-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Recent popular reports by Yimike ★ The article elaborates: CAR-T production whole-process solution combing ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? MedClub News June 3, 2021/MedClub News/--On May 27, 2021, American Gene Technologies (AGT), a clinical-stage biotechnology company, announced that its phase I clinical trial has completed its first patient medicine.
The clinical trial aims to evaluate the safety of AGT103-T, a cellular gene therapy product.
In this trial, named RePAIR (NCT04561258), participants were injected with their own CD4 T cells at a time, which are rich in cells that can respond to HIV and undergo genetic modification to fight infection.
On May 19, the Washington Institute of Health in Washington, D.
C.
completed the first infusion.
AGT103-T is a genetically modified cell product made from the body's own cells, rich in CD4 T cells with HIV specificity and resistance.
The AGT method is unique in that it is dedicated to repairing the critical immune system damage caused by HIV.
HIV infects the human body to cause this specific damage, which means that the T helper cells needed for immunization against HIV are also killed, so the infected person will not be able to eliminate HIV through their own immune system and become chronically infected.
The AGT method aims to repair T helper cell defects and provide durable virus control.
Even if the sequence of the HIV strain changes, or the path to enter and infect T cells is changed, the virus control provided by the AGT treatment method will not be affected.
AGT's HIV treatment drug AGT103-T, as an HIV treatment drug launched by AGT, can remove infected cells in the body and reduce or eliminate the need for lifelong antiretroviral therapy.
As early as October 2019, AGT announced the submission of an IND application to the FDA for its HIV project.
In August 2020, the FDA approved AGT to advance the Phase 1 clinical trial of its HIV treatment program.
The first patient confirmed to participate in the trial on October 12, 2020, marking the actual start of the study.
In the same month, patients underwent leukopak (immune cell blood draw), based on which AGT carried out their proprietary process in gene therapy, and carried out more than 70 days of large-scale product quality control.
The Data and Safety Monitoring Board (DSMB) will evaluate the safety data of the first participating patient in July 2021 and determine whether the study can continue.
AGT expects to complete the main content in June 2022, and the entire study is expected to end in September 2022.
Chief Scientific Officer Dr.
C.
David Pauza said: “The first treatment of individuals with our product is an important step forward and the culmination of the design, development, manufacturing and approval of this product in human testing.
We It is believed that this therapy can change the human body’s ability to fight HIV, and the research of the first human trial also marks that we have a better understanding of what results this innovative therapy can achieve.
"This is the first time AGT103-T has been applied to the human body.
the study.
The primary end point of this study is to evaluate the safety of AGT103-T in HIV test patients receiving antiretroviral therapy and well-controlled viremia; tests related to the secondary end point are used to assess the participant’s response to the treatment.
Including changes in the immune response to HIV.
This safety study will follow up participants treated with AGT103-T for 6 months, and then participate in the 15-year long-term follow-up required for all gene therapy trials prescribed by the FDA.
The study is divided into a low-dose cohort and a high-dose cohort.
It is expected that the number of participants in the trial will be 6 and a parallel grouping trial will be conducted.
The number of transgenic T cells in a single infusion in the low-dose cohort was between 1x10e8 and 1x10e9, while the number of cells in a single infusion in the high-dose cohort was between 1x10e9 and 5x10e9.
In the treatment of AGT, the number of HIV-specific immune cells protected and returned to the participants will be nearly 2,000 times the number reached in the previous clinical trial of Sangamo Therapeutics Biopharmaceutical Co.
, Ltd.
In the previous trial, the patient's response rate was only 10%.
The AGT data has been replicated in NIH Research Institute NIAID, the world's top HIV laboratory, verifying that the therapy has significant efficacy and prospects for curing HIV.
CEO Jeff Galvin said: "This project represents an important step forward in the effectiveness of this method.
In the HIV therapeutic community, this method has significant theoretical and empirical momentum.
" He continued.
"Now that we have seen some evidence that patients are tolerant to the treatment, I believe that we will soon see signs of efficacy, which will convince the scientific community that the cure for HIV has been achieved or is very close.
I
I am extremely happy and proud of the team.
