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March 30, 2022/eMedClub News/--Recently, AlloVir, which focuses on allogeneic T-cell immunotherapy, announced the initiation of a global Phase 3 registrational study of posoleucel
.
Posoleucel is an allogeneic, off-the-shelf, multi-virus-specific T-cell (VST) therapy for the prevention of adenovirus (AdV), BK Clinically significant infections and infections caused by six potentially life-threatening viruses including cytomegalovirus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV) end-organ disease
.
This global, multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 300 adult and pediatric patients and will assess clinically significant infection or onset of end-organ disease by the primary endpoint of a 14-week dosing interval quantity
.
Safety and efficacy assessments will continue to be tracked through Week 26
.
By preventing life-threatening viral diseases and infections, Posoleucel has the potential to fundamentally change the treatment landscape for allo-HCT, either as a prophylactic treatment for high-risk patients or as one of six viruses that have been activated to target posoleucel Early priority treatment for patients with multiple viruses
.
As 90% of allo-HCT patients have at least one of these viruses activated, there is a huge market opportunity globally for the prevention of devastating viral diseases
.
Preliminary data from a Phase 2 study presented at the 2021 American Society of Hematology (ASH) Annual Meeting support the use of posoleucel to prevent life-threatening infections from six common viruses following allo-HCT
.
In an oral presentation at the 48th European Society of Blood and Marrow Transplantation (EBMT) annual meeting in 2022, AlloVir shared an update to the dataset, which includes more patients and longer follow-up
.
In the ongoing Phase 2 trial, 26 patients received at least one dose of posoleucel, including those who completed, discontinued, or continued posoleucel, with only 3 patients at week 14 as of the data cutoff for this analysis Clinically significant infection was observed
.
Of the 24 patients who reached the primary endpoint at Week 14, 21 patients had no clinically significant infection
.
And repeated dosing was well tolerated
.
Final results from the Phase 2 study are expected by the end of this year
.
VST Therapy for Viral Infection T cells are critical to the ability of the immune system to detect and kill virus-infected cells
.
In healthy people, virus-specific T cells are a key component of the body's natural defense system, protecting against thousands of disease-causing viruses
.
However, these viruses are not suppressed in immunocompromised patients, such as those undergoing hematopoietic cell transplantation (HCT), solid organ transplantation (SOT) and cancer treatment, HIV-infected patients, and the elderly
.
Often, when viruses attack immunocompromised patients, standard treatments do not address the underlying problem with a weakened immune system, and as a result, many patients suffer life-threatening consequences such as multiple organ damage and failure, and even death
.
VST therapy is a type of T cell produced specifically from a viral infection that has the ability to recognize and kill infected cells while simultaneously activating the immune system in the rest of the body
.
The VST therapy developed by AlloVir works by isolating allogeneic (healthy donor) T cells, exposing them to a harmless fragment of the target virus (which does not produce virus, but stimulates T cells), and then uses Innate immune proteins called cytokines perform immune stimulation, moving them from a resting state into an activated state, turning on their virus-specific immune functions and expanding them
.
▲ Virus-specific T cell activation and mechanism of action (Image source: AlloVir official website) AlloVir aims to develop this VST therapy in order to target a variety of pathogenic viruses
.
It is worth mentioning that this type of therapy can store a large amount of expanded VST by cryopreservation, and give relevant therapy when the patient needs to treat or prevent the disease
.
This method can not only industrialize the therapy, but also greatly reduce the manufacturing cost
.
▲ AlloVir's VST therapy pipeline (Image source: AlloVir's official website) The company's second allogeneic, off-the-shelf multivirus-specific T-cell therapy is ALVR106, which targets 4 acquired respiratory viruses: respiratory syncytial virus, influenza Viruses, parainfluenza viruses and human pneumoviruses
.
The IND application for ALVR106 has been approved in 2020
.
In addition, AlloVir and Baylor College of Medicine (BCM) have jointly developed an allogeneic, off-the-shelf, virus-specific T-cell therapy ALVR109 for high-risk patients with Covid-19, designed to eliminate 2019-nCoV-infected cells.
Stop disease progression
.
In September 2020, the US FDA has approved the IND application for ALVR109 for the treatment of patients with severe new coronary pneumonia (COVID-19) due to SARS-CoV-2, which is currently being evaluated in a Phase 1 study (NCT04401410)
.
VST therapy for tumors VST can recognize viral antigens located on the surface of tumors.
After infusion of VST, it migrates to the tumor site and binds to viral antigens, thereby releasing cytotoxic particles that destroy cancer cells
.
Compared with ordinary CAR-T, VST therapy has a significant therapeutic effect on solid tumors and can play a longer-term protective effect
.
Based on the anti-cancer potential of VST, T cell therapy has been developed to specifically target virus-related cancers.
In addition to being used as a monotherapy, it can also be combined with CAR targeting technology and the cell lysis ability of oncolytic viruses to play a greater role.
anticancer efficacy
.
