Delving into the Latest Updates on LiveRNA Therapeutics Inc. with Synapse

Overview

Basic Info

Introduction

LiveRNA Therapeutics Inc. is an innovative mRNA drug research and development enterprise. It was founded in June 2019 and is headquartered in Hengqin New District, Zhuhai. The company focuses on the research and development of innovative products such as mRNA drugs for infectious disease vaccines, tumors, rare diseases, and other protein-deficiency diseases, as well as mRNA cosmetics and anti-aging products. It is committed to promoting the research and industrialization of Chinese mRNA infectious disease vaccines and mRNA products.

Tags

Endocrinology and Metabolic Disease

Infectious Diseases

Other Diseases

Biological products

mRNA vaccine

Prophylactic vaccine

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

Endocrinology and Metabolic Disease	1
Infectious Diseases	1

Top 5 Drug Type	Count

mRNA	1
Biological products	1
mRNA vaccine	1
Prophylactic vaccine	1

Top 5 Target	Count

leptin	1

This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.

Start Date25 Mar 2023

Sponsor / Collaborator

AIM Vaccine Co., Ltd.

[+2]

NCT05599802

/ Unknown statusPhase 1

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)

Start Date01 Feb 2023

Sponsor / Collaborator

AIM Vaccine Co., Ltd.

[+2]

NCT05682638

/ RecruitingPhase 3

A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older

A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older

Start Date30 Jan 2023

Sponsor / Collaborator

AIM Vaccine Co., Ltd.

[+2]

100 Clinical Results associated with LiveRNA Therapeutics Inc.

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0 Patents (Medical) associated with LiveRNA Therapeutics Inc.

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10

Literatures (Medical) associated with LiveRNA Therapeutics Inc.

01 Nov 2023·Vaccine

Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults

Article

Author: Jiang, Guo-Ping ; Dai, Xia-Hong ; Wu, Xiao-Hong ; Wu, Kai-Qi ; Jin, Ting-Han ; Gao, Hai-Nv ; Liu, Qi ; Yu, Xu-Ya ; Luo, Li-Ping ; Pei, Rong-Juan ; Zhong-Chen ; Peng, Yu-Cai ; Shao, Xi ; Shen, Zhen-Wei ; Lou, Dan-Feng ; Li, Lan-Juan ; He, Jian-Xing ; Li, Yu-Hua ; Jiang, Qi ; Huang, Yu-Mei ; Zhang, Fan ; Li, Nan ; Peng, Cong-Gao ; Deng, Fei ; Cao, Fang ; Zhu, Jing-Rui ; Guo, Tong ; Chen, Gui-Ling

BACKGROUNDCOVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in China of an mRNA vaccine (LVRNA009).METHODSIn the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.RESULTSAll these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.CONCLUSIONLVRNA009 has demonstrated promising results in safety and tolerability at all three dose levels among Chinese adults. LVRNA009 at three dose levels could rapidly induce strong humoral and cellular immune responses, including binding and neutralising antibody production and IFN- γ secretion, which showed good immunogenicity.CLINICAL TRIAL REGISTRATION NUMBERClinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.

Biology

Evaluating the Metabolic Basis of α-Gal A mRNA Therapy for Fabry Disease

Article

Author: Deng, Zhiwen ; Hong, Mei ; Li, Shuang ; Liu, Jun ; Liu, Qi ; Peng, Yucai ; Zhang, Zhendong

mRNA injection-based protein supplementation has emerged as a feasible treatment for Fabry disease. However, whether the introduction of LNP-encapsulated mRNA results in the alteration of metabolomics in an in vivo system remains largely unknown. In the present study, α-galactosidase A (α-Gal A) mRNA was generated and injected into the Fabry disease mouse model. The α-Gal A protein was successfully expressed. The level of globotriaosylsphingosine (Lyso-Gb3), a biomarker for Fabry disease, as well as pro-inflammatory cytokines such as nuclear factor kappa-B (NF-κB), interleukin 6 (IL-6), and tumor necrosis factor-α (TNF-α), were greatly decreased compared to the untreated control, indicating the therapeutic outcome of the mRNA drug. Metabolomics analysis found that the level of 20 metabolites was significantly altered in the plasma of mRNA-injected mice. These compounds are primarily enriched in the arachidonic acid metabolism, alanine, aspartate and glutamate metabolism, and glycolysis/gluconeogenesis pathways. Arachidonic acid and 5-hydroxyeicosatetraenoic acid (5-HETE), both of which are important components in the eicosanoid pathway and related to inflammation response, were significantly increased in the injected mice, possibly due to the presence of lipid nanoparticles. Moreover, mRNA can effectively alter the level of metabolites in the amino acid and energy metabolic pathways that are commonly found to be suppressed in Fabry disease. Taken together, the present study demonstrated that in addition to supplementing the deficient α-Gal A protein, the mRNA-based therapeutic agent can also affect levels of metabolites that may help in the recovery of metabolic homeostasis in the full body system.

