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Posted On: 01/18/2021 10:40:26 PM
Post# of 148902
Hot off the presses, "Antibodies to watch in 2021." Leronlimab is featured not once, but twice. Looks like the NIH is interested too.
Abstract: https://pubmed.ncbi.nlm.nih.gov/33459118/
Full publication: https://www.tandfonline.com/doi/full/10.1080/...20.1860476
Here are the highlights:
"Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 ( leronlimab , tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021."
Re: EUA requested
"As of November 20, 2020, an EUA request for leronlimab for the treatment of COVID-19 had been submitted to the FDA, and both bamlanivimab and REGN-COV2 were authorized for emergency use by the FDA. Bamlanivimab and REGN-COV2 target the SARS-CoV-2 virus and thus reduce the viral load, while leronlimab targets CCR5 and is intended to treat symptoms of COVID-19."
Re: COVID-19
"Leronlimab (Cytodyn Inc.)
Leronlimab is a humanized anti-CCR5 IgG4 antibody developed for a variety of indications, including HIV, stroke, graft-vs.-host disease (GvHD), triple-negative breast cancer (TNBC), as well as COVID-19. Among other roles, CCR5 modulates immune cell trafficking to sites of inflammation. Data from COVID-19 patients (n = 23) receiving 700 mg leronlimab on an open-label compassionate use basis have suggested that the drug may improve outcomes. 22
CytoDyn completed a Phase 2 clinical trial (NCT04343651, CD10) that compared the efficacy and safety of leronlimab vs. placebo for mild to moderate COVID-19. Patients are being recruiting for a Phase 2b/3 trial (CD12, NCT04347239) to evaluate the efficacy and safety of leronlimab for patients with severe or critical COVID-19. In this adaptive-design multicenter study, patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo, which are each administered via subcutaneous (SC) injection.
Cytodyn disclosed in an investment community conference call that they requested an EUA from FDA for leronlimab for mild to moderate COVID-19 based on data from the Phase 2 CD10 study. Top-level results of the study showed that, in patients with Total Clinical Symptom Scores of ≥4 at baseline (higher scores equate to poorer health state), at Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo)."
Re: HIV:
"Leronlimab (CytoDyn Inc.)
Leronlimab’s target, CCR5, has been implicated in many pathophysiological processes, such as human immunodeficiency virus (HIV)-1 entry into CD4 + T cells, promotion of tumor invasion and metastases, pathogenesis of nonalcoholic steatohepatitis, development of aGvHD, as well as inflammation. FDA has granted leronlimab a Fast Track designation as a combination therapy with highly active antiretroviral therapy for HIV-infected patients. CytoDyn Inc. submitted the non-clinical portion of a BLA for leronlimab (700 mg dose) as combination therapy with an antiretroviral regimen for HIV patients who are highly treatment-experienced, but the company announced in July 2020 that FDA refused to file the BLA due to the absence of information needed to complete a substantive review. CytoDyn intends to re-submit the BLA."
Abstract: https://pubmed.ncbi.nlm.nih.gov/33459118/
Full publication: https://www.tandfonline.com/doi/full/10.1080/...20.1860476
Here are the highlights:
"Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 ( leronlimab , tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021."
Re: EUA requested
"As of November 20, 2020, an EUA request for leronlimab for the treatment of COVID-19 had been submitted to the FDA, and both bamlanivimab and REGN-COV2 were authorized for emergency use by the FDA. Bamlanivimab and REGN-COV2 target the SARS-CoV-2 virus and thus reduce the viral load, while leronlimab targets CCR5 and is intended to treat symptoms of COVID-19."
Re: COVID-19
"Leronlimab (Cytodyn Inc.)
Leronlimab is a humanized anti-CCR5 IgG4 antibody developed for a variety of indications, including HIV, stroke, graft-vs.-host disease (GvHD), triple-negative breast cancer (TNBC), as well as COVID-19. Among other roles, CCR5 modulates immune cell trafficking to sites of inflammation. Data from COVID-19 patients (n = 23) receiving 700 mg leronlimab on an open-label compassionate use basis have suggested that the drug may improve outcomes. 22
CytoDyn completed a Phase 2 clinical trial (NCT04343651, CD10) that compared the efficacy and safety of leronlimab vs. placebo for mild to moderate COVID-19. Patients are being recruiting for a Phase 2b/3 trial (CD12, NCT04347239) to evaluate the efficacy and safety of leronlimab for patients with severe or critical COVID-19. In this adaptive-design multicenter study, patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo, which are each administered via subcutaneous (SC) injection.
Cytodyn disclosed in an investment community conference call that they requested an EUA from FDA for leronlimab for mild to moderate COVID-19 based on data from the Phase 2 CD10 study. Top-level results of the study showed that, in patients with Total Clinical Symptom Scores of ≥4 at baseline (higher scores equate to poorer health state), at Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo)."
Re: HIV:
"Leronlimab (CytoDyn Inc.)
Leronlimab’s target, CCR5, has been implicated in many pathophysiological processes, such as human immunodeficiency virus (HIV)-1 entry into CD4 + T cells, promotion of tumor invasion and metastases, pathogenesis of nonalcoholic steatohepatitis, development of aGvHD, as well as inflammation. FDA has granted leronlimab a Fast Track designation as a combination therapy with highly active antiretroviral therapy for HIV-infected patients. CytoDyn Inc. submitted the non-clinical portion of a BLA for leronlimab (700 mg dose) as combination therapy with an antiretroviral regimen for HIV patients who are highly treatment-experienced, but the company announced in July 2020 that FDA refused to file the BLA due to the absence of information needed to complete a substantive review. CytoDyn intends to re-submit the BLA."
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