A Phase Two Study Evaluating Two Doses of Leronlimab (Pro 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With CCR5+, 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 CCR5+, 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 CCR5+, 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.

Start Date30 May 2025

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

NCT05730673

/ WithdrawnPhase 2

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)

Start Date20 Sep 2022

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

NCT04901689

/ SuspendedPhase 3IIT

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).

Start Date23 Oct 2021

Sponsor / Collaborator

Hospital Israelita Albert Einstein

[+1]

100 Clinical Results associated with Leronlimab

100 Translational Medicine associated with Leronlimab

100 Patents (Medical) associated with Leronlimab

Literatures (Medical) associated with Leronlimab

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

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

Article

Author: Dejesus, Edwin ; Sanchez, William E. ; Hansen, Scott G. ; 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.

15 Apr 2025·JOURNAL OF VIROLOGY

Addition of a short HIV-1 fusion-inhibitory peptide to PRO 140 antibody dramatically increases its antiviral breadth and potency

Article

Author: Gao, Yue ; Zhu, Yuanmei ; Chen, Yue ; Su, Bin ; Gong, Yani ; Chong, Huihui ; Yan, Hongxia ; Li, Li ; He, Yuxian

ABSTRACT:

PRO 140, a humanized anti-HIV monoclonal antibody targeting the cell coreceptor CCR5, is currently under clinical trials, but it only affects CCR5-tropic viruses. In this study, we have engineered two tandem fusion proteins (2P23-PRO140SC and 2P23-PRO140-Fc) with bifunctional activity by adding short fusion-inhibitory peptide 2P23 to the single-chain fragment variable (scFv) of PRO 140 (PRO140SC) with or without the Fc domain of human IgG4. We first demonstrated that 2P23-PRO140SC and 2P23-PRO140-Fc could efficiently bind to the cell membranes through CCR5 anchoring, which did not affect the expression level of CCR5 on the cell surface. We then verified that the addition of 2P23 peptide to PRO140SC enabled a very potent activity against CXCR4-tropic HIV-1 isolates. As expected, the bispecific fusion proteins exhibited highly potent activities in inhibiting divergent HIV-1 subtypes and viral mutants that were resistant to the fusion inhibitors 2P23 and T20, and they displayed relatively low in vitro cytotoxicity. Furthermore, both the fusion proteins had robust in vivo anti-HIV activities in rats, with 2P23-PRO140-Fc much better than 2P23-PRO140SC. In conclusion, our studies have provided bispecific HIV-1 inhibitors that overcome the drawbacks of PRO 140 antibody and offered novel tools for studying the mechanisms of HIV-1 infection.

IMPORTANCE:

Given that HIV-1 evolves with high variability and drug resistance, the development of novel antivirals is important. CCR5-directed antibody PRO 140 is currently under clinical trials, but it only inhibits CCR5-tropic HIV-1 isolates. The designed fusion proteins by adding a minimum fusion-inhibitory peptide to PRO 140 enable dramatically increased activities in inhibiting both CCR5-tropic and CXCR4-tropic viruses, thus offering novel antiviral agents with a bispecific functionality that can overcome the drawbacks of PRO 140 antibody.

31 Dec 2024·mAbs

FcRn-enhancing mutations lead to increased and prolonged levels of the HIV CCR5-blocking monoclonal antibody leronlimab in the fetuses and newborns of pregnant rhesus macaques

Article

Author: Shaqra, Ala M ; Zikos, Joanna ; Usachenko, Jodie L ; Reed, Jason S ; Schiffer, Celia A ; Wu, Helen L ; Van Rompay, Koen K A ; Magnani, Diogo M ; Webb, Gabriela M ; Watanabe, Jennifer ; Sacha, Jonah B

