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▎Brii Biosciences, VIR Biotechnology, and VBI Vaccines, editors of WuXi AppTec's content team, announced today that the Phase 2 clinical trial for the treatment of chronic hepatitis B virus (HBV) infection has completed the first patient administration.
The press release pointed out that this is the first clinical trial that combines two anti-hepatitis B drugs with different mechanisms of action to "functionally cure" hepatitis B.
It will evaluate the safety and effectiveness of BRII-835 (VIR-2218), a candidate siRNA therapy that inhibits HBV protein expression, in combination with the research HBV immunotherapy BRII-179 (VBI-2601), combined with interferon adjuvant therapy.
With the support of VIR Biotechnology and VBI, Tengshengbo Pharmaceutical will lead the design and implementation of this functional cure proof-of-concept study.
The trials will be conducted in countries such as Australia, China, South Korea, New Zealand, Singapore and Thailand.
Dr.
Francisco Diaz-Mitoma, Chief Medical Officer of VBI, said: “We believe that a functional cure for HBV is possible.
In addition to suppressing the virus, it is also necessary to restore HBV-specific immune control.
Our previous research data shows that BRII-179 (VBI- 2601) can re-regulate the specific response of antibodies and T cells to hepatitis B virus.
This trial combines a therapeutic HBV vaccine with antiviral drugs designed to reduce the level of HBV surface antigens for the first time to restore immunity against HBV.
We Looking forward to the results of the trial, this is a milestone.
"1.
China is a major hepatitis B country.
Hepatitis B is one of the most significant infectious disease threats in the world, with more than 290 million people infected worldwide.Hepatitis B virus infection is the main cause of liver disease, and current treatment methods are difficult to cure, and many patients will develop secondary liver cancer.
Every year, about 900,000 people die from complications of chronic hepatitis B virus, such as liver decompensation and hepatocellular carcinoma.
According to WHO statistics, one third of chronic hepatitis B virus infections worldwide are in China.
Currently, China has an estimated 90 million patients with chronic hepatitis B, of which 28 million need treatment, and 7 million need emergency treatment due to the risk of severe liver disease and cancer.
2.
What is BRII-835 (VIR-2218)? BRII-835 (VIR-2218) is an investigational subcutaneous injection of siRNA targeting HBV, which has the potential to stimulate effective immune response and anti-HBV activity.
It uses Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance metabolic stability while minimizing the off-target activity of sequence matching, which may increase the therapeutic index.
The Phase 2 clinical trial data released last year showed that it can significantly reduce the level of hepatitis B surface antigen (HBsAg) in patients.
▲VIR-2218 significantly reduces the level of hepatitis B surface antigen in patients (the black arrow indicates the administration time of siRNA therapy, picture source: EASL official website) 3.
What is BRII-179 (VBI-2601)? BRII-179 (VBI-2601) is an innovative HBV immunotherapy based on recombinant protein.
Its design is a VBI-based preventive HBV vaccine candidate, aimed at enhancing the immunity of B cells and T cells.
The results of a phase 1a/2a clinical trial published a few days ago showed that it stimulated a T cell immune response against HBV surface antigen in more than 50% of patients.
4.
Why build a combination therapy? In a previous interview with WuXi AppTec's content team, Dr.
Hong Zhi, President and CEO of Tengshengbo Pharmaceutical, gave an easy-to-understand explanation: “The reason why hepatitis B is difficult to cure is because hepatitis B virus produces a large amount of hepatitis B virus.
Circulating surface antigens, and some other proteins. Everyone believes that these hepatitis B virus products are immunosuppressive, making the immune system unable to control viral infections well.
So the first step is to suppress the products of these viruses and first reduce their levels to relieve immunosuppression.
This is like driving a car, you first need to release the brakes, and then hope that the immune system can reshape the anti-viral response.
"It is not enough to relieve immunosuppression, so the second step requires some immune regulation.
There are
basically two types of regulation.
One is for the innate immune system, such as interferon, and for example, the recent collaboration between Vir Biotechnology and Gilead Sciences.
BRII-835 (VIR-2218), these are all regulating the innate immune system.
▲Dr.
Hong Zhi, President and CEO of Tengshengbo Pharmaceutical (Image source: Tengshengbo Pharmaceutical official website) "Other work focuses on the adaptive immune system, inducing production Adaptive immunity means activating T cells and B cells.
For example, the therapeutic vaccine BRII-835 (VBI-2601) that we cooperated with VBI is based on this principle.
At present, the general direction of functional cure for hepatitis B is in these two aspects: firstly relieve immunosuppression, and then induce immune response.
The induced immune response can be innate or adaptive.
Let's use a driving analogy.
Release the brake first, and then step on the accelerator to drive the car forward.
Just release the brakes and don't step on the accelerator, the car may not move.
"Persistent clearance of HBV surface antigen in the serum, also known as functional cure, rarely occurs in the natural history of HBV infection or the current standard treatment.
We believe that whether BRII-835 (VIR-2218) is used to reduce the expression of viral antigens or BRII-179 (VBI-2601) is used to continuously induce HBV-specific host immune responses, it can eliminate viral immunosuppression and subsequently destroy immune tolerance.
Subject to.
