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▎Editor of WuXi AppTec content team July 15, 2021, Vir Biotechnology announced that the Phase 2 MARCH clinical trial in patients with chronic hepatitis B virus (HBV) infection has completed the first patient administration
.
The trial is designed to study the small interfering RNA (siRNA) therapy VIR-2218, the joint effect of neutralizing monoclonal antibody therapy VIR-3434, the aim is to achieve functional cure hepatitis
.
VIR-2218, jointly developed by Vir and Alnylam Pharmaceuticals, is a subcutaneous injection of siRNA therapy that has the potential to stimulate effective immune response and anti-HBV activity
.
VIR-2218 targets the X gene of HBV.
This site allows it to use a single siRNA to inhibit integrated viral DNA (intDNA) and covalently closed circular DNA (cccDNA) expressing hepatitis B virus surface antigen (HBsAg)
.
It uses enhanced stabilization chemical plus (ESC+) technology to enhance metabolic stability, while reducing the off-target effect of siRNA, thereby reducing the toxic side effects of therapy
.
The clinical trial data currently obtained show that it can significantly reduce the level of hepatitis B surface antigen in patients and is expected to bring functional cure
.
▲Introduction to VIR-2218 (picture source: Reference [3]) VIR-3434 is a subcutaneous administration of HBV neutralizing monoclonal antibody therapy, which aims to block all 10 genotypes of HBV from entering liver cells and reduce The level of viral particles and subviral particles in the blood
.
It not only inhibits the entry of HBV into cells, but also helps to clear HBsAg
.
The clinical data obtained before shows that VIR-3434 can quickly reduce the patient's HBsAg level at very low doses
.
The special optimization of the Fc terminal of this antibody allows it to bind to activating Fc receptors (FcRs) on dendritic cells (DC) responsible for antigen presentation to promote the maturation and antigen presentation of DC cells, thereby stimulating effector T cell responses
.
This gives VIR-3434 the potential to become a therapeutic vaccine
.
▲The modification of the Fc-terminus of the neutralizing antibody gives VIR-3434 the potential to become a therapeutic vaccine (picture source: reference [4]) This multi-center, open-label phase 2 trial aims to evaluate about 90 patients receiving nucleosides In patients with chronic hepatitis B (18-65 years old) treated with reverse transcriptase inhibitors, the safety, tolerability and efficacy of the combined treatment of VIR-2218 and VIR-3434
.
In the trial, VIR-2218 and VIR-3434 will be administered by subcutaneous injection at different dose levels.
The treatment period is 4-20 weeks, and the follow-up period is up to 116 weeks, depending on the administration cohort
.
The primary endpoint of the trial is the proportion of patients with adverse events and serious adverse events after treatment; the classification of laboratory test indicators after treatment; and the proportion of patients with functional cure (defined as undetectable HBsAg and HBV DNA sustained suppression)
.
"With severe morbidity and mortality, HBV infection remains an urgent global public health challenge
.
We believe that a combination therapy focused on immune recovery will be the key to achieving a functional cure
.
" Vir's Chief Medical Officer Dr.
Phil Pang stated, "We are excited about the potential of VIR-2218 as the cornerstone of this method
.
In addition, in the ongoing phase 1 trial, VIR-3434 has demonstrated its ability to significantly reduce hepatitis B surface antigen at low doses
.
And most importantly, VIR-3434 has the potential to become a therapeutic T cell vaccine
.
We believe that the VIR-2218 in combination with VIR-3434, will change the current treatment of hepatitis B pattern
.
"Reference: [1] Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic Hepatitis B Virus Infection.
Retrieved July 15, 2021, from https://investors.
vir.
bio/news-releases/news-release-details/vir-biotechnology-initiates-phase-2-clinical-trial-evaluating[2] Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic Hepatitis B Virus Infection.
Retrieved July 15, 2021, from https://finance.
yahoo.
com/news/vir-biotechnology-initiates-phase-2-123000780.
html[3] Safety and Antiviral Activity of VIR-2218, An X-Targeting RNAi Therapeutic, In Participants With Chronic Hepatitis B Infection: Week 48 Follow-Up Results.
Retrieved June 25, 2021, from https://investors.
vir.
bio/static-files/435251ac-661c-46a0-90a6-c5dd163235b2[4] A Phase 1 Study Evaluating the Neutralizing, Vaccinal Monoclonal Antibody VIR-3434 in Participants With Chronic Hepatitis B Virus Infection: Preliminary Results.