Prenatal administration of monoclonal antibodies (mAbs) is a strategy that could be exploited to prevent viral infections during pregnancy and early life. To reach protective levels in fetuses, mAbs must be transported across the placenta, a selective barrier that actively and specifically promotes the transfer of antibodies (Abs) into the fetus through the neonatal Fc receptor (FcRn). Because FcRn also regulates Ab half-life, Fc mutations like the M428L/N434S, commonly known as LS mutations, and others have been developed to enhance binding affinity to FcRn and improve drug pharmacokinetics. We hypothesized that these FcRn-enhancing mutations could similarly affect the delivery of therapeutic Abs to the fetus. To test this hypothesis, we measured the transplacental transfer of leronlimab, an anti-CCR5 mAb, in clinical development for preventing HIV infections, using pregnant rhesus macaques to model in utero mAb transfer. We also generated a stabilized and FcRn-enhanced form of leronlimab, termed leronlimab-PLS. Leronlimab-PLS maintained higher levels within the maternal compartment while also reaching higher mAb levels in the fetus and newborn circulation. Further, a single dose of leronlimab-PLS led to complete CCR5 receptor occupancy in mothers and newborns for almost a month after birth. These findings support the optimization of FcRn interactions in mAb therapies designed for administration during pregnancy.

149

News (Medical) associated with Leronlimab

02 Jul 2025

·www.globenewswire.com

CytoDyn Announces Encouraging Survival Data in Patients with Metastatic Colorectal Cancer Previously Treated with Leronlimab

Positive results in patients with advanced mCRC emphasize potential significance of CytoDyn’s ongoing Phase II CRC trial Dr. Benjamin Weinberg to present final results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona, Spain July 01, 2025 -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced encouraging clinical findings among patients with advanced metastatic colorectal cancer (“mCRC”) previously treated with leronlimab. The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later. Dr. Benjamin Weinberg, Associate Professor at Georgetown University and Principal Investigator of CytoDyn’s colorectal cancer (“CRC”) program, will present the Company’s clinical data at the ESMO Gastrointestinal Cancers Congress 2025 taking place in Barcelona, Spain from July 2 to July 5, 2025. The results, from patients treated under a compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. They also support the rationale for the design and therapeutic potential of CytoDyn’s ongoing Phase II trial in patients with relapsed/refractory microsatellite stable CRC. CytoDyn recently announced the dosing of the first patient in this study, and is now enrolling additional patients across multiple clinical sites. If the observed results in the previously treated CRC patients are confirmed prospectively, the Company believes leronlimab could be used effectively to treat a wide range of solid tumor types. In addition to its potential as a “stand-alone” agent in oncology, the Company presented exciting evidence of leronlimab’s activity as a “priming” agent for cancer patients with low levels of PD-L1 who were previously unresponsive to, or ineligible for, checkpoint inhibitors at the 2025 ESMO Breast Cancer meeting. The data driving this working theory has shown particular promise in the treatment of patients with advanced metastatic triple-negative breast cancer (“mTNBC”). “At the 2025 ESMO Gastrointestinal Cancers Congress, Dr. Weinberg will share the data and evidence that form the basis for our belief in the potential of leronlimab as a treatment in CCR5 positive solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn. “Our ongoing Phase II trial in patients with mCRC was designed to prospectively confirm these observations, and we look forward to enrolling additional patients as we pursue clinical confirmation of our working theory.” CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including oncology, infectious disease, and autoimmune conditions. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCOImmunotherapy

27 Jun 2025

·www.fiercebiotech.com

CytoDyn must face investor lawsuit alleging misleading claims in COVID, HIV drug debacle