Zoonoses

Long-Term Protection from SARS-CoV-2 Variants in Mice by a Phase II Clinically Evaluated Original mRNA Vaccine Booster

Author: Yu, Xuya ; Liu, Qi ; Zhang, Fan ; Sun, Jing ; Huang, Yumei ; Luo, Liping ; He, Yiyun ; Guo, Hu ; Peng, Yucai ; Tang, Yanhong ; Zhu, Airu ; Huang, Tao ; Zhao, Jincun ; Dai, Jun ; Zhang, Siyuan ; Liu, Jun

Objective:The global coronavirus disease 2019 (COVID-19) pandemic was caused by SARS-CoV-2. The authors developed an mRNA vaccine (LVRNA009) that encoded the S protein of the Wuhan-Hu-1 strain and evaluated the long-term protection potential against SARS-CoV-2 variants.Methods:Mice were initially vaccinated with 2 doses of LVRNA009, then boosted 8 months later. The virus neutralization titers against SARS-CoV-2 variants and antigen-specific T cell responses of the mice were determined. These animals were also tested using viral challenge experiments. Moreover, a phase II clinical study was carried out in 420 healthy adults.Results:LVRNA009 vaccination induced neutralization antibodies and protected mice from SARS-CoV-2 original and Omicron BA.1.1 challenge 8 months post-boosting. A second booster dose of LVRNA009 further enhanced VNTs against Omicron variants. Clinical studies showed that LVRNA009 has good safety and immunogenicity profiles in humans.Conclusion:LVRNA009 could provide long-term protection against SARS-CoV-2 variants and confer better protection with a booster dose. These findings indicate that LVRNA009, a vaccine designed based on the original virus, might be effective in management of the COVID-19 pandemic.

1

News (Medical) associated with LiveRNA Therapeutics Inc.

01 Jun 2021

·en.aimbio.com

AIM Vaccine completed acquisition of Lifanda to accelerate deployment of mRNA COVID-19 Vaccine

On May 31, AIM Vaccine Co., Ltd completed acquisition of Zhuhai Lifanda Biology Co., Ltd, holding 50.1546% of its shares. Lifanda Biology is one of 3 enterprises obtained clinical approval of mRNA COVID-19 vaccine. Such acquisition serves as the integration between manufacturing enterprise and R&D company, which has accelerated R&D and production layout of AIM Vaccine for mRNA vaccine as well as industrialization of technologies of Lifanda Biology on mRNA. This has promoted production and marketing of mRNA COVID-19 vaccine in China. mRNA COVID-19 vaccine as developed by Lifanda Biology obtained Approval Form of Clinical Trial as approved and issued by National Medical Products Administration in March of this year for formal clinical test as scheduled. Since formal input for R&D of mRNA products in 2017, Lifanda Biology has established its own mRNA production and drug delivery technical platform, and has successfully applied numerous patents of invention for drug design, production and delivery of preparations.

VaccineAcquisitionmRNADrug ApprovalClinical Study

100 Deals associated with LiveRNA Therapeutics Inc.

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100 Translational Medicine associated with LiveRNA Therapeutics Inc.

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Pipeline

Pipeline Snapshot as of 18 May 2025

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

Preclinical

1

IND Application

IND Approval

1

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

LVRNA007	Respiratory Syncytial Virus Infections More	Phase 1
LVRNA101	Herpes Genitalis More	IND Approval
LVRNA015	-	IND Application
Leptin mRNA(LiveRNA Therapeutics) ( leptin )	Leptin Deficiency More	Preclinical