Delving into the Latest Updates on NWRD-08 with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Therapeutic vaccine

Synonyms

NWRD 08, NWRD08

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsUrogenital DiseasesOther Diseases

Active Indication

Squamous Intraepithelial LesionsSquamous Intraepithelial Lesions of the Cervix

Inactive Indication-

Originator Organization

Newish Technology (Beijing) Co., Ltd.

Active Organization

Newish Biotechnology (Wuxi) Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV18.

Start Date11 Nov 2025

Sponsor / Collaborator

Newish Biotechnology (Wuxi) Co., Ltd.

NCT06276101

/ RecruitingPhase 1

Phase I Safety and Tolerability Study of NWRD08 in HPV-16 and/or HPV-18 Related Cervical High-grade Squamous Intraepithelial Lesion (HSIL) Patients

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.

Start Date25 Jan 2024

Sponsor / Collaborator

Newish Technology (Beijing) Co., Ltd.

NCT05905354

/ RecruitingNot Applicable

Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive

This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.

Start Date07 Mar 2022

Sponsor / Collaborator

Newish Technology (Beijing) Co., Ltd.

100 Clinical Results associated with NWRD-08

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100 Translational Medicine associated with NWRD-08

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100 Patents (Medical) associated with NWRD-08

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100 Deals associated with NWRD-08

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Intraepithelial Lesions	Phase 2	China	Newish Biotechnology (Wuxi) Co., Ltd.	11 Nov 2025
Squamous Intraepithelial Lesions of the Cervix	Phase 2	China	Newish Biotechnology (Wuxi) Co., Ltd.	05 Sep 2025