Race is on-Medical China report on Cytodyn:
1st. https://med.sina.com/article_detail_100_2_65739.html
2nd. Las Vegas News report for China:
https://lvcnn.com/cn/news.php?id=29933
Translation:
Banlangen in monoclonal antibody? Following HIV and breast cancer, leronlimab challenged NASH!
Source: Sina Pharmaceutical News 2019-05-14A-A +
CytoDyn is a biotechnology company focused on the development of a new humanized CCR5 monoclonal antibody leronlimab (PRO140) for a variety of therapeutic indications. Recently, the company announced a cooperation agreement with Dr. Daniel Lindne of the Cleveland Clinic to test the ability of leronlimab to prevent non-alcoholic steatohepatitis (NASH) in a humanized mouse model. Previously, Pfizer's HIV drug maraviroc has been shown to improve liver steatosis progression in a mouse model of non-alcoholic fatty liver disease (NAFLD). Therefore, CytoDyn also plans to explore the potential of leronlimab in this area.
NAFLD is an inflammatory disease caused by liver cell fat accumulation (fatty degeneration). In severe cases, NAFLD will develop into NASH. According to data provided by the NASH Education Program website, between 2015 and 2030, 25.2% of adults worldwide may have NAFLD and the prevalence of NASH will increase by 63%. In the United States, it is estimated that 30% -40% of adults have NAFLD, and 3% -12% of adults have NASH.
Without treatment, NASH may develop into hepatocellular carcinoma, and NASH is expected to become the main cause of liver transplantation by 2020. According to estimates by the World Journal of Gastroenterology, the continuing increase in the incidence of obesity and diabetes worldwide is the main reason for the rise in the prevalence of NASH. The US FDA pointed out that the development of therapies that can slow the progression of the disease, stop or reverse NASH and NAFLD will solve the significant unmet medical needs in this field.
Despite the increasing awareness of NASH, the disease is still difficult to diagnose and there is currently no approved treatment. In many clinical studies and unrelated third-party studies, the CCR5 signaling pathway has been shown to be a potential key target of NASH. In more than 700 patients, leronlimab did not show liver toxicity associated with other CCR5 antagonists. In addition, leronlimab can provide a lower frequency of administration, with the unique ability to be used as a monotherapy or in synergy with other molecular compounds. Several NASH studies on other CCR5 drugs have shown anti-inflammatory and anti-fibrotic effects.
Dr. Nader Pourhassan, president and chief executive officer of Cytodyn, said that if leronlimab successfully completed the NASH proof-of-concept study, it will immediately submit an investigational new drug application and plan for the Phase II study to the FDA.
Leronlimab blocks HIV from entering cells and blocks CCR5 / CCL5 to treat cancer (Image source: CytoDyn official website)
CCR5 is called chemokine receptor 5, which was highly concerned by the "gene editing baby" event at the end of November last year. This is a cellular receptor that plays multiple roles in HIV infection, tumor metastasis, and immune signal transduction.
Leronlimab is a humanized IgG4 monoclonal antibody targeting CCR5. This antibody is called the "isatis root" of the monoclonal antibody field, and has demonstrated positive effects in the treatment of various diseases, including HIV and triple negative breast cancer (TNBC). Previously, the FDA has granted leronlimab combined with high-efficiency antiretroviral therapy to treat HIV infection, combined with carboplatin to treat CCR5-positive metastatic TNBC fast-track qualification, and the treatment of acute graft versus host disease (aGVHD) orphan drug qualification.
HIV / AIDS
Leronlimab belongs to a new treatment called a viral entry inhibitor that can mask CCR5 and protect these cells from viral infection by blocking the entry of major HIV (R5) subtypes into healthy T cells. Up to now, in the treatment of HIV, leronlimab has successfully completed nine phase I / II / III clinical trials with more than 700 subjects. Each study shows that leronlimab can significantly reduce or control HIV viral load. This includes a key phase III clinical study using leronlimab in combination with standard antiretroviral therapy for HIV-infected patients who have previously received treatment.
CytoDyn plans to submit leronlimab's biologics license application for HIV treatment to the FDA in the first half of this year. The company is also conducting another phase III study, using leronlimab as a weekly monotherapy for HIV-infected patients.
Cancer
Studies have shown that CCR5 may play a central role in tumor invasion and metastasis, and increased CCR5 expression is an indicator of several cancer states. Studies have also shown that in laboratory and animal models, blocking CCR5 drugs can block tumor metastasis of aggressive breast and prostate cancer.