Kite's KITE-439, a TCR therapy targeting the E7 protein, is used to treat HPV-16-related cancers
.
Early data from the Phase 1 trial showed that KITE-439 could achieve partial tumor remission in some HPV-16-positive cancer patients, initially showing good safety and efficacy
.
Recommended reading: Phase 1 clinical trial of Kite's virus-specific TCR-T therapy launched in City of Hope, aiming at targeting HPV-related relapsed/refractory cancer | Chemically engineered autologous T cell products expressing hepatitis B virus (HBV)-specific T cell receptor (TCR)
.
LioCyx-M004 has demonstrated good safety and significant improvement in patient survival in early phase 1 studies.
In September 2021, the product received the FDA's IND approval to conduct a phase b/2 international multicenter clinical study
.
In December 2021, LioCyx-M004 was granted Fast Track designation by the US FDA
.
Recommended reading: Lyon Biotech Receives FDA Fast Track Designation: Application of HBV-Specific TCR-T for Hepatocellular Carcinoma Tessa's Allogeneic CD30-CAR Epstein-Bar Virus-Specific T-Cell Therapy (CD30-CAR EBVST) Combined with VST and the unique properties of CAR, aimed at developing established cell therapies for the treatment of hematological malignancies and solid tumors
.
In early trials, allogeneic VST without any form of genetic modification has been shown to have a favorable safety profile and efficacy, along with a low risk of transplant rejection and other serious reactions associated with current allogeneic cell therapy
.
Currently, Tessa is conducting a Phase 1 clinical trial of EBVST in the United States in collaboration with Baylor College of Medicine (NCT04288726)
.
Recommended reading: CD30 CAR-T enters the late clinical development stage, let’s talk about the development direction of Tessa’s various CAR therapies Safety, further research will gradually improve the treatment strategy of this therapy, so as to bring better treatment plans for patients
.
References: 1.
https:// -from-six-common-viruses-in-high-risk-allogeneic-hematopoietic-cell-transplant-patients/2.
https:// ——List of recent popular events——▼March 29 , Development Analysis and Process Development of Nucleic Acid Drugs Industry ▼On March 31, BioTalk Innovative Biopharmaceutical Series Lectures | Helping Gene Therapy - Authoritative Interpretation of Characterization Analysis of AAV Gene Therapy Drugs▼ On March 31, Guangzhou, the development of viral delivery vector AAV Quality Control Challenge Theme Salon▼July 1-3, Shanghai, 2022 Shanghai International Bio-Innovative Drug Industry Expo
.
Posoleucel is an allogeneic, off-the-shelf, multi-virus-specific T-cell (VST) therapy for the prevention of adenovirus (AdV), BK Clinically significant infections and infections caused by six potentially life-threatening viruses including cytomegalovirus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV) end-organ disease
.
This global, multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 300 adult and pediatric patients and will assess clinically significant infection or onset of end-organ disease by the primary endpoint of a 14-week dosing interval quantity
.
Safety and efficacy assessments will continue to be tracked through Week 26
.
By preventing life-threatening viral diseases and infections, Posoleucel has the potential to fundamentally change the treatment landscape for allo-HCT, either as a prophylactic treatment for high-risk patients or as one of six viruses that have been activated to target posoleucel Early priority treatment for patients with multiple viruses
.
As 90% of allo-HCT patients have at least one of these viruses activated, there is a huge market opportunity globally for the prevention of devastating viral diseases
.
Preliminary data from a Phase 2 study presented at the 2021 American Society of Hematology (ASH) Annual Meeting support the use of posoleucel to prevent life-threatening infections from six common viruses following allo-HCT
.
In an oral presentation at the 48th European Society of Blood and Marrow Transplantation (EBMT) annual meeting in 2022, AlloVir shared an update to the dataset, which includes more patients and longer follow-up
.
In the ongoing Phase 2 trial, 26 patients received at least one dose of posoleucel, including those who completed, discontinued, or continued posoleucel, with only 3 patients at week 14 as of the data cutoff for this analysis Clinically significant infection was observed
.
Of the 24 patients who reached the primary endpoint at Week 14, 21 patients had no clinically significant infection
.
And repeated dosing was well tolerated
.
Final results from the Phase 2 study are expected by the end of this year
.
VST Therapy for Viral Infection T cells are critical to the ability of the immune system to detect and kill virus-infected cells
.
In healthy people, virus-specific T cells are a key component of the body's natural defense system, protecting against thousands of disease-causing viruses
.
However, these viruses are not suppressed in immunocompromised patients, such as those undergoing hematopoietic cell transplantation (HCT), solid organ transplantation (SOT) and cancer treatment, HIV-infected patients, and the elderly
.
Often, when viruses attack immunocompromised patients, standard treatments do not address the underlying problem with a weakened immune system, and as a result, many patients suffer life-threatening consequences such as multiple organ damage and failure, and even death
.
