A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are:
1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with MSS, mCRC who have progressed on prior treatment before participating in the study.
2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

开始日期2025-06-16

申办/合作机构

CytoDyn, Inc.

[+1]

NCT05730673

/ Withdrawn临床2期

A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

开始日期2022-09-20

申办/合作机构

CytoDyn, Inc.

[+1]

NCT04901689

/ Suspended临床3期IIT

A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation

Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19).
The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation (ECMO).

开始日期2021-10-23

申办/合作机构

Hospital Israelita Albert Einstein

[+1]

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项与 CytoDyn, Inc. 相关的文献（医药）

2025-06-01·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): A Randomized, Double-Blind, Placebo-Controlled Trial

Article

作者: Hansen, Scott G. ; Dejesus, Edwin ; Sanchez, William E. ; Gathe, Joseph C. ; Meidling, Joseph ; Lalezari, Jacob P. ; Sacha, Jonah B. ; Krishen, Alok ; Ramgopal, Moti N. ; Rolle, Charlotte-Paige ; Yang, Otto O.

Background::

Leronlimab is a humanized κ-IgG4 monoclonal antibody that blocks C–C chemokine receptor type 5. We investigated leronlimab as a treatment option for people living with multidrug-resistant HIV-1.

Setting and Methods::

In a phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study conducted in 21 hospital centers in the United States, treatment-experienced people living with HIV with documented drug resistance were randomly assigned once weekly leronlimab (350 mg subcutaneously) or matching placebo for 1 week overlapping existing failing antiretroviral therapy, followed by a 24-week single-arm extension with weekly leronlimab combined with a new optimized background treatment. The primary end point was achieving ≥0.5 log10 reduction in plasma HIV-1 RNA from baseline at the end of the 1-week double-blinded treatment period.

Results::

Fifty-two participants were enrolled (25 leronlimab and 27 placebo). After the 1-week randomized phase, by the intent-to-treat analysis, 64.0% (16/25) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 23.1% (6/26) receiving placebo (P = 0.0032), whereas by per protocol analysis, 72.7% (16/22) receiving leronlimab achieved ≥0.5 log10 reduction in plasma HIV-1 RNA versus 24.0% (6/25) receiving placebo (P = 0.0008). Leronlimab was generally well tolerated with no drug-related serious adverse events reported. Overall, 175 adverse events were reported by 34/52 participants, with 120 (68.6%) adverse events categorized as mild.

Conclusions::

Leronlimab resulted in significantly reduced plasma HIV-1 within 1 week after addition to failing antiretroviral therapy. After 24 weeks combined with an optimized background treatment, most participants had plasma HIV-1 RNA levels <50 copies per milliliter plasma, suggesting utility of leronlimab as a component of salvage therapy.

2024-11-01·CLINICAL THERAPEUTICS

A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19

Article

作者: Hansen, Scott G. ; Yang, Otto O ; Sammartino, Daniel ; Ogbuagu, Onyema ; Hansen, Scott G ; Lalezari, Jacob P ; Mansour, Ali ; Loftus, Richard ; Seethamraju, Harish ; Sacha, Jonah B ; Arman, Arvin Cyrus ; Sacha, Jonah B. ; Ojha, Sohita ; Lalezari, Jacob P. ; Yang, Otto O.

PURPOSE:

Early in the course of the SARS-CoV-2 pandemic it was hypothesised that host genetics played a role in the pathophysiology of COVID-19 including a suggestion that the CCR5-Δ32 mutation may be protective in SARS-CoV-2 infection. Leronlimab is an investigational CCR5-specific humanized IgG4 monoclonal antibody currently in development for HIV-1 infection. We aimed to explore the impact of leronlimab on the severity of disease symptoms among participants with mild-to-moderate COVID-19.

METHODS:

The TEMPEST trial was a randomized, double-blind, placebo-controlled study in participants with mild-to-moderate COVID-19. Participants were randomly assigned in a 2:1 ratio to receive subcutaneous leronlimab (700 mg) or placebo on days 0 and 7. The primary efficacy endpoint was assessed by change in total symptom score based on fever, myalgia, dyspnea, and cough, at end of treatment (day 14).

