Delving into the Latest Updates on Therawisdom Biopharma Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Digestive System Disorders

Skin and Musculoskeletal Diseases

Monoclonal antibody

Fusion protein

Biological products

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	3

Top 5 Drug Type	Count

Monoclonal antibody	2
Bispecific antibody	1
Fusion protein	1
Biological products	1

Top 5 Target	Count

4-1BB(Tumor necrosis factor receptor superfamily member 9)	1
CD27(CD27 antigen)	1
FSHR(Follicle-stimulating hormone receptor)	1
CD19(B-lymphocyte antigen CD19)	1

This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.

Start Date08 Mar 2022

Sponsor / Collaborator

Therawisdom Biopharma Co., Ltd.

CTR20212364 / RecruitingPhase 1

TWP-102注射液在晚期恶性肿瘤患者中的安全性、耐受性、药代动力学、药效动力学特征、免疫原性以及初步疗效的多中心、开放、剂量递增和剂量扩展的I期临床研究

[Translation] A multicenter, open-label, dose-escalation and dose-expansion Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamic characteristics, immunogenicity and preliminary efficacy of TWP-102 injection in patients with advanced malignant tumors

主要目的： a. 评估TWP-102注射液在晚期恶性肿瘤受试者中的安全性和耐受性； b. 通过剂量限制性毒性（DLT）的发生率，确定TWP-102注射液在晚期恶性肿瘤受试者中最大耐受剂量（MTD）；次要目的： a. 评估TWP-102注射液在晚期恶性肿瘤受试者中的药代动力学特征； b. 评估TWP-102注射液在晚期恶性肿瘤受试者中的药效动力学特征； c. 评估TWP-102注射液在晚期恶性肿瘤受试者中的免疫原性； d. 采用实体瘤疗效评价标准（RECIST）v1.1评估TWP-102注射液在晚期实体瘤受试者中的初步抗肿瘤活性；采用2014版Lugano评价标准评估TWP-102注射液在非霍奇金淋巴瘤受试者中的的初步抗肿瘤活性。探索性目的： a. 采用免疫治疗实体瘤疗效评价标准（iRECIST）标准探索性评估TWP-102注射液在晚期实体瘤受试者中的初步抗肿瘤活性； b. 探索检测TWP-102注射液治疗晚期恶性肿瘤疗效的生物标志物。

[Translation]

Primary objectives: a. To evaluate the safety and tolerability of TWP-102 injection in subjects with advanced malignant tumors; b. To determine the maximum tolerated dose (MTD) of TWP-102 injection in subjects with advanced malignant tumors by the incidence of dose-limiting toxicity (DLT); Secondary objectives: a. To evaluate the pharmacokinetic characteristics of TWP-102 injection in subjects with advanced malignant tumors; b. To evaluate the pharmacodynamic characteristics of TWP-102 injection in subjects with advanced malignant tumors; c. To evaluate the immunogenicity of TWP-102 injection in subjects with advanced malignant tumors; d. To evaluate the preliminary antitumor activity of TWP-102 injection in subjects with advanced solid tumors using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; and to evaluate the preliminary antitumor activity of TWP-102 injection in subjects with non-Hodgkin's lymphoma using the 2014 version of the Lugano evaluation criteria. Exploratory purpose: a. To explore the preliminary anti-tumor activity of TWP-102 injection in subjects with advanced solid tumors using the immunotherapy efficacy evaluation criteria in solid tumors (iRECIST) standard; b. To explore biomarkers for detecting the efficacy of TWP-102 injection in the treatment of advanced malignant tumors.

Start Date25 Feb 2022

Sponsor / Collaborator

Therawisdom Biopharma Co., Ltd.

CTR20211016 / RecruitingPhase 1

一项多中心，开放，评价西达珠单抗在晚期实体瘤患者中安全性和有效性的Ia/Ib期临床研究

[Translation] A multicenter, open-label, phase Ia/Ib clinical study evaluating the safety and efficacy of cedarizumab in patients with advanced solid tumors

主要目的评价西达珠单抗在晚期实体瘤患者中的安全性和耐受性；次要目的确定西达珠单抗在晚期实体瘤患者中的有效性，为后期临床推荐实体瘤适应症。评价西达珠单抗的药代动力学特征。评价西达珠单抗的免疫原性。探索目的采用iRECIST标准（2017）探索性评价西达珠单抗的抗肿瘤活性；探索西达珠单抗的药效学特征；探索相关生物标志物与临床疗效的关系。

[Translation]

Primary objective To evaluate the safety and tolerability of cedarizumab in patients with advanced solid tumors; Secondary objective To determine the effectiveness of cedarizumab in patients with advanced solid tumors and recommend solid tumor indications for later clinical trials. To evaluate the pharmacokinetic characteristics of cedarizumab. To evaluate the immunogenicity of cedarizumab. Exploratory objective To explore the anti-tumor activity of cedarizumab using the iRECIST standard (2017); To explore the pharmacodynamic characteristics of cedarizumab; To explore the relationship between relevant biomarkers and clinical efficacy.

Start Date10 Sep 2021

Sponsor / Collaborator

Therawisdom Biopharma Co., Ltd.

[+1]

100 Clinical Results associated with Therawisdom Biopharma Co., Ltd.

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0 Patents (Medical) associated with Therawisdom Biopharma Co., Ltd.

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100 Deals associated with Therawisdom Biopharma Co., Ltd.

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100 Translational Medicine associated with Therawisdom Biopharma Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 Nov 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

2

1

IND Approval

Phase 1 Clinical

3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Sytalizumab ( 4-1BB )	Advanced Malignant Solid Neoplasm More	Phase 1
TWP-201 ( FSHR )	Infertility More	Phase 1
TWP-102	Advanced cancer More	Phase 1
TWP-103	Solid tumor More	IND Approval
CN116262789 ( CD27 )	Neoplasms More	Discovery