Delving into the Latest Updates on Shenzhen Fuwo Pharmaceutical Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Forward Pharma is a company dedicated to the advancement of small-molecule pharmaceuticals and antibody-targeted drugs. The company's primary focus is on the research and development of innovative medications for the treatment of oncology and autoimmune diseases. With a commitment to pushing the boundaries of science, Forward Pharma strives to bring forth new and revolutionary treatments that can make a significant impact on patients' lives.

Tags

Neoplasms

Immune System Diseases

Respiratory Diseases

Small molecule drug

Monoclonal antibody

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	9
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	7
Monoclonal antibody	2
Chemical drugs	1
Biological products	1

Top 5 Target	Count

KRAS G12C(GTPase KRas G12C)	2
KRAS G12D(GTPase KRas G12D)	2
IL-13(Interleukin-13)	1
FGFR2(Fibroblast growth factor receptor 2)	1
EGFR exon 20 x HER2	1

This is a phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer The goal of this clinical trial] is to learn about in ER+/HER2- BC participant population. The main questions it aims to answer are:
Establish the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer.
Explore the safety and tolerability of FWD1802 as monotherapy and in combination with Palbociclib.
Characterise Pharmacokinetics of FWD1802 as monotherapy and in combination with palbociclib.
Explore preliminary efficacy signals.

Start Date12 Sep 2023

Sponsor / Collaborator

Shenzhen Fuwo Pharmaceutical Co. Ltd.Startup

CTR20232130 / RecruitingPhase 1

一项FWD1802单药治疗和与哌柏西利联合治疗在ER+/HER2-不可切除的局部晚期或转移性乳腺癌受试者中口服给药的安全性、耐受性、药代动力学、药效动力学和抗肿瘤初步有效的开放剂量递增、剂量扩展的I期临床研究

[Translation] An open-label, dose-escalation, dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of oral FWD1802 monotherapy and in combination with palbociclib in subjects with ER+/HER2- unresectable locally advanced or metastatic breast cancer

"主要研究目的：？确定FWD1802单药治疗和与哌柏西利联合治疗ER+/HER2-不可切除的局部晚期或转移性乳腺癌受试者的II期推荐剂量（Recommended Phase II dose，RP2D）和/或最大耐受剂量（Maximum tolerated dose，MTD）。？探索FWD1802单药治疗和与哌柏西利联合治疗的安全性和耐受性。次要研究目的：？评价FWD1802单药治疗和与哌柏西利联合治疗的药代动力学特征。？探索FWD1802在人体内的代谢途径。？探索初步疗效。探索性目的：？ FWD1802单药治疗和与哌柏西利联合治疗的生物标记物。"

[Translation]

"Main study objectives: ? To determine the recommended Phase II dose (RP2D) and/or maximum tolerated dose (MTD) of FWD1802 monotherapy and in combination with palbociclib for subjects with ER+/HER2- unresectable locally advanced or metastatic breast cancer. ? To explore the safety and tolerability of FWD1802 monotherapy and in combination with palbociclib. Secondary study objectives: ? To evaluate the pharmacokinetic characteristics of FWD1802 monotherapy and in combination with palbociclib. ? To explore the metabolic pathway of FWD1802 in humans. ? To explore the preliminary efficacy. Exploratory objectives: ? Biomarkers of FWD1802 monotherapy and in combination with palbociclib."

Start Date07 Sep 2023

Sponsor / Collaborator

Shenzhen Fuwo Pharmaceutical Co. Ltd.Startup

CTR20211750 / RecruitingPhase 1

一项评价FWD1509 MsOH在晚期非小细胞肺癌患者中的安全性、耐受性、药代动力学和抗肿瘤活性的开放性I期研究

[Translation] An open-label phase I study evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of FWD1509 MsOH in patients with advanced non-small cell lung cancer

