Delving into the Latest Updates on Ningbo Taikang Pharmaceutical Technology Co. Ltd. with Synapse

Overview

Tags

Neoplasms

Digestive System Disorders

Skin and Musculoskeletal Diseases

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	3

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

PIM(PIM family)	1
PDGFRα x c-Kit	1

主要目的：评价RMX1002片多次口服给药治疗晚期实体瘤患者的安全性及耐受性，确定最大耐受剂量、II期推荐剂量及给药方案。次要目的： 1.评价RMX1002片在晚期实体瘤患者体内的PK特征； 2.初步观察RMX1002片在晚期实体瘤患者中的初步疗效。探索性目的：初步探索药效动力学指标与疗效的潜在关系。

[Translation]

Primary purpose: To evaluate the safety and tolerability of multiple oral administration of RMX1002 tablets in patients with advanced solid tumors, and to determine the maximum tolerated dose, Phase II recommended dose, and dosing regimen. Secondary purpose: 1. To evaluate the PK characteristics of RMX1002 tablets in patients with advanced solid tumors; 2. To preliminarily observe the preliminary efficacy of RMX1002 tablets in patients with advanced solid tumors. Exploratory purpose: To preliminarily explore the potential relationship between pharmacodynamic indicators and efficacy.

Start Date24 May 2019

Sponsor / Collaborator

Ningbo Xinwan Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Ningbo Taikang Pharmaceutical Technology Co. Ltd.

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0 Patents (Medical) associated with Ningbo Taikang Pharmaceutical Technology Co. Ltd.

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1

Literatures (Medical) associated with Ningbo Taikang Pharmaceutical Technology Co. Ltd.

01 Jun 2024·Journal of Clinical Oncology

Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST).

Author: Hu, Kang ; Li, Jian ; Kang, Yoon-Koo ; Chi, Ping ; George, Suzanne ; Zhang, Lijia ; Zhang, Jian ; Cao, Hui ; Zhang, Jun ; Xu, Yanhua

11518 Background: NB003 is a potent and selective small-molecule tyrosine kinase inhibitor of KIT/PDGFRα. It was designed to inhibit a broad spectrum of primary and acquired imatinib-resistant mutations in KIT/PDGFRα. Methods: This is a first-in-human phase 1 study in patients (pts) with advanced GIST who progressed on or intolerant to imatinib and other SoCs. Pts received oral NB003 twice daily (BID). An accelerated titration followed by a Bayesian optimal interval (BOIN) design was used. After the MTD or MAD was determined, putative RP2D(s) were explored to establish the RP2D. The primary endpoint was safety and tolerability. Other endpoints included PK, efficacy and mutational status by ctDNA. Results: As of Jan 10, 2024, 42 pts (median age 55 y [range 33–81]; 69% male; 71.4% ECOG PS 1; 69% primary mutation in KIT exon 11; median 4 prior TKI therapies [range 2–7]) were treated in dose escalation phase. Seven dose levels (DL) were tested, including 3mg (1 pt), 6mg (1 pt), 12mg (3 pts), 20mg (15 pts), 30mg (15 pts), 35mg (4 pts), 40mg (3 pts). The most frequent treatment-related adverse events (TRAEs) were asymptomatic CPK increased (92.9%), anaemia (78.6%), AST increased, face oedema, WBC decreased (76.2% each), periorbital oedema (66.7%), neutrophil count decreased (64.3%), amylase increased (57.1%), lipase increased (52.4%), platelet count decreased (45.2%), oedema peripheral (38.1%). The most frequent Grade ≥3 TRAEs were anaemia (61.9%), asymptomatic CPK increased (59.5%), neutrophil count decreased (23.8%), WBC decreased (21.4%). TRAEs leading to treatment discontinuation were reported in 2 pts (fatigue, tumor haemorrhage) at 20mg DL, 2 pts (AST increased, WBC decreased) at 30mg DL and 1 pt (face oedema) at 40mg DL, respectively. DLTs occurred in 2 pts at 40mg DL (fatigue, face oedema) and 2 pts at 30mg DL (febrile neutropenia, rash maculo-papular, AST increased). In 42 treated pts, the confirmed ORR was 26.2% (11/42, 95% CI:13.9, 42.0) per mRECISTv1.1 by investigator assessment, DCR was 73.8% (31/42, 95% CI:58.0, 86.1). Most of the responses (7/11) are still ongoing. Tumor responses were observed in pts with a broad spectrum of acquired resistance mutations in both ATP-binding site and activation loop of the kinase domain of KIT based on predose ctDNA (including 3 pts with exon11/13, 3 pts with exon11/17, 2 pts with exon17, 1 pt with exon16, 1 pt with exon 9/17, 1 pt not detected). A correlation is observed between changes in the KIT mutation allele fraction (MAF) in ctDNA and changes in tumor size from baseline. Conclusions: In heavily pretreated pts with advanced GIST, NB003 demonstrated a manageable safety profile with encouraging antitumor activity across a broad spectrum of secondary resistance mutations in KIT. The RP2D was defined as 20mg BID based on overall safety and efficacy. Expansion cohorts in different lines of GIST are currently under enrollment. Clinical trial information: NCT04936178 .

100 Deals associated with Ningbo Taikang Pharmaceutical Technology Co. Ltd.

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100 Translational Medicine associated with Ningbo Taikang Pharmaceutical Technology Co. Ltd.

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Pipeline

Pipeline Snapshot as of 12 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

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

AZD-3229 ( PDGFRα x c-Kit )	Gastrointestinal Stromal Tumors More	Phase 1
NB-005	Solid tumor More	Phase 1
NB004 (Ningbo Xinwan) ( PIM )	Advanced Malignant Solid Neoplasm More	Phase 1
Grapiprant ( EP4 )	Advanced Malignant Solid Neoplasm More	Discontinued