VST therapy is a type of T cell produced specifically from a viral infection that has the ability to recognize and kill infected cells while simultaneously activating the immune system in the rest of the body
.
The VST therapy developed by AlloVir works by isolating allogeneic (healthy donor) T cells, exposing them to a harmless fragment of the target virus (which does not produce virus, but stimulates T cells), and then uses Innate immune proteins called cytokines perform immune stimulation, moving them from a resting state into an activated state, turning on their virus-specific immune functions and expanding them
.
▲ Virus-specific T cell activation and mechanism of action (Image source: AlloVir official website) AlloVir aims to develop this VST therapy in order to target a variety of pathogenic viruses
.
It is worth mentioning that this type of therapy can store a large amount of expanded VST by cryopreservation, and give relevant therapy when the patient needs to treat or prevent the disease
.
This method can not only industrialize the therapy, but also greatly reduce the manufacturing cost
.
▲ AlloVir's VST therapy pipeline (Image source: AlloVir's official website) The company's second allogeneic, off-the-shelf multivirus-specific T-cell therapy is ALVR106, which targets 4 acquired respiratory viruses: respiratory syncytial virus, influenza Viruses, parainfluenza viruses and human pneumoviruses
.
The IND application for ALVR106 has been approved in 2020
.
In addition, AlloVir and Baylor College of Medicine (BCM) have jointly developed an allogeneic, off-the-shelf, virus-specific T-cell therapy ALVR109 for high-risk patients with Covid-19, designed to eliminate 2019-nCoV-infected cells.
Stop disease progression
.
In September 2020, the US FDA has approved the IND application for ALVR109 for the treatment of patients with severe new coronary pneumonia (COVID-19) due to SARS-CoV-2, which is currently being evaluated in a Phase 1 study (NCT04401410)
.
VST therapy for tumors VST can recognize viral antigens located on the surface of tumors.
After infusion of VST, it migrates to the tumor site and binds to viral antigens, thereby releasing cytotoxic particles that destroy cancer cells
.
Compared with ordinary CAR-T, VST therapy has a significant therapeutic effect on solid tumors and can play a longer-term protective effect
.
Based on the anti-cancer potential of VST, T cell therapy has been developed to specifically target virus-related cancers.
In addition to being used as a monotherapy, it can also be combined with CAR targeting technology and the cell lysis ability of oncolytic viruses to play a greater role.
anticancer efficacy
.
Kite's KITE-439, a TCR therapy targeting the E7 protein, is used to treat HPV-16-related cancers
.
Early data from the Phase 1 trial showed that KITE-439 could achieve partial tumor remission in some HPV-16-positive cancer patients, initially showing good safety and efficacy
.
Recommended reading: Phase 1 clinical trial of Kite's virus-specific TCR-T therapy launched in City of Hope, aiming at targeting HPV-related relapsed/refractory cancer | Chemically engineered autologous T cell products expressing hepatitis B virus (HBV)-specific T cell receptor (TCR)
.
LioCyx-M004 has demonstrated good safety and significant improvement in patient survival in early phase 1 studies.
In September 2021, the product received the FDA's IND approval to conduct a phase b/2 international multicenter clinical study
.
In December 2021, LioCyx-M004 was granted Fast Track designation by the US FDA
.
Recommended reading: Lyon Biotech Receives FDA Fast Track Designation: Application of HBV-Specific TCR-T for Hepatocellular Carcinoma Tessa's Allogeneic CD30-CAR Epstein-Bar Virus-Specific T-Cell Therapy (CD30-CAR EBVST) Combined with VST and the unique properties of CAR, aimed at developing established cell therapies for the treatment of hematological malignancies and solid tumors
.
In early trials, allogeneic VST without any form of genetic modification has been shown to have a favorable safety profile and efficacy, along with a low risk of transplant rejection and other serious reactions associated with current allogeneic cell therapy
.
Currently, Tessa is conducting a Phase 1 clinical trial of EBVST in the United States in collaboration with Baylor College of Medicine (NCT04288726)
.
Recommended reading: CD30 CAR-T enters the late clinical development stage, let’s talk about the development direction of Tessa’s various CAR therapies Safety, further research will gradually improve the treatment strategy of this therapy, so as to bring better treatment plans for patients
.
References: 1.
https:// -from-six-common-viruses-in-high-risk-allogeneic-hematopoietic-cell-transplant-patients/2.
https:// ——List of recent popular events——▼March 29 , Development Analysis and Process Development of Nucleic Acid Drugs Industry ▼On March 31, BioTalk Innovative Biopharmaceutical Series Lectures | Helping Gene Therapy - Authoritative Interpretation of Characterization Analysis of AAV Gene Therapy Drugs▼ On March 31, Guangzhou, the development of viral delivery vector AAV Quality Control Challenge Theme Salon▼July 1-3, Shanghai, 2022 Shanghai International Bio-Innovative Drug Industry Expo
