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.

144

News (Medical) associated with Leronlimab

29 Apr 2025

·www.globenewswire.com

CytoDyn Leadership Team To Attend ESMO Breast Cancer Meeting in Munich, Germany

Dr. Jacob Lalezari, CEO, and Dr. Richard Pestell, Lead Consultant in Preclinical and Clinical Oncology, to lead CytoDyn group in attendance VANCOUVER, Washington, April 29, 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, is pleased to announce that the Company will be presenting a poster at the upcoming European Society for Medical Oncology’s (“ESMO”) Breast Cancer meeting, following its promising survival observations among patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. The conference will take place on May 14-17, 2025, in Munich, Germany, and CytoDyn’s presentation is scheduled for May 15, 2025. As announced in February 2025, a review of patients treated with leronlimab during CytoDyn’s prior clinical trials in oncology revealed observed survival rates at 12, 24, and 36 months that compare favorably to expected outcomes with currently approved therapies. The Company has also now confirmed survival outcomes in a group of patients with mTNBC and four prior lines of treatment who are alive more than 48 months after receiving leronlimab. This includes four patients who currently identify as having no evidence of ongoing disease and a fifth patient who is alive with stable disease. CytoDyn has already initiated a follow-up protocol to continue to monitor these surviving patients into the future. “We look forward to sharing details on the progress we have made advancing our clinical development pipeline for leronlimab in oncology,” said Dr. Lalezari. “We are also excited to share information about the apparent mechanism of action in long-term surviving patients that we see as a potentially paradigm-shifting development in solid tumor oncology.” Dr. Lalezari will be joined at the conference by Dr. Richard Pestell, MD, PhD, AO, Lead Consultant in Preclinical and Clinical Oncology, who will present during the poster display session in Hall B0 on Thursday, May 15 from 12:00-12:45PM CEST. Several other CytoDyn key opinion leaders will also be attending the conference. 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. Note Regarding Forward-Looking Statements This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and Item 1A Risk Factors, and our Quarterly Report on Form 10-Q for the fiscal quarter ended February 28, 2025. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com

ASCO

27 Mar 2025

·www.prnewswire.com

LifeTracDx® Blood Test to be Performed in Key Colorectal Clinical Trial

MONMOUTH JUNCTION, N.J., March 27, 2025 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. (Creatv) will be collaborating with CytoDyn Therapeutics Corporation (CytoDyn) to assess patient response to their drug using the LifeTracDx® blood test. CytoDyn has received FDA clearance to initiate a Phase II study of leronlimab in patients with relapsed or refractory micro-satellite stable colorectal cancer (CRC) (NCT06699835). The drug, leronlimab, targets CCR5 marker on the tumor. Creatv will perform the LifeTracDx® liquid biopsy in a number of CytoDyn studies including NCT06699835. The LifeTracDx® test is based on analyzing two biomarkers: (1) circulating tumor cells (CTCs) and (2) Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells. Both CTCs and CAMLs contain tumor material. By tracking CTC and CAML counts, and CAML size at various time points, LifeTracDx® can provide prognostic insights and predict treatment response. CytoDyn is also interested in the expressions of CCR5 and PD-L1 markers on the tumor. These markers can change over time. LifeTracDx® can provide this information by a blood test - no tissue is required. The LifeTracDx® assay will help CytoDyn to better evaluate the effectiveness of their drug. About Creatv Bio Creatv Bio is a cancer screening and cancer diagnostics company providing testing services to patients and pharma companies to support drug development from its laboratory in NJ. Creatv's scientists were the first to publish on CAMLs found in the blood of cancer patients. LifeTracDx® blood tests have many applications including predicting response to a new therapy in just 30 days, providing companion diagnostics such as PD-L1 and drug targets using blood instead of tissue, providing information about aggressiveness of the cancer, detection of minimal residual disease, early detection of cancer recurrence, and cancer screening. For a complete listing of our journal publications and posters, please visit our website at . For more information contact: SOURCE Creatv MicroTech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