主要目的：1.评价FWD1509 MsOH治疗晚期EGFR突变型和/或HER2突变型NSCLC患者的安全性与耐受性；2.评价晚期EGFR突变型和/或HER2突变型NSCLC患者单、多次服用FWD1509 MsOH后FWD1509 MsOH和主要代谢产物（M13）的药代动力学特征。剂量扩展阶段主要目的：评价FWD1509 MsOH治疗晚期EGFR exon 20ins 和/或HER2突变NSCLC患者的有效性；次要目的：确定FWD1509 MsOH在晚期EGFR突变型和/或HER2突变型NSCLC患者中的DLT、MTD、RP2D；初步抗肿瘤活性。剂量扩展阶段次要目的：1.评价FWD1509 MsOH治疗晚期EGFR exon 20ins 和/或HER2突变NSCLC患者的安全性；2. 评价晚期NSCLC患者服用FWD1509 MsOH后FWD1509 MsOH和主要代谢产物（M13）的PK特征。3. 确定FWD1509 MsOH在晚期EGFR突变型和/或HER2突变型NSCLC患者中的RP2D。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of FWD1509 MsOH in the treatment of patients with advanced EGFR mutant and/or HER2 mutant NSCLC; 2. To evaluate the pharmacokinetic characteristics of FWD1509 MsOH and its main metabolite (M13) after single and multiple doses of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC. Primary objectives of the dose expansion phase: To evaluate the efficacy of FWD1509 MsOH in the treatment of patients with advanced EGFR exon 20ins and/or HER2 mutant NSCLC; Secondary objectives: To determine the DLT, MTD, RP2D of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC; Preliminary anti-tumor activity. Secondary objectives of the dose expansion phase: 1. To evaluate the safety of FWD1509 MsOH in the treatment of patients with advanced EGFR exon 20ins and/or HER2 mutant NSCLC; 2. To evaluate the PK characteristics of FWD1509 MsOH and the main metabolite (M13) in patients with advanced NSCLC after taking FWD1509 MsOH. 3. To determine the RP2D of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC.

Start Date23 Sep 2021

Sponsor / Collaborator

Shenzhen Fuwo Pharmaceutical Co. Ltd.Startup

100 Clinical Results associated with Shenzhen Fuwo Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Shenzhen Fuwo Pharmaceutical Co. Ltd.

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1

Literatures (Medical) associated with Shenzhen Fuwo Pharmaceutical Co. Ltd.

22 Jun 2021·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

Potency boost of a Mycobacterium tuberculosis dihydrofolate reductase inhibitor by multienzyme F ₄₂₀ H ₂ -dependent reduction

Q1 · CROSS-FIELD

Article

Author: Gengenbacher, Martin ; Chui, Wai-Keung ; Zimmerman, Matthew D. ; Yang, Xuan ; Jackson, Colin J. ; Aragaw, Wassihun Wedajo ; Dartois, Véronique ; Lee, Brendon M. ; Dick, Thomas

SignificanceBacterial metabolism can cause intrinsic drug resistance but can also convert inactive parent drugs into bioactive derivatives, as is the case for several antimycobacterial prodrugs. Here, we show that the intrabacterial metabolism of a Mtb dihydrofolate reductase (DHFR) inhibitor with moderate affinity for its target boosts its on-target activity by two orders of magnitude. This is a “prodrug-like” antimycobacterial that possesses baseline activity in the absence of intracellular bioactivation. By elucidating the metabolic enhancement mechanism, we have provided the basis for the rational optimization of a class of DHFR inhibitors and uncovered an antibacterial drug discovery concept.

100 Deals associated with Shenzhen Fuwo Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Shenzhen Fuwo Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 05 Oct 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

8

Preclinical

Phase 1 Clinical

1

Phase 2 Clinical

Other

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

FWD-1509 ( EGFR exon 20 x HER2 )	Advanced Lung Non-Small Cell Carcinoma More	Phase 2 Clinical
FWD-1802 ( ER )	Metastatic breast cancer More	Phase 1
FWD-K01 ( KRAS G12C )	Neoplasms More	Preclinical
FWD-H01	-	Preclinical
EGFR2 inhibitors (Shenzhen Forward Pharmaceuticals) ( FGFR2 )	Neoplasms More	Preclinical