I am extremely optimistic about the future of this cell therapy and the ultimate contribution of AGT to HIV treatment.
"The traditional treatment of AIDS HIV (HIV) infection is a global one.
The epidemic has spread to more than 200 countries and regions, and the total number of infected people exceeds 60 million.
About one-third of new infections occur in people aged 15-24.
With the development of medicine, AIDS has gone from incurable to preventable and controllable.
In 1996, Chinese-American scientist He Dayi proposed the "cocktail" therapy, which immediately reduced the AIDS-related mortality rate at that time by 60%-80%.
It has now become the traditional mainstream AIDS treatment method. The so-called "cocktail" therapy refers to high-efficiency antiretroviral therapy (HAART), which uses three or more mixed drugs, such as antiviral protease drugs, antiviral reverse transcription drugs, etc.
, to target HIV infection in humans.
Combining drugs in different links can inhibit virus replication at a low level.
Nowadays, AIDS treatment drugs can be divided into six categories and more than 30 kinds.
At present, my country provides seven free AIDS treatment drugs, and some other effective "cocktail" drugs are also included in the scope of national medical insurance.
However, the limitations of traditional therapies are becoming more and more obvious.
On the one hand, traditional therapies cannot completely cure HIV and require lifelong medication.
ART only inhibits the replication of the virus at a low level, and cannot completely cure the disease; on the other hand, the treatment plan is complicated and poor compliance can easily lead to adverse consequences.
Taking drugs without following the doctor's advice or changing the drug collocation plan by yourself can easily lead to tolerance, reduce the intensity of treatment, and make the condition develop further, which is difficult to control.
Potential treatments for AIDS · Gene editing to treat AIDS.
In recent years, the AIDS cure case that has shocked the medical world is the "Berlin patient" Timothy Ray Brown.
He is the first patient believed to have successfully cured HIV.
And the "London patient" may have also achieved a cure for AIDS.
Both the Berlin patient and the London patient suffer from both HIV and hematological tumors.
After receiving hematopoietic stem cell transplantation from donors with mutations in the CCR5 gene, both showed a cure/long-term remission of HIV.
Based on these two medical records, the researchers proposed to use gene editing technology to modify hematopoietic stem cells to knock out the original CCR5 gene.
Currently in this direction, the research of Professor Deng Hongkui's team from Peking University is one of the fastest-moving studies.
In September 2019, Deng Hongkui’s team reported on a patient’s research data in an article published online in the “Brief Report” column of the famous NEJM.
The results showed that a mixed stem cell of edited and unedited cells was implanted in the recipient and reached a complete donor.
The cells were chimerased and continued until the data cutoff.
At 19 months, the leukemia was in remission, but the patient was still infected with HIV and received antiretroviral therapy.
Recommended reading: The Road to the Rise of CRISPR! Hongkui Deng was selected as one of the top ten scientific figures in nature, and the first CRISPR human test in the United States was listed as one of the top ten scientific stories.
Yimai Meng revealed that HIV patients have long-term benefits! CCR5 gene-edited T cell therapy to rebuild immune functionYimaihei Technology In addition, there are also studies exploring the use of CRISPR gene editing to treat HIV.
On July 2, 2019, researchers from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) published a study on Nature Communications for the first time in history.
The HIV-1 DNA (the virus responsible for AIDS) that has the ability to replicate is eliminated from the genome.
Recommended reading: Nature Sub-Journal: AIDS treatment ushered in a milestone! CRISPR combined with long-acting antiviral therapy to completely eliminate HIV virus DNA in animals for the first time Yimai Meng broke the news · AAV gene therapy to treat AIDS March 9, 2020, National Institutes of Health (NIH) Institute of Allergy and Infectious Diseases (NIAID) ) Researchers at the CROI 2020 conference orally reported a blockbuster long-term remission or functional cure study for AIDS, which caused great repercussions.
In the NIH phase 1 clinical trial VRC 603, an adeno-associated virus (AAV8) was used to deliver the antibody (VRC07) gene to human cells, guiding the human body to produce this specific antibody VRC07 against HIV.
The new method enables the human body to produce antibodies against HIV over a long period of time.
According to the researchers, with further development, this strategy can be applied to prevent and treat various infectious diseases.