18 Mar 2025

·www.globenewswire.com

March 2025 Letter to Shareholders

VANCOUVER, Washington, March 18, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As envisioned, 2025 is unfolding to be an exciting year for CytoDyn Inc. (“CytoDyn” or the “Company”). On February 24, 2025, the Company announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (“mTNBC”) who were treated with leronlimab in prior CytoDyn-sponsored studies. The impressive survival observations at 12, 24, and 36 months in patients who previously failed treatment in the metastatic or locally advanced setting indicate leronlimab could play a significant role as a paradigm-shifting therapeutic in oncology. Of particular interest, we identified a subgroup of these patients who remain alive and well today and currently identify as cancer-free. This is only the beginning of the Company’s 2025 oncology story. We are eager to provide updates in the coming months as they are available to share. There is still much work to be done, but I am encouraged by what is on the near horizon. I’d like to offer a word of deep gratitude to the CytoDyn team and the key opinion leaders (“KOLs”) who worked so diligently these last months to bring these data together. I would also like to reiterate my appreciation for you – the shareholders. Our business priorities are (i) getting leronlimab to patients in need; and (ii) generating value for our dedicated shareholders. As a long-time supporter of the company and now CEO, I believe investors deserve clear and direct updates as it relates to milestones, regulatory process, and finances. We will continue to incorporate this principle into our messaging as we move forward, presenting a clear picture of where we stand in the development pipeline and celebrating major milestones together. Looking ahead, we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors, as well continued updates relating to the Colorectal Cancer (“CRC”) trial, as further described below. In terms of the regulatory process, I am confident that our collaborative relationship with the FDA has placed us on a positive trajectory. To accelerate progress in oncology where feasible, we’re establishing an oncology advisory board to ensure we are exploring the fastest and most responsible pathway(s) forward. We will continue to look for opportunities to solicit feedback regarding our development process from both KOLs and the FDA. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we chart our future course. The Company continues to be on track financially and we forecast sufficient cash and drug supply on hand to advance our clinical priorities in 2025. As we approach key milestones and announcements in the coming months, we’ll evaluate opportunities to raise additional funds at optimal times and through methods that best serve the Company and its shareholders. We believe leronlimab has already established the potential for tremendous value in the clinic, and in the coming months we look forward to sharing the basis for that conclusion. In sum, the developments in oncology have set the stage for 2025 to be a benchmark year for CytoDyn. This is no longer a platform drug in search of an indication; we now have compelling data to support a role for leronlimab in solid-tumor oncology and are executing on that vision. With Gratitude, Jacob Lalezari, MDCEO Oncology – March 2025 Update The Company continues to prioritize oncology in 2025, as we believe this indication holds the highest potential and shortest timeline for return on investment in the form of a partnership or drug approval. The exciting survival outcomes announced in February 2025 provide early clinical evidence of leronlimab’s potential impact across the field of solid-tumor oncology. As previously announced, we’ve submitted our findings as an abstract to the European Society for Medical Oncology meeting in Munich, Germany in May 2025. We are eager to share additional insights into the apparent mechanism behind the survival outcomes and will do so once appropriate and in compliance with pre-conference publication and announcement allowances. In the meantime, CytoDyn has initiated a follow-up protocol so we can continue to monitor the surviving patients into the future. The CytoDyn/Syneos study teams have now approved eight clinical sites and counting to participate in CytoDyn’s Phase II study of patients with CRC and refractory disease. These clinical sites will include a mix of both large community practices as well as academic centers which all have well-established track records of superior work and high enrollment. With our clinical trial agreements in place and study initiation visits about to start, we expect screening of patients into the CRC study to commence shortly. As previously mentioned, Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance will be the lead Principal Investigator for the CRC study. Per the FDA’s request, the first five patients enrolled will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and bevacizumab. After a preliminary safety review by the Data and Safety Monitoring Board (“DSMB”), subsequent patients will be randomized to 350 or 700 mg of weekly leronlimab along with the same background regimen. The DSMB will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy and can then recommend restricting further enrollment to a single dose level, if deemed appropriate. For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here. In concert with the observation of prolonged survival in patients with mTNBC described above, CytoDyn remains focused on expeditiously resuming our clinical development in this indication. Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway. A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths. In the meantime, we will continue discussions with KOLs about the possibility of initiating a follow-up study in patients with mTNBC on an abbreviated timeline, based on currently available data. The Company also continues to explore the possible use of leronlimab in the treatment of glioblastoma multiforme (“GBM”). A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway. CytoDyn is also in discussions with several KOLs in neuro-oncology about the possibility of initiating a pilot study in patients with GBM, also based on currently available data. Inflammation – March 2025 Update As previously announced, CytoDyn applied to the NIH/RECOVER-TLC group for the inclusion of leronlimab in their next round of Long Covid treatment studies. The shifting policy landscape in the United States has created some uncertainty around government-sponsored funding of research, but we have been informed by a member of the RECOVER team that their review process has resumed, and we expect a decision soon. In addition, the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s Disease (“AD”) is now finalized. The study will take place at Cornell Medical Center in New York and will evaluate a neuroradiology endpoint that should provide a clear signal of leronlimab’s potential role in treating AD. The study is fully funded, and our colleagues at Cornell are engaged to move the project forward through Cornell’s institutional review process and FDA submission. A new collaborator, Dr. Tom Carmichael, Professor and Chair of Neurology at the University of California, Los Angeles, has published important preclinical observations demonstrating how a small molecule CCR5 inhibitor can expedite recovery following a cerebrovascular accident (“CVA” or “stroke”). CytoDyn is working with Dr. Carmichael and Dr. Kate Schunke at the University of Hawaii to conduct a preclinical study of stroke in transgenic mice that express human CCR5. We are excited by this initiative, given our view that there is an unmet need for innovative and effective treatment paths for patients in this category, and our belief that the market for therapies to treat stroke and/or traumatic brain injury could grow significantly over the next several decades. Dr. Carmichael will also be advising on the pilot study of AD to be initiated at Cornell Medical Center in New York. As announced via press release on February 6, 2025, the final results from SMC Laboratories (“SMC”) indicated statistically significant reversal of liver fibrosis (p< 0.01) in all 3 studies conducted at SMC. Importantly, the reversal of fibrosis appears to be independent of the mechanism of liver insult, as the effect was seen in both metabolic-dysfunction associated steatohepatitis (“MASH”) and CCL4 models of liver injury. To call attention to a key point of clarification, the final results at SMC did not confirm a significant effect of leronlimab on fat accumulation in the liver in the MASH model. Given this observation, we will pause development efforts related to MASH in the near term. Instead, we are continuing discussions with potential partners who have expressed interest in funding studies of leronlimab in the treatment of patients with organ fibrosis to build on the promising findings listed above. Other – March 2025 Update As previously announced, CytoDyn is partnering with the American Foundation for AIDS Research (“amfAR”) to sponsor an HIV cure study called LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV). The clinical teams at Oregon Health and Sciences University and the University of Washington remain confident in the chances of success of their LATCH protocol and we look forward to the launch of this program in 2025. CytoDyn continues to prioritize the publication of our clinical data. The exciting observation of improved survival in patients with mTNBC treated with leronlimab has naturally prompted us to reframe the focus of our oncology manuscripts. Submission of these oncology manuscripts for peer review is a top publication priority. Additional ongoing publication efforts include: The manuscript for our CD02 Phase 3 study in patients with multi-drug-resistant HIV was recently published by the Journal of Acquired Immune Deficiency Syndromes and has been posted to our website.The manuscripts for the CD12 Acute Covid and MASH clinical studies are in final preparation for submission.A manuscript summarizing the results of treatment with leronlimab on liver fibrosis from SMC is in preparation.As previously announced, CytoDyn is preparing a manuscript summarizing the integrated safety data from the almost 1,600 patients who have already received leronlimab. The final draft of that safety summary will be completed shortly. Note Regarding Forward-Looking Statements This letter contains forward-looking statements relating to, among other things, clinical drug development and research strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements,” and in Part I, Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statements as a result of new information or future events or developments other than as required by law. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com