FINDINGS:

Overall, 84 participants were randomized and treated with leronlimab (n = 56) or placebo (n = 28). No difference was observed in change in total symptom score (P = 0.8184) or other pre-specified secondary endpoints between treatments. However, in a post hoc analysis, 50.0% of participants treated with leronlimab demonstrated improvements from baseline in National Early Warning Score 2 (NEWS2) at day 14, compared with 20·8% of participants in the placebo group (post hoc; p = 0.0223). Among participants in this trial with mild-to-moderate COVID-19 adverse events rates were numerically but not statistically significantly lower in leronlimab participants (33.9%) compared with placebo participants (50.0%).

IMPLICATIONS:

At the time the TEMPEST trial was designed although CCR5 was known to be implicated in COVID-19 disease severity the exact pathophysiology of SARS-CoV-2 infection was poorly understood. Today it is well accepted that SARS-CoV-2 infection in asymptomatic-to-mild cases is primarily characterized by viral replication, with a heightened immune response, accompanied by diminished viral replication in moderate-to-severe disease and a peak in inflammatory responses with excessive production of pro-inflammatory cytokines in critical disease. It is therefore perhaps not surprising that no differences between treatments were observed in the primary endpoint or in pre-specified secondary endpoints among participants with mild-to-moderate COVID-19. However, the results of the exploratory post hoc analysis showing that participants in the leronlimab group had greater improvement in NEWS2 assessment compared to placebo provided a suggestion that leronlimab may be associated with a lower likelihood of people with mild-to-moderate COVID-19 progressing to more severe disease and needs to be confirmed in other appropriately designed clinical trials.

CLINICALTRIALS:

gov/ct2/show/NCT04343651.

2021-02-01·International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases3区 · 医学

CCR5 inhibition in critical COVID-19 patients decreases inflammatory cytokines, increases CD8 T-cells, and decreases SARS-CoV2 RNA in plasma by day 14

3区 · 医学

ArticleOA

作者: Herrera, Monica ; Akalin, Enver ; Francisco, Edgar B ; Rodrigues, Hallison ; Gupta, Raavi ; Sacha, Jonah B ; Kelly, Scott ; Seethamraju, Harish ; Mahyari, Eisa ; Kazempour, Kazem ; Lalezari, Jay ; Plassmeyer, Matthew ; Wu, Helen L ; O'Halloran, Jane A ; Hall, Eric ; Park, Byung S ; Webb, Gabriela M ; Pise, Amruta ; Lelic, Alina ; Corley, Michael J ; Pourhassan, Nader ; Alpan, Oral ; Kdouh, Lama ; Bimber, Benjamin N ; Sugai, Christopher ; Pang, Alina P S ; Ndhlovu, Lishomwa C ; Patterson, Bruce K ; Mudd, Philip A ; Dhody, Kush

OBJECTIVE:

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now a global pandemic. Emerging results indicate a dysregulated immune response. Given the role of CCR5 in immune cell migration and inflammation, we investigated the impact of CCR5 blockade via the CCR5-specific antibody leronlimab on clinical, immunological, and virological parameters in severe COVID-19 patients.

METHODS:

In March 2020, 10 terminally ill, critical COVID-19 patients received two doses of leronlimab via individual emergency use indication. We analyzed changes in clinical presentation, immune cell populations, inflammation, as well as SARS-CoV-2 plasma viremia before and 14 days after treatment.

RESULTS:

Over the 14-day study period, six patients survived, two were extubated, and one discharged. We observed complete CCR5 receptor occupancy in all donors by day 7. Compared with the baseline, we observed a concomitant statistically significant reduction in plasma IL-6, restoration of the CD4/CD8 ratio, and resolution of SARS-CoV2 plasma viremia (pVL). Furthermore, the increase in the CD8 percentage was inversely correlated with the reduction in pVL (r = -0.77, p = 0.0013).

CONCLUSIONS:

Our study design precludes clinical efficacy inferences but the results implicate CCR5 as a therapeutic target for COVID-19 and they form the basis for ongoing randomized clinical trials.