Recommended reading: A major breakthrough in the field of AIDS.
The broad-spectrum neutralizing antibody delivered by AAV showed safe and long-lasting efficacy for the first time Yimai Meng broke the news.
CAR-T cell therapy for AIDS CAR-T cell, as a new type of immune cell therapy, has been It has achieved certain success in hematological tumors, and researchers are also applying CAR-T cell therapy to other diseases such as HIV.
In August 2020, Nature Medicine published a research article showing that a dual CAR-T cell can effectively help the human body resist HIV infection.
Studies have shown that dual CAR-T can target and quickly eliminate HIV-infected cells.
In April 2021, the UCLA research team published a research article in the journal PLOS Pathogens, showing that a CAR cell therapy has good effectiveness and durability for HIV treatment.
Researchers have developed a CAR that contains CD4 molecules to block the combination of HIV virus and CD4 molecules on normal T cells.
At the same time, the CAR is installed on genetically modified stem cells and then transplanted into patients.
Treat HIV.
Recommended reading: New strategies for treating HIV! CAR gene therapy shows good effectiveness and durability.
Yimaihei Technology · Immune Checkpoint Inhibitors to treat AIDS In recent years, immune checkpoint inhibitor (ICI) drugs have been used to a certain extent in cancer patients infected with HIV.
Tests, some results suggest that immune checkpoint inhibitors may play a role in the treatment of HIV infection.
This is mainly due to the fact that ICI has become widely known in recent years because it has changed the treatment of cancer.
Another phenomenon is that patients infected with HIV have an increased risk of cancer.
Among these patients, non-HIV-related malignancies such as lung cancer, anal cancer, Hodgkin’s lymphoma, oral or throat cancer have become one of the main causes of death for HIV-infected patients.
A review published in JAMAOncology in February 2019 conducted a systematic review of these literatures and evaluated the safety and effectiveness of ICI in the treatment of patients with HIV infection and advanced cancer, indicating that there is no clear prospective data to prove the safety risk Under the circumstances, ICI therapy may be a viable treatment option for AIDS+ advanced cancer patients.
Reference materials: 1.
https:// is always committed to Original news reports on cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, among which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institution users exceeded 5 %.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
The clinical trial aims to evaluate the safety of AGT103-T, a cellular gene therapy product.
In this trial, named RePAIR (NCT04561258), participants were injected with their own CD4 T cells at a time, which are rich in cells that can respond to HIV and undergo genetic modification to fight infection.
On May 19, the Washington Institute of Health in Washington, D.
C.
completed the first infusion.
AGT103-T is a genetically modified cell product made from the body's own cells, rich in CD4 T cells with HIV specificity and resistance.
The AGT method is unique in that it is dedicated to repairing the critical immune system damage caused by HIV.
HIV infects the human body to cause this specific damage, which means that the T helper cells needed for immunization against HIV are also killed, so the infected person will not be able to eliminate HIV through their own immune system and become chronically infected.
The AGT method aims to repair T helper cell defects and provide durable virus control.
Even if the sequence of the HIV strain changes, or the path to enter and infect T cells is changed, the virus control provided by the AGT treatment method will not be affected.
AGT's HIV treatment drug AGT103-T, as an HIV treatment drug launched by AGT, can remove infected cells in the body and reduce or eliminate the need for lifelong antiretroviral therapy.
As early as October 2019, AGT announced the submission of an IND application to the FDA for its HIV project.
In August 2020, the FDA approved AGT to advance the Phase 1 clinical trial of its HIV treatment program.
The first patient confirmed to participate in the trial on October 12, 2020, marking the actual start of the study.
In the same month, patients underwent leukopak (immune cell blood draw), based on which AGT carried out their proprietary process in gene therapy, and carried out more than 70 days of large-scale product quality control.
The Data and Safety Monitoring Board (DSMB) will evaluate the safety data of the first participating patient in July 2021 and determine whether the study can continue.
AGT expects to complete the main content in June 2022, and the entire study is expected to end in September 2022.
Chief Scientific Officer Dr.
C.
David Pauza said: “The first treatment of individuals with our product is an important step forward and the culmination of the design, development, manufacturing and approval of this product in human testing.