Phase 2Phase 3

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

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04678830 (CTgov)	Phase 2	Post Acute COVID 19 Syndrome	56	Leronlimab (700mg) (700mg Leronlimab)	owdjafaymh(ovpguznorp) = yrvvuothjt agmcmvsegb (jrmkdrzkwh, 13.14) View more	-	11 Apr 2024
				Placebos (Placebo)	owdjafaymh(ovpguznorp) = kvlktaxwsa agmcmvsegb (jrmkdrzkwh, 12.27) View more
NCT02737306 (GVHD, CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Graft Versus Host Disease \| Myelodysplastic Syndromes	11	Placebo	wsqseovuxf(cjnaiyriql) = tnowgirjfg awnypmwqyo (bpajgbugik, qgfsijhtqx - lciyxkbsqr) View more	-	12 Mar 2024
NCT02175680 (CTgov)	Phase 2	HIV Infections	43	Historical data+PRO 140	acbjskqzyc(qprlpnqdsm) = sgvtooikww eyymgggwxg (veuklyvkew, 0.71) View more	-	14 Apr 2023
NCT00110591 (CTgov)	Phase 1	HIV Infections	20	PRO 140 (Placebo)	nrvknetjcm = gotqwmojjq xzzujqzroc (rzfiahdnvd, nhjwshgnep - vkgumnanqj) View more	-	14 Mar 2023
				PRO 140 (PRO 140 Dose 1)	nrvknetjcm = zvgzfrqwus xzzujqzroc (rzfiahdnvd, yognhopvtd - ajeqvqzrtm) View more
NCT04521114 (NASH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	87	leronlimab 700 mg (Leronlimab 700 mg)	ulcdhjarao(heqvooxzjn) = rzaojvckxw ojyblwdguu (aqqtfmnewn, knfdoswyue - vitgicszol) View more	-	01 Mar 2023
				leronlimab 350 mg (Leronlimab 350 mg)	ulcdhjarao(heqvooxzjn) = aggjdyttje ojyblwdguu (aqqtfmnewn, dwjgminjaa - qwbdzvvnob) View more
NCT04343651 (CTgov)	Phase 2	COVID-19	86	Placebo (Placebo)	zbjweyfcat(fpfnkkqrni) = ocrjbgqezn fvybpzfowo (ktjupzdemx, 3.19) View more	-	04 Jan 2023
				Leronlimab (700mg) (700mg Leronlimab)	zbjweyfcat(fpfnkkqrni) = gmmpvdsfcl fvybpzfowo (ktjupzdemx, 3.03) View more
NCT02483078 (PRO140, CTgov)	Phase 2/3	HIV Infections	52	Optimized Background Regimen+PRO 140 (PRO 140)	lypwbrbsfv = efyydoekxm tiqnuzlqgp (tvdoqmavpq, bekibdssqa - dhycgmiiep) View more	-	03 Nov 2022
				Placebo (Placebo)	lypwbrbsfv = qdgywnyoum tiqnuzlqgp (tvdoqmavpq, ilpphmrswr - acoukicepw) View more
NCT03838367 \| NCT04504942 \| NCT04313075 (ASCO2022) Manual	Phase 1/2	Triple Negative Breast Cancer	68	Leronlimab	quiimznsyh(ebjqcwccme) = dcbmdoriec gvmqixbxcj (sqmtxjzivh, 2.3 - 6.2) View more	Positive	02 Jun 2022
SABCS2022	Not Applicable	Triple Negative Breast Cancer	-	Leronlimab	tfdwzluzam(ytmjabkdwv) = n=2 cjuufafwma (ylemduhqwm ) View more	-	15 Feb 2022
NCT03838367 (GlobeNewswire) Manual	Phase 1/2	Triple Negative Breast Cancer triple-negative	30	Carboplatin+leronlimab	xhlidsrrxp(ljuotawfhn) = syivnxrzdf sjgjjgfkta (nzesnknswo ) View more	Positive	19 Jul 2021

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