186

项与 CytoDyn, Inc. 相关的新闻（医药）

2026-05-07

·PRNewswire

Physicians Committee Highlights Citizen Complaint Raising Questions About Research Integrity at OHSU

Complaint Calls for Review of Drug Company Ties to Monkey Research at OHSU PORTLAND, Ore., May 7, 2026 /PRNewswire/ -- The Physicians Committee for Responsible Medicine is calling attention to a citizen complaint filed with the Oregon Health & Science University (OHSU) Integrity Office that alleges concerning research practices involving OHSU, its primate experimentation center, and its relationship with a pharmaceutical company attempting to market an unproven drug. The complaint calls for an investigation into OHSU's association with CytoDyn and the investigational drug leronlimab, citing issues with research standards, financial relationships, and disclosure practices. The Physicians Committee for Responsible Medicine, a medical ethics nonprofit organization, is highlighting the complaint in light of its longstanding advocacy work to end primate experiments at OHSU. The organization has previously called for the Oregon National Primate Research Center (ONPRC) to stop experimenting on primates and shift instead to research methods that more reliably translate to human health outcomes and has supported a recent OHSU Board resolution to explore transitioning the ONPRC to a sanctuary model. "The primate center has been criticized for killing baby monkeys, dosing pregnant monkeys with alcohol and drugs, and failing to use better scientific methods," said Janine McCarthy, MPH, director of research policy at the Physicians Committee for Responsible Medicine. "This complaint raises a whole new set of concerns, related to questionable financial relationships." "The fact that the former CytoDyn CEO who was sentenced to prison for fraud is a co-author on a half-dozen research OHSU publications raises obvious questions," said Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine. "Enough is enough." The complaint, filed by an Oregon resident on April 30, requests an investigation into OHSU's primate experiments using CytoDyn's investigational drug. Publicly available federal records indicate CytoDyn and its former leadership have faced legal actions related to misleading statements made to investors about the progress of developing a treatment for HIV. The Physicians Committee supports this request for a review of OHSU's past and ongoing relationship with CytoDyn, in the interest of transparency and research integrity. To speak with Dr. Barnard or Ms. McCarthy, please contact Reina Pohl at 202-527-7326 or [email protected]. Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research. SOURCE Physicians Committee for Responsible Medicine 21% more press release views with Request a Demo

专利侵权

2026-05-05

·PRNewswire

Creatv Announces Five Clinical Data Presentations at ASCO 2026

MONMOUTH JUNCTION, N.J., May 5, 2026 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a cancer diagnostic blood testing company, is pleased to announce one poster presentation and four poster abstracts in conjunction with it's pharmaceutical company collaborators at the upcoming 2026 ASCO Annual Meeting, May 29-June 2, 2026, McCormick Place, Chicago, Illinois. Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC phase 3 trial for advanced metastatic breast cancer: An ongoing analysis. Abstract: 2652 Session Title: Developmental Therapeutics—Immunotherapy Poster Board: 442 Date and Time: May 30, 2026, 1:30 PM – 4:30 PM CDT Poster Abstracts in Collaboration with BriaCell, a clinical-stage immuno-oncology drug company, Abstract Title: Monitoring PD-L1 expression in circulating cancer associated cells for prediction of clinical outcomes in metastatic breast cancer patients treated with immune checkpoint inhibitors. Abstract: e14535 Abstract Title: Liquid biopsy to stratify metastatic breast cancer progression risk using multi-analyte cell subtyping prior to systemic therapy. Abstract: e15525 Poster Abstracts in Collaboration with CytoDyn, a biotechnology company developing innovative treatments for cancer. Abstract Title: Safety and 5-year survival following treatment with leronlimab plus physician's choice combination therapy in patients with metastatic triple-negative breast cancer. Abstract: e14535 Abstract Title: Leronlimab in combination with trifluridine/tipiracil (TAS-102) plus bevacizumab for patients with refractory metastatic colorectal cancer (mCRC): The phase 2 CLOVER study. Abstract: e13109 Creatv Bio's LifeTracDx® blood test, described in the abstracts above, was used in the various studies to rapidly develop companion/complementary diagnostic tools for specific cancer therapies and provided continuous monitoring of cancer patients for pharmaceutical companies to optimize therapy regimes. About Creatv Bio Creatv Bio is a CLIA-certified cancer diagnostics company providing laboratory testing services to pharmaceutical and research partners, as well as to patients for research and investigational purposes. The LifeTracDx® blood test is an analytically validated assay under ongoing research and development. Current research applications include evaluation of circulating biomarkers in oncology to support translational and exploratory studies. The assay is intended for research and investigational use only and is not intended for use in clinical diagnosis, prognosis, treatment selection, or disease monitoring. For our research studies and complete listing of peer-reviewed publications and scientific posters, please visit our website at creatvbio.com. Creatv contacts: SOURCE Creatv MicroTech, Inc. 21% more press release views with Request a Demo

免疫疗法临床3期临床2期临床结果

2026-05-02

·万物皆是药

医药资讯周报

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