Delving into the Latest Updates on WSD-0922 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [2]

Target

EGFR x EGFRvIII

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), EGFRvIII antagonists(Epidermal growth factor receptor variant III antagonists)

Therapeutic Areas

NeoplasmsNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

Advanced Lung Non-Small Cell CarcinomaEGFR positive non-small cell lung cancerBrain metastases+ [3]

Inactive Indication-

Originator Organization

Vision Biological Technology (Hefei) Co., Ltd.

Active Organization

Vision Biological Technology (Hefei) Co., Ltd.

Wayshine Biopharm

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationOrphan Drug (US)

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主要目的：PartA：评价 WSD0922-FU 治疗非小细胞肺癌患者中的安全性和耐受性；PartB: 评价 WSD0922-FU 治疗晚期非小细胞肺癌患者的有效性次要目的：PartA：评价 WSD0922-FU 在非小细胞肺癌患者中的药代动力学特征；评价 WSD0922-FU 对非小细胞肺癌患者的初步有效性；PartB:评价 WSD0922-FU 治疗晚期非小细胞肺癌患者中的安全性和初步有效性

[Translation]

Primary objectives: Part A: Evaluate the safety and tolerability of WSD0922-FU in patients with non-small cell lung cancer; Part B: Evaluate the effectiveness of WSD0922-FU in patients with advanced non-small cell lung cancer Secondary objectives: Part A: Evaluate the pharmacokinetic characteristics of WSD0922-FU in patients with non-small cell lung cancer; Evaluate the preliminary effectiveness of WSD0922-FU in patients with non-small cell lung cancer; Part B: Evaluate the safety and preliminary effectiveness of WSD0922-FU in patients with advanced non-small cell lung cancer

Start Date30 Aug 2024

Sponsor / Collaborator

Pharmaron Beijing Co., Ltd.

[+1]

NCT06631989

/ RecruitingPhase 1/2

A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer

This study is a multicenter, open label, single-arm phase I/II clinical study of WSD0922-FU conducted in China, including Part A (dose escalation and expansion study) and Part B (dose extension). To explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance (Osimertinib, Almonertinib, Furmonertinib, Befotertinib).

Start Date21 Aug 2024

Sponsor / Collaborator

Wayshine Biopharm

NCT04197934

/ RecruitingPhase 1IIT

Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of WSD0922-FU

This phase I trial studies the side effects and best dose of WSD0922-FU for the treatment of glioblastoma, anaplastic astrocytoma, or non-small cell lung cancer that has spread to the central nervous system (central nervous system metastases). WSD0922-FU is a targeted treatment which blocks the EGFR protein - a strategy that has led to a lot of benefit in patients with many different cancers. WSD0922-FU may also be able to get into cancers in the brain and spinal cord and help patients with brain and spinal cord cancers.

Start Date20 Dec 2019

Sponsor / Collaborator

Mayo Clinic

[+1]

100 Clinical Results associated with WSD-0922

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100 Translational Medicine associated with WSD-0922

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100 Patents (Medical) associated with WSD-0922

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1

Literatures (Medical) associated with WSD-0922

Neuro-oncology advances

WSD-0922, a novel brain-penetrant inhibitor of epidermal growth factor receptor, promotes survival in glioblastoma mouse models.

Article

Author: Agar, Nathalie Y R ; Baquer, Gerard ; White, Forest M ; Bakken, Katrina K ; Regan, Michael S ; Sun, Claire ; Conage-Pough, Jason E ; Zhang, Jinqiang ; Decker, Paul A ; Mladek, Ann C ; Zhong, Wei ; Tran, Nhan L ; Elmquist, William F ; Oh, Ju-Hee ; Liu, Lily ; Sarkaria, Jann N ; Carlson, Brett L ; Burgenske, Danielle M ; Mu, Zhihua ; Stopka, Sylwia A

BackgroundAlthough the epidermal growth factor receptor (EGFR) is a frequent oncogenic driver in glioblastoma (GBM), efforts to therapeutically target this protein have been largely unsuccessful. The present preclinical study evaluated the novel EGFR inhibitor WSD-0922.MethodsWe employed flank and orthotopic patient-derived xenograft models to characterize WSD-0922 and compare its efficacy to erlotinib, a potent EGFR inhibitor that failed to provide benefit for GBM patients. We performed long-term survival studies and collected short-term tumor, plasma, and whole-brain samples from mice treated with each drug. We utilized mass spectrometry to measure drug concentrations and spatial distribution and to assess the impact of each drug on receptor activity and cellular signaling networks.ResultsWSD-0922 inhibited EGFR signaling as effectively as erlotinib in in vitro and in vivo models. While WSD-0922 was more CNS penetrant than erlotinib in terms of total concentration, comparable concentrations of both drugs were measured at the tumor site in orthotopic models, and the concentration of free WSD-0922 in the brain was significantly less than the concentration of free erlotinib. WSD-0922 treatment provided a clear survival advantage compared to erlotinib in the GBM39 model, with marked suppression of tumor growth and most mice surviving until the end of the study. WSD-0922 treatment preferentially inhibited phosphorylation of several proteins, including those associated with EGFR inhibitor resistance and cell metabolism.ConclusionsWSD-0922 is a highly potent inhibitor of EGFR in GBM, and warrants further evaluation in clinical studies.

100 Deals associated with WSD-0922

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Wayshine Biopharm	30 Aug 2024
EGFR positive non-small cell lung cancer	Phase 2	CN	Wayshine Biopharm	21 Aug 2024
Brain metastases	Phase 1	CN	Wayshine Biopharm	08 Aug 2022
Glioblastoma	Phase 1	-	Vision Biological Technology (Hefei) Co., Ltd.	-
Advanced Malignant Solid Neoplasm	IND Approval	CN	Wayshine Biopharm	08 Jul 2024
EGFR C797S Mutation Non-small Cell Lung Cancer	IND Approval	US	Wayshine Biopharm	27 May 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04197934 (MC1914, SNO2023)	Phase 1	EGFR mutant \| EGFR aberrant \| EGFRvIII mutant	25	WSD0922-Fu 320 mg twice daily	vjhzissasf(kpkqjpdrrh) = Common treatment-related adverse events are comparable to other EGFR inhibitors yynnihklzu (jvidtzmunm ) View more	Positive	10 Nov 2023
NCT04197934 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Astrocytoma \| EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	25	WSD0922	(wghsihcvks) = dkoiyqirau sftnyginqj (rtuzouehym ) View more	Positive	31 May 2023