We It is believed that this therapy can change the human body’s ability to fight HIV, and the research of the first human trial also marks that we have a better understanding of what results this innovative therapy can achieve.
"This is the first time AGT103-T has been applied to the human body.
the study.
The primary end point of this study is to evaluate the safety of AGT103-T in HIV test patients receiving antiretroviral therapy and well-controlled viremia; tests related to the secondary end point are used to assess the participant’s response to the treatment.
Including changes in the immune response to HIV.
This safety study will follow up participants treated with AGT103-T for 6 months, and then participate in the 15-year long-term follow-up required for all gene therapy trials prescribed by the FDA.
The study is divided into a low-dose cohort and a high-dose cohort.
It is expected that the number of participants in the trial will be 6 and a parallel grouping trial will be conducted.
The number of transgenic T cells in a single infusion in the low-dose cohort was between 1x10e8 and 1x10e9, while the number of cells in a single infusion in the high-dose cohort was between 1x10e9 and 5x10e9.
In the treatment of AGT, the number of HIV-specific immune cells protected and returned to the participants will be nearly 2,000 times the number reached in the previous clinical trial of Sangamo Therapeutics Biopharmaceutical Co.
, Ltd.
In the previous trial, the patient's response rate was only 10%.
The AGT data has been replicated in NIH Research Institute NIAID, the world's top HIV laboratory, verifying that the therapy has significant efficacy and prospects for curing HIV.
CEO Jeff Galvin said: "This project represents an important step forward in the effectiveness of this method.
In the HIV therapeutic community, this method has significant theoretical and empirical momentum.
" He continued.
"Now that we have seen some evidence that patients are tolerant to the treatment, I believe that we will soon see signs of efficacy, which will convince the scientific community that the cure for HIV has been achieved or is very close.
I
I am extremely happy and proud of the team.
I am extremely optimistic about the future of this cell therapy and the ultimate contribution of AGT to HIV treatment.
"The traditional treatment of AIDS HIV (HIV) infection is a global one.
The epidemic has spread to more than 200 countries and regions, and the total number of infected people exceeds 60 million.
About one-third of new infections occur in people aged 15-24.
With the development of medicine, AIDS has gone from incurable to preventable and controllable.
In 1996, Chinese-American scientist He Dayi proposed the "cocktail" therapy, which immediately reduced the AIDS-related mortality rate at that time by 60%-80%.
It has now become the traditional mainstream AIDS treatment method. The so-called "cocktail" therapy refers to high-efficiency antiretroviral therapy (HAART), which uses three or more mixed drugs, such as antiviral protease drugs, antiviral reverse transcription drugs, etc.
, to target HIV infection in humans.
Combining drugs in different links can inhibit virus replication at a low level.
Nowadays, AIDS treatment drugs can be divided into six categories and more than 30 kinds.
At present, my country provides seven free AIDS treatment drugs, and some other effective "cocktail" drugs are also included in the scope of national medical insurance.
However, the limitations of traditional therapies are becoming more and more obvious.
On the one hand, traditional therapies cannot completely cure HIV and require lifelong medication.
ART only inhibits the replication of the virus at a low level, and cannot completely cure the disease; on the other hand, the treatment plan is complicated and poor compliance can easily lead to adverse consequences.
Taking drugs without following the doctor's advice or changing the drug collocation plan by yourself can easily lead to tolerance, reduce the intensity of treatment, and make the condition develop further, which is difficult to control.
Potential treatments for AIDS · Gene editing to treat AIDS.
In recent years, the AIDS cure case that has shocked the medical world is the "Berlin patient" Timothy Ray Brown.
He is the first patient believed to have successfully cured HIV.
And the "London patient" may have also achieved a cure for AIDS.
Both the Berlin patient and the London patient suffer from both HIV and hematological tumors.
After receiving hematopoietic stem cell transplantation from donors with mutations in the CCR5 gene, both showed a cure/long-term remission of HIV.
Based on these two medical records, the researchers proposed to use gene editing technology to modify hematopoietic stem cells to knock out the original CCR5 gene.