Investors claim that CytoDyn and former key executives mislad shareholders.\n Embattled CytoDyn and key ex-executives must face an investor lawsuit claiming the company knowingly misled shareholders about the status of its FDA application for leronlimab as a potential treatment for HIV and COVID-19.In the lawsuit, former CEO Nader Pourhassan, former chief financial officer Michael Mulholland and Scott Kelly, who previously served as board chairman and chief medical officer, are accused of making false and misleading statements about the company’s lead candidate over the span of two years to boost share prices. Investors, led by shareholder Brian Courter, sued the company and named executives in federal court in Washington State back in 2021 for alleged violations of the Securities Exchange Act.While CytoDyn argued for dismissal, contending that the complaint “ignores the context” in which many statements at issue were made, U.S. District Judge Benjamin H. Settle ultimately disagreed with the company\'s arguments. This week, the judge ruled (PDF) that the claims at issue are plausible, denying CytoDyn\'s motion for dismissal.Courter’s complaint alleges that in April 2020, the executives communicated to CytoDyn investors that the company\'s FDA Biologics License Application for leronlimab in HIV was complete when it was in fact not. The false disclosure spiked the company\'s stock price until the truth was revealed a week later, according to the lawsuit.Later that year, the company claimed that a secondary endpoint in a clinical trial for leronlimab as a COVID-19 treatment showed that the therapy was effective and supported an emergency use authorization (EUA) request to the FDA, according to the lawsuit. CytoDyn later admitted that it had not requested an EUA, despite previously assuring investors that it had, the suit contends.The situation continued through 2022, when executives continued to “falsely represent” that the drug was on a path to FDA approval and wouldn’t need another trial in HIV, the investor lawsuit claims. The FDA placed leronlimab’s development in HIV on a partial pause in 2022, along with a full hold in COVID. CytoDyn’s HIV program escaped the clinical hold in 2024. Under new leadership and a recently established oncology advisory board, the company is still moving forward with leronlimab in various solid tumor uses. New CEO Jacob Lalezari, M.D., made clear in a March letter to shareholders that he believes investors deserve “clear and direct updates” on business matters and that the company’s “collaborative relationship” with the FDA puts it on a “positive trajectory.”Meanwhile, Pourhassan, who led CytoDyn as CEO and president for ten years until being ousted by the board in 2022, was criminally convicted separately in December on four counts of securities fraud, two counts of fraud and three counts of insider trading. The former CEO was convicted alongside the ex-CEO of Amarex Clinical Research, the CRO that managed CytoDyn’s trials and FDA interactions. According to the Department of Justice, Pourhassan netted $4.4 million from CytoDyn’s stock sales during the time of the securities fraud scheme, while former Amarex head Kazem Kazempour made more than $340,000. The sentencing in the cases of Pourhassan and Kazempour has been pushed back to late September 2025.

Executive ChangePatent Infringement

24 Jun 2025

·www.globenewswire.com

CytoDyn Announces First Patient Dosed in Phase II Oncology Trial in Colorectal Cancer

Enrollment is now underway across multiple clinical sites, in partnership with Syneos HealthVANCOUVER, Washington, June 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the first patient has been dosed in the Company’s clinical trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”). In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway. The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance. According to the World Health Organization’s International Agency for Research on Cancer (“IARC”), colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year. The IARC also noted that the incidence rates of colorectal cancer in people younger than 50 years old have been increasing for at least 20 years, with some sources dating the increase trend back 30 years or more. “Dosing the first patient in our Phase II CRC trial is a significant step forward in our mission to bring innovative treatment options to patients facing this challenging disease. This milestone reflects the dedication of our team and clinical partners, and we look forward to advancing this study to better understand the potential impact of our therapy across solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn. The study builds on the Company’s prior research demonstrating the potential clinical benefit of leronlimab in patients with relapsed CRC, and will also further the evaluation of the potential for the Company’s recently announced mechanism of action for leronlimab in solid tumor oncology. Given the promising survival rates observed in the Company’s prior studies in patients with metastatic triple-negative breast cancer and the Company’s ongoing clinical investigation efforts in CRC, CytoDyn views its current line of scientific evaluation as the most expeditious path to determining how broadly applicable this mechanism may prove to be across various solid tumors. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including oncology, infectious disease, and autoimmune conditions. About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Syneos Health brings a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together, Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed its customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how Syneos Health is shortening the distance from lab to life®, visit syneoshealth.com. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com

Phase 2

100 Deals associated with Leronlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11399	Leronlimab	-	DB05941

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	United States	CytoDyn, Inc.	01 Nov 2021
COVID-19	Phase 3	United States	CytoDyn, Inc.	05 Aug 2020
Unresectable Colorectal Carcinoma	Phase 2	United States	CytoDyn, Inc.	30 May 2025
Metastatic Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Microsatellite Stable Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Post Acute COVID 19 Syndrome	Phase 2	United States	CytoDyn, Inc.	01 Mar 2021
Nonalcoholic Steatohepatitis	Phase 2	United States	CytoDyn, Inc.	01 Dec 2020
Triple Negative Breast Cancer	Phase 2	United States	CytoDyn, Inc.	22 Apr 2019
Acute Graft Versus Host Disease	Phase 2	United States	CytoDyn, Inc.	14 May 2017