The combined use of these two drugs is a step towards the development of a functional cure for hepatitis B.
sn=031c89babf96778b46998a3083db97da 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 press release pointed out that this is the first clinical trial that combines two anti-hepatitis B drugs with different mechanisms of action to "functionally cure" hepatitis B.
It will evaluate the safety and effectiveness of BRII-835 (VIR-2218), a candidate siRNA therapy that inhibits HBV protein expression, in combination with the research HBV immunotherapy BRII-179 (VBI-2601), combined with interferon adjuvant therapy.
With the support of VIR Biotechnology and VBI, Tengshengbo Pharmaceutical will lead the design and implementation of this functional cure proof-of-concept study.
The trials will be conducted in countries such as Australia, China, South Korea, New Zealand, Singapore and Thailand.
Dr.
Francisco Diaz-Mitoma, Chief Medical Officer of VBI, said: “We believe that a functional cure for HBV is possible.
In addition to suppressing the virus, it is also necessary to restore HBV-specific immune control.
Our previous research data shows that BRII-179 (VBI- 2601) can re-regulate the specific response of antibodies and T cells to hepatitis B virus.
This trial combines a therapeutic HBV vaccine with antiviral drugs designed to reduce the level of HBV surface antigens for the first time to restore immunity against HBV.
We Looking forward to the results of the trial, this is a milestone.
"1.
China is a major hepatitis B country.
Hepatitis B is one of the most significant infectious disease threats in the world, with more than 290 million people infected worldwide.Hepatitis B virus infection is the main cause of liver disease, and current treatment methods are difficult to cure, and many patients will develop secondary liver cancer.
Every year, about 900,000 people die from complications of chronic hepatitis B virus, such as liver decompensation and hepatocellular carcinoma.
According to WHO statistics, one third of chronic hepatitis B virus infections worldwide are in China.
Currently, China has an estimated 90 million patients with chronic hepatitis B, of which 28 million need treatment, and 7 million need emergency treatment due to the risk of severe liver disease and cancer.
2.
What is BRII-835 (VIR-2218)? BRII-835 (VIR-2218) is an investigational subcutaneous injection of siRNA targeting HBV, which has the potential to stimulate effective immune response and anti-HBV activity.
It uses Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance metabolic stability while minimizing the off-target activity of sequence matching, which may increase the therapeutic index.
The Phase 2 clinical trial data released last year showed that it can significantly reduce the level of hepatitis B surface antigen (HBsAg) in patients.
▲VIR-2218 significantly reduces the level of hepatitis B surface antigen in patients (the black arrow indicates the administration time of siRNA therapy, picture source: EASL official website) 3.
What is BRII-179 (VBI-2601)? BRII-179 (VBI-2601) is an innovative HBV immunotherapy based on recombinant protein.
Its design is a VBI-based preventive HBV vaccine candidate, aimed at enhancing the immunity of B cells and T cells.
The results of a phase 1a/2a clinical trial published a few days ago showed that it stimulated a T cell immune response against HBV surface antigen in more than 50% of patients.
4.
Why build a combination therapy? In a previous interview with WuXi AppTec's content team, Dr.
Hong Zhi, President and CEO of Tengshengbo Pharmaceutical, gave an easy-to-understand explanation: “The reason why hepatitis B is difficult to cure is because hepatitis B virus produces a large amount of hepatitis B virus.
Circulating surface antigens, and some other proteins. Everyone believes that these hepatitis B virus products are immunosuppressive, making the immune system unable to control viral infections well.
So the first step is to suppress the products of these viruses and first reduce their levels to relieve immunosuppression.
This is like driving a car, you first need to release the brakes, and then hope that the immune system can reshape the anti-viral response.
"It is not enough to relieve immunosuppression, so the second step requires some immune regulation.
There are
basically two types of regulation.
One is for the innate immune system, such as interferon, and for example, the recent collaboration between Vir Biotechnology and Gilead Sciences.
BRII-835 (VIR-2218), these are all regulating the innate immune system.
▲Dr.
Hong Zhi, President and CEO of Tengshengbo Pharmaceutical (Image source: Tengshengbo Pharmaceutical official website) "Other work focuses on the adaptive immune system, inducing production Adaptive immunity means activating T cells and B cells.
For example, the therapeutic vaccine BRII-835 (VBI-2601) that we cooperated with VBI is based on this principle.
At present, the general direction of functional cure for hepatitis B is in these two aspects: firstly relieve immunosuppression, and then induce immune response.
The induced immune response can be innate or adaptive.
Let's use a driving analogy.
Release the brake first, and then step on the accelerator to drive the car forward.
Just release the brakes and don't step on the accelerator, the car may not move.
"Persistent clearance of HBV surface antigen in the serum, also known as functional cure, rarely occurs in the natural history of HBV infection or the current standard treatment.
We believe that whether BRII-835 (VIR-2218) is used to reduce the expression of viral antigens or BRII-179 (VBI-2601) is used to continuously induce HBV-specific host immune responses, it can eliminate viral immunosuppression and subsequently destroy immune tolerance.
Subject to.
The combined use of these two drugs is a step towards the development of a functional cure for hepatitis B.
sn=031c89babf96778b46998a3083db97da 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.
