT2831 in subjects with hematological malignancies. To evaluate the immunogenicity of RJK-RT2831 in subjects with hematological malignancies.

Start Date-

Sponsor / Collaborator

RegeneCore Biotech Co., Ltd

NCT06067490 / RecruitingPhase 1

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andImmunogenicity of RC1416 Injection Via Subcutaneous Administration in Healthy Adult Volunteers.

This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.

Start Date03 Jul 2023

Sponsor / Collaborator

RegeneCore Biotech Co., Ltd

CTR20231870 / RecruitingPhase 1

评价RC1416注射液在中国健康受试者中单次给药后的耐受性、安全性、药代动力学、药效学特征和免疫原性的Ⅰa期临床研究

[Translation] A Phase Ia clinical study to evaluate the tolerability, safety, pharmacokinetics, pharmacodynamic characteristics and immunogenicity of RC1416 injection after a single dose in healthy Chinese subjects

主要研究目的：评估在健康受试者中剂量递增、单次皮下注射RC1416注射液的安全性与耐受性。次要研究目的：评估在健康受试者中剂量递增、单次皮下注射RC1416注射液的药代动力学、药效学和免疫原性特征、为后续Ⅰb/Ⅱ期研究给药剂量及给药间隔设计提供依据。

[Translation]

The primary study objective is to evaluate the safety and tolerability of RC1416 injection in healthy subjects after a single subcutaneous injection with increasing doses. The secondary study objective is to evaluate the pharmacokinetic, pharmacodynamic and immunogenic characteristics of RC1416 injection in healthy subjects after a single subcutaneous injection with increasing doses, and to provide a basis for the design of dosing and dosing intervals in subsequent Phase Ib/II studies.

Start Date29 Jun 2023

Sponsor / Collaborator

RegeneCore Biotech Co., Ltd

100 Clinical Results associated with RegeneCore Biotech Co., Ltd

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0 Patents (Medical) associated with RegeneCore Biotech Co., Ltd

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2

Literatures (Medical) associated with RegeneCore Biotech Co., Ltd

01 Dec 2021·European Journal of Medicinal ChemistryQ1 · MEDICINE

A review of synthetic bioactive tetrahydro-β-carbolines: A medicinal chemistry perspective

Q1 · MEDICINE

Review

Author: Gong, Feihu ; Gao, Jinming ; Liang, Ting ; Cao, Chenyu ; Lu, Tao ; Yang, Yingxiang ; Wang, Jiayun ; Chen, Xin ; Xie, Zhao

1, 2, 3, 4-Tetrahydro-β-carboline (THβC) scaffold is widespread in many natural products (NPs) and synthetic compounds which show a variety of pharmacological activities. In this article, we reviewed the design, structures and biological characteristics of reported synthetic THβC compounds, and structure and activity relationship (SAR) of them were also discussed. This work might provide a reference for subsequent drug development based on THβC.

Frontiers in Immunology

Broadening anticancer spectrum by preprocessing and treatment of T- lymphocytes expressed FcγRI and monoclonal antibodies for refractory cancers

Article

Author: Ma, Yuxiao ; Xu, Xinyu ; Tang, Lei ; Guo, Wei ; Meng, Jinguo ; Sun, Qinyi ; Zeng, Aizhong ; Li, Mengyuan ; Liu, Yuanyuan ; Yu, Xiaoxiao ; Zhang, Yun ; Li, Zhuolan

BackgroundChimeric antigen receptor T (CAR-T) cell therapies have achieved remarkable success in the treatment of hematological tumors. However, given the distinct features of solid tumors, particularly heterogeneity, metabolic aggressiveness, and fewer immune cells in tumor microenvironment (TME), the practical utility of CAR-T cells for solid tumors remains as a challenging issue. Meanwhile, although anti-PD-1 monoclonal antibody (mAb) has shown clinical efficacy, most mAbs also show limited clinical benefits for solid tumors due mainly to the issues associated with the lack of immune cells in TME. Thus, the infiltration of targeted immunological active cells into TME could generate synergistic efficacy for mAbs.MethodsWe present a combinational strategy for solid tumor treatment, which combines armored-T cells to express Fc-gamma receptor I (FcγRI) fragment on the surfaces for targeting various tumors with therapeutically useful mAbs. Choosing CD20 and HER-2 as the targets, we characterized the in vitro and in vivo efficacy and latent mechanism of the combination drug by using flow cytometry, ELISA and other methods.ResultsThe combination and preprocessing of armored T-cells with corresponding antibody of Rituximab and Pertuzumab exerted profound anti-tumor effects, which is demonstrated to be mediated by synergistically produced antibody-dependent cellular cytotoxicity (ADCC) effects. Meanwhile, mAb was able to carry armored-T cell by preprocessing for the infiltration to TME in cell derived xenograft (CDX) model.ConclusionsThis combination strategy showed a significant increase of safety profiles from the reduction of antibody doses. More importantly, the present strategy could be a versatile tool for a broad spectrum of cancer treatment, with a simple pairing of engineered T cells and a conventional antibody.

100 Deals associated with RegeneCore Biotech Co., Ltd

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100 Translational Medicine associated with RegeneCore Biotech Co., Ltd

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Pipeline

Pipeline Snapshot as of 28 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

13

5

Preclinical

Phase 1 Clinical

2

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

RC1416 ( IL-4Rα x IL-5 )	Severe asthma More	Phase 1
RJK-RT2831	Hematologic Neoplasms More	Phase 1
RC-1404	Autoimmune Diseases More	Preclinical
RN-0051	Nervous System Diseases More	Preclinical
RT-0902	Solid tumor More	Preclinical