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04504942 (Phase 2 single-arm basket study, ESMO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma CCR5-positive tumors	5	Leronlimab	kskfbbrxxi(bishplcbnd) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) yedigopjtb (fxxvcaikfy )	Positive	03 Jul 2025
NCT03838367 \| NCT04504942 \| NCT04313075 (ESMO_BC2025)	Not Applicable	Metastatic Triple-Negative Breast Carcinoma CCR5	28	Leronlimab	jldqjcbejy(xqtjdmqfae) = No DLTs were observed in NCT03838367 after dose escalation to 700 mg (n=10) sjhzclmbvz (pjdmfuncvr ) View more	Positive	14 May 2025
NCT04678830 (CTgov)	Phase 2	Post Acute COVID 19 Syndrome	56	Leronlimab (700mg) (700mg Leronlimab)	kkfzfxasji(kwmirglgny) = zibovwkwhz hwvomfifuv (vrvxxwzggi, 13.14) View more	-	11 Apr 2024
				Placebos (Placebo)	kkfzfxasji(kwmirglgny) = ovdapxujzc hwvomfifuv (vrvxxwzggi, 12.27) View more
NCT02737306 (GVHD, CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Graft Versus Host Disease \| Myelodysplastic Syndromes	11	Placebo	wyjctfvwwo(dzondelonu) = npsljgihkd scypvaeycr (sjoqcyiooc, prpnyzuuoa - auycpphdgz) View more	-	12 Mar 2024
NCT02175680 (CTgov)	Phase 2	HIV Infections	43	Historical data+PRO 140	qrjrxcyrac(baxbjmqipd) = gmbrdcyryl iweppgnymx (fcctyturml, 0.71) View more	-	14 Apr 2023
NCT00110591 (CTgov)	Phase 1	HIV Infections	20	PRO 140 (Placebo)	tpkdcvgikg = gsgnddjeop wjdigjgrhk (tlcdihrmos, xicwopqzio - lqtwbllomq) View more	-	14 Mar 2023
				PRO 140 (PRO 140 Dose 1)	tpkdcvgikg = vmwgnwdqvw wjdigjgrhk (tlcdihrmos, airjbptstt - neoztebebp) View more
NCT04521114 (NASH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	87	leronlimab 700 mg (Leronlimab 700 mg)	xlrvbbwzcm(thbvsfsdzi) = oplybxjnrc brdxgawait (vlikstqism, kyhfcmimzd - vcxeokupnt) View more	-	01 Mar 2023
				leronlimab 350 mg (Leronlimab 350 mg)	xlrvbbwzcm(thbvsfsdzi) = fwwkxaodna brdxgawait (vlikstqism, wjgnrmnmwt - tetwxovhec) View more
NCT04343651 (CTgov)	Phase 2	COVID-19	86	Placebo (Placebo)	tqoiifpcap(wkotqfbbpg) = zrazipqnxn kowpxoovyt (ydjyonqhwy, 3.19) View more	-	04 Jan 2023
				Leronlimab (700mg) (700mg Leronlimab)	tqoiifpcap(wkotqfbbpg) = mbrzzaubyf kowpxoovyt (ydjyonqhwy, 3.03) View more
NCT02483078 (PRO140, CTgov)	Phase 2/3	HIV Infections	52	Optimized Background Regimen+PRO 140 (PRO 140)	zfxgekaqyz = jsiqspjjfi gvwqpbypnc (vyviclusfs, vkbmjwloob - xugdiohqkh) View more	-	03 Nov 2022
				Placebo (Placebo)	zfxgekaqyz = oafucuhlvi gvwqpbypnc (vyviclusfs, ckkjzdjeci - toejfjlgmm) View more
NCT03838367 \| NCT04504942 \| NCT04313075 (ASCO2022) Manual	Phase 1/2	Triple Negative Breast Cancer	68	Leronlimab	pvxqxziwmn(hremzubuzc) = yblhbqstjz gwwsxzwfco (uncickwjct, 2.3 - 6.2) View more	Positive	02 Jun 2022

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