Currently in this direction, the research of Professor Deng Hongkui's team from Peking University is one of the fastest-moving studies.
In September 2019, Deng Hongkui’s team reported on a patient’s research data in an article published online in the “Brief Report” column of the famous NEJM.
The results showed that a mixed stem cell of edited and unedited cells was implanted in the recipient and reached a complete donor.
The cells were chimerased and continued until the data cutoff.
At 19 months, the leukemia was in remission, but the patient was still infected with HIV and received antiretroviral therapy.
Recommended reading: The Road to the Rise of CRISPR! Hongkui Deng was selected as one of the top ten scientific figures in nature, and the first CRISPR human test in the United States was listed as one of the top ten scientific stories.
Yimai Meng revealed that HIV patients have long-term benefits! CCR5 gene-edited T cell therapy to rebuild immune functionYimaihei Technology In addition, there are also studies exploring the use of CRISPR gene editing to treat HIV.
On July 2, 2019, researchers from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) published a study on Nature Communications for the first time in history.
The HIV-1 DNA (the virus responsible for AIDS) that has the ability to replicate is eliminated from the genome.
Recommended reading: Nature Sub-Journal: AIDS treatment ushered in a milestone! CRISPR combined with long-acting antiviral therapy to completely eliminate HIV virus DNA in animals for the first time Yimai Meng broke the news · AAV gene therapy to treat AIDS March 9, 2020, National Institutes of Health (NIH) Institute of Allergy and Infectious Diseases (NIAID) ) Researchers at the CROI 2020 conference orally reported a blockbuster long-term remission or functional cure study for AIDS, which caused great repercussions.
In the NIH phase 1 clinical trial VRC 603, an adeno-associated virus (AAV8) was used to deliver the antibody (VRC07) gene to human cells, guiding the human body to produce this specific antibody VRC07 against HIV.
The new method enables the human body to produce antibodies against HIV over a long period of time.
According to the researchers, with further development, this strategy can be applied to prevent and treat various infectious diseases.
Recommended reading: A major breakthrough in the field of AIDS.
The broad-spectrum neutralizing antibody delivered by AAV showed safe and long-lasting efficacy for the first time Yimai Meng broke the news.
CAR-T cell therapy for AIDS CAR-T cell, as a new type of immune cell therapy, has been It has achieved certain success in hematological tumors, and researchers are also applying CAR-T cell therapy to other diseases such as HIV.
In August 2020, Nature Medicine published a research article showing that a dual CAR-T cell can effectively help the human body resist HIV infection.
Studies have shown that dual CAR-T can target and quickly eliminate HIV-infected cells.
In April 2021, the UCLA research team published a research article in the journal PLOS Pathogens, showing that a CAR cell therapy has good effectiveness and durability for HIV treatment.
Researchers have developed a CAR that contains CD4 molecules to block the combination of HIV virus and CD4 molecules on normal T cells.
At the same time, the CAR is installed on genetically modified stem cells and then transplanted into patients.
Treat HIV.
Recommended reading: New strategies for treating HIV! CAR gene therapy shows good effectiveness and durability.
Yimaihei Technology · Immune Checkpoint Inhibitors to treat AIDS In recent years, immune checkpoint inhibitor (ICI) drugs have been used to a certain extent in cancer patients infected with HIV.
Tests, some results suggest that immune checkpoint inhibitors may play a role in the treatment of HIV infection.
This is mainly due to the fact that ICI has become widely known in recent years because it has changed the treatment of cancer.
Another phenomenon is that patients infected with HIV have an increased risk of cancer.
Among these patients, non-HIV-related malignancies such as lung cancer, anal cancer, Hodgkin’s lymphoma, oral or throat cancer have become one of the main causes of death for HIV-infected patients.
A review published in JAMAOncology in February 2019 conducted a systematic review of these literatures and evaluated the safety and effectiveness of ICI in the treatment of patients with HIV infection and advanced cancer, indicating that there is no clear prospective data to prove the safety risk Under the circumstances, ICI therapy may be a viable treatment option for AIDS+ advanced cancer patients.
Reference materials: 1.
https:// is always committed to Original news reports on cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, among which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institution users exceeded 5 %.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