Retrieved June 25, 2021, from https://investors.
vir.
bio/static-files/19f65691-4133-41e9-b4eb-d3ad5a4045ba Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
The trial is designed to study the small interfering RNA (siRNA) therapy VIR-2218, the joint effect of neutralizing monoclonal antibody therapy VIR-3434, the aim is to achieve functional cure hepatitis
.
VIR-2218, jointly developed by Vir and Alnylam Pharmaceuticals, is a subcutaneous injection of siRNA therapy that has the potential to stimulate effective immune response and anti-HBV activity
.
VIR-2218 targets the X gene of HBV.
This site allows it to use a single siRNA to inhibit integrated viral DNA (intDNA) and covalently closed circular DNA (cccDNA) expressing hepatitis B virus surface antigen (HBsAg)
.
It uses enhanced stabilization chemical plus (ESC+) technology to enhance metabolic stability, while reducing the off-target effect of siRNA, thereby reducing the toxic side effects of therapy
.
The clinical trial data currently obtained show that it can significantly reduce the level of hepatitis B surface antigen in patients and is expected to bring functional cure
.
▲Introduction to VIR-2218 (picture source: Reference [3]) VIR-3434 is a subcutaneous administration of HBV neutralizing monoclonal antibody therapy, which aims to block all 10 genotypes of HBV from entering liver cells and reduce The level of viral particles and subviral particles in the blood
.
It not only inhibits the entry of HBV into cells, but also helps to clear HBsAg
.
The clinical data obtained before shows that VIR-3434 can quickly reduce the patient's HBsAg level at very low doses
.
The special optimization of the Fc terminal of this antibody allows it to bind to activating Fc receptors (FcRs) on dendritic cells (DC) responsible for antigen presentation to promote the maturation and antigen presentation of DC cells, thereby stimulating effector T cell responses
.
This gives VIR-3434 the potential to become a therapeutic vaccine
.
▲The modification of the Fc-terminus of the neutralizing antibody gives VIR-3434 the potential to become a therapeutic vaccine (picture source: reference [4]) This multi-center, open-label phase 2 trial aims to evaluate about 90 patients receiving nucleosides In patients with chronic hepatitis B (18-65 years old) treated with reverse transcriptase inhibitors, the safety, tolerability and efficacy of the combined treatment of VIR-2218 and VIR-3434
.
In the trial, VIR-2218 and VIR-3434 will be administered by subcutaneous injection at different dose levels.
The treatment period is 4-20 weeks, and the follow-up period is up to 116 weeks, depending on the administration cohort
.
The primary endpoint of the trial is the proportion of patients with adverse events and serious adverse events after treatment; the classification of laboratory test indicators after treatment; and the proportion of patients with functional cure (defined as undetectable HBsAg and HBV DNA sustained suppression)
.
"With severe morbidity and mortality, HBV infection remains an urgent global public health challenge
.
We believe that a combination therapy focused on immune recovery will be the key to achieving a functional cure
.
" Vir's Chief Medical Officer Dr.
Phil Pang stated, "We are excited about the potential of VIR-2218 as the cornerstone of this method
.
In addition, in the ongoing phase 1 trial, VIR-3434 has demonstrated its ability to significantly reduce hepatitis B surface antigen at low doses
.
And most importantly, VIR-3434 has the potential to become a therapeutic T cell vaccine
.
We believe that the VIR-2218 in combination with VIR-3434, will change the current treatment of hepatitis B pattern
.
"Reference: [1] Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic Hepatitis B Virus Infection.
Retrieved July 15, 2021, from https://investors.
vir.
bio/news-releases/news-release-details/vir-biotechnology-initiates-phase-2-clinical-trial-evaluating[2] Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic Hepatitis B Virus Infection.
Retrieved July 15, 2021, from https://finance.
yahoo.
com/news/vir-biotechnology-initiates-phase-2-123000780.
html[3] Safety and Antiviral Activity of VIR-2218, An X-Targeting RNAi Therapeutic, In Participants With Chronic Hepatitis B Infection: Week 48 Follow-Up Results.
Retrieved June 25, 2021, from https://investors.
vir.
bio/static-files/435251ac-661c-46a0-90a6-c5dd163235b2[4] A Phase 1 Study Evaluating the Neutralizing, Vaccinal Monoclonal Antibody VIR-3434 in Participants With Chronic Hepatitis B Virus Infection: Preliminary Results.
Retrieved June 25, 2021, from https://investors.
vir.
bio/static-files/19f65691-4133-41e9-b4eb-d3ad5a4045ba Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