CytoDyn is conducting a number of studies to explore the potential of leronlimab to treat cancer. At the end of November last year, it was approved by the FDA to start the Phase Ib / II clinical study of leronlimab in the treatment of metastatic TNBC. The company plans to initiate additional Phase II clinical trials at the appropriate time. In February of this year, CytoDyn launched 8 preclinical studies to evaluate leronlimab in the treatment of 8 types of cancer, including: melanoma, pancreatic cancer, breast cancer, prostate cancer, colon cancer, lung cancer, liver cancer, and stomach cancer.
In early May, data from a mouse model of human breast cancer metastasis treated with leronlimab showed that compared with untreated mice, the burden of breast cancer metastasis in mice treated for 8 weeks decreased by 98%. The data will be used to support orphan drug qualification applications for leronlimab in the treatment of metastatic TNBC.
Immunological signal transduction
The CCR5 receptor also seems to play a central role in modulating the transfer of immune cells to the site of inflammation, and may be crucial for the development of aGVHD and other inflammatory diseases. Clinical studies in other institutions further support the use of chemical inhibitors to block CCR5 to reduce the clinical impact of aGvHD without significantly affecting the implantation of transplanted bone marrow stem cells.
CytoDyn is conducting a phase II clinical study on leronlimab, which further supports the view that the CCR5 receptor implanted on cells is essential for the development of aGvHD, and blocking this receptor from recognizing certain immune signaling molecules is feasible to relieve aGvHD method. Previously, the FDA has granted leronlimab orphan drug qualification to prevent GvHD.
On May 2nd, CytoDyn released an investor statement detailing the important milestones of leronlimab clinical development projects, future prospects, and the treatment of HIV and cancer in 2019. (Sina Medical Compilation / newborn)
Reference source: CytoDyn Initiates Pre-Clinical Study of Leronlimab (PRO 140) to Prevent NASH with The Cleveland Clinic's Dr. Daniel J. Lindner, MD, Ph.D.
* Disclaimer: This article was written by an author who has settled in Sina Pharmaceutical News. The opinions represent the author himself and do not represent Sina Pharmaceutical News ’position.
1st. https://med.sina.com/article_detail_100_2_65739.html
2nd. Las Vegas News report for China:
https://lvcnn.com/cn/news.php?id=29933
Translation:
Banlangen in monoclonal antibody? Following HIV and breast cancer, leronlimab challenged NASH!
Source: Sina Pharmaceutical News 2019-05-14A-A +
CytoDyn is a biotechnology company focused on the development of a new humanized CCR5 monoclonal antibody leronlimab (PRO140) for a variety of therapeutic indications. Recently, the company announced a cooperation agreement with Dr. Daniel Lindne of the Cleveland Clinic to test the ability of leronlimab to prevent non-alcoholic steatohepatitis (NASH) in a humanized mouse model. Previously, Pfizer's HIV drug maraviroc has been shown to improve liver steatosis progression in a mouse model of non-alcoholic fatty liver disease (NAFLD). Therefore, CytoDyn also plans to explore the potential of leronlimab in this area.
NAFLD is an inflammatory disease caused by liver cell fat accumulation (fatty degeneration). In severe cases, NAFLD will develop into NASH. According to data provided by the NASH Education Program website, between 2015 and 2030, 25.2% of adults worldwide may have NAFLD and the prevalence of NASH will increase by 63%. In the United States, it is estimated that 30% -40% of adults have NAFLD, and 3% -12% of adults have NASH.
Without treatment, NASH may develop into hepatocellular carcinoma, and NASH is expected to become the main cause of liver transplantation by 2020. According to estimates by the World Journal of Gastroenterology, the continuing increase in the incidence of obesity and diabetes worldwide is the main reason for the rise in the prevalence of NASH. The US FDA pointed out that the development of therapies that can slow the progression of the disease, stop or reverse NASH and NAFLD will solve the significant unmet medical needs in this field.
Despite the increasing awareness of NASH, the disease is still difficult to diagnose and there is currently no approved treatment. In many clinical studies and unrelated third-party studies, the CCR5 signaling pathway has been shown to be a potential key target of NASH. In more than 700 patients, leronlimab did not show liver toxicity associated with other CCR5 antagonists. In addition, leronlimab can provide a lower frequency of administration, with the unique ability to be used as a monotherapy or in synergy with other molecular compounds. Several NASH studies on other CCR5 drugs have shown anti-inflammatory and anti-fibrotic effects.
Dr. Nader Pourhassan, president and chief executive officer of Cytodyn, said that if leronlimab successfully completed the NASH proof-of-concept study, it will immediately submit an investigational new drug application and plan for the Phase II study to the FDA.
Leronlimab blocks HIV from entering cells and blocks CCR5 / CCL5 to treat cancer (Image source: CytoDyn official website)
CCR5 is called chemokine receptor 5, which was highly concerned by the "gene editing baby" event at the end of November last year. This is a cellular receptor that plays multiple roles in HIV infection, tumor metastasis, and immune signal transduction.
Leronlimab is a humanized IgG4 monoclonal antibody targeting CCR5. This antibody is called the "isatis root" of the monoclonal antibody field, and has demonstrated positive effects in the treatment of various diseases, including HIV and triple negative breast cancer (TNBC). Previously, the FDA has granted leronlimab combined with high-efficiency antiretroviral therapy to treat HIV infection, combined with carboplatin to treat CCR5-positive metastatic TNBC fast-track qualification, and the treatment of acute graft versus host disease (aGVHD) orphan drug qualification.
HIV / AIDS
Leronlimab belongs to a new treatment called a viral entry inhibitor that can mask CCR5 and protect these cells from viral infection by blocking the entry of major HIV (R5) subtypes into healthy T cells. Up to now, in the treatment of HIV, leronlimab has successfully completed nine phase I / II / III clinical trials with more than 700 subjects. Each study shows that leronlimab can significantly reduce or control HIV viral load. This includes a key phase III clinical study using leronlimab in combination with standard antiretroviral therapy for HIV-infected patients who have previously received treatment.
CytoDyn plans to submit leronlimab's biologics license application for HIV treatment to the FDA in the first half of this year. The company is also conducting another phase III study, using leronlimab as a weekly monotherapy for HIV-infected patients.
Cancer
Studies have shown that CCR5 may play a central role in tumor invasion and metastasis, and increased CCR5 expression is an indicator of several cancer states. Studies have also shown that in laboratory and animal models, blocking CCR5 drugs can block tumor metastasis of aggressive breast and prostate cancer.
CytoDyn is conducting a number of studies to explore the potential of leronlimab to treat cancer. At the end of November last year, it was approved by the FDA to start the Phase Ib / II clinical study of leronlimab in the treatment of metastatic TNBC. The company plans to initiate additional Phase II clinical trials at the appropriate time. In February of this year, CytoDyn launched 8 preclinical studies to evaluate leronlimab in the treatment of 8 types of cancer, including: melanoma, pancreatic cancer, breast cancer, prostate cancer, colon cancer, lung cancer, liver cancer, and stomach cancer.
In early May, data from a mouse model of human breast cancer metastasis treated with leronlimab showed that compared with untreated mice, the burden of breast cancer metastasis in mice treated for 8 weeks decreased by 98%. The data will be used to support orphan drug qualification applications for leronlimab in the treatment of metastatic TNBC.
Immunological signal transduction
The CCR5 receptor also seems to play a central role in modulating the transfer of immune cells to the site of inflammation, and may be crucial for the development of aGVHD and other inflammatory diseases. Clinical studies in other institutions further support the use of chemical inhibitors to block CCR5 to reduce the clinical impact of aGvHD without significantly affecting the implantation of transplanted bone marrow stem cells.
CytoDyn is conducting a phase II clinical study on leronlimab, which further supports the view that the CCR5 receptor implanted on cells is essential for the development of aGvHD, and blocking this receptor from recognizing certain immune signaling molecules is feasible to relieve aGvHD method. Previously, the FDA has granted leronlimab orphan drug qualification to prevent GvHD.
On May 2nd, CytoDyn released an investor statement detailing the important milestones of leronlimab clinical development projects, future prospects, and the treatment of HIV and cancer in 2019. (Sina Medical Compilation / newborn)
Reference source: CytoDyn Initiates Pre-Clinical Study of Leronlimab (PRO 140) to Prevent NASH with The Cleveland Clinic's Dr. Daniel J. Lindner, MD, Ph.D.
* Disclaimer: This article was written by an author who has settled in Sina Pharmaceutical News. The opinions represent the author himself and do not represent Sina Pharmaceutical News ’position.
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