A Phase Two Study of 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 Date01 Feb 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

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

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.

01 Nov 2024·CLINICAL THERAPEUTICS

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

Article

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

01 Jan 2024·INTERNATIONAL JOURNAL OF IMMUNOPATHOLOGY AND PHARMACOLOGY

Is preexisting inflamed jaw marrow a “hidden” co-morbidity affecting outcomes of COVID-19 infections? – Clinical comparative study

Article

Author: Bouquot, Jerry E ; Schick, Fabian ; Notter, Florian ; Lechner, Johann ; McMahon, Robert E

Introduction: Exceedingly high levels of the chemokine CCL5/RANTES have been found in fatty degenerated osteonecrotic alveolar bone cavities (FDOJ) and aseptic ischemic osteolysis of the jaw (AIOJ) from toothless regions. Because CCL5/RANTES seems to have a prominent role in creating the COVID-19 “cytokine storm”, some researchers have used the monoclonal antibody Leronlimab to block the CCR5 on inflammatory cells. Objective: Is preexisting FDOJ/AIOJ jaw marrow pathology a “hidden” co-morbidity affecting some COVID-19 infections? To what extent does the chronic CCL5/RANTES expression from preexisting FDOJ/AIOJ areas contribute to the progression of the acute cytokine storm in COVID-19 patients? Methods: Authors report on reducing the COVID-19 “cytokine storm” by treating infected patients through targeting the chemokine receptor 5 (CCR5) with Leronlimab and interrupting the activation of CCR5 by high CCL5/RANTES signaling, thus dysregulating the inflammatory phase of the viremia. Surgical removal of FDOJ/AIOJ lesions with high CCL5/RANTES from patients with inflammatory diseases may be classified as a co-morbid disease. Results: Both multiplex analysis of 249 FDOJ/AIOJ bone tissue samples as well as serum levels of CCL5/RANTES displayed exceedingly high levels in both specimens. Discussion: By the results the authors hypothesize that chronic CCL5/RANTES induction from FDOJ/AIOJ areas may sensitize CCR5 throughout the immune system, thus, enabling it to amplify its response when confronted with the virus. As conventional intraoral radiography does little to assess the quality of the alveolar bone, ultrasonography units are available to help dentists locate the FDOJ/AIOJ lesions in an office setting. Conclusion: The authors propose a new approach to containment of the COVID-19 cytokine storm by a prophylactic focus for future viral-related pandemics, which may be early surgical clean-up of CCL5/RANTES expression sources in the FDOJ/AIOJ areas, thus diminishing a possible pre-sensitization of CCR5. A more complete dental examination includes trans-alveolar ultrasono-graphy (TAU) for hidden FDOJ/AIOJ lesions.

News (Medical) associated with Leronlimab

17 Dec 2024

·www.globenewswire.com

December 2024 Letter to Shareholders

VANCOUVER, Washington, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Dear Shareholders, As I look back on 2024, during which CytoDyn Inc. (“CytoDyn” or the “Company”) achieved multiple crucial milestones, and look forward to 2025 and the exciting developments that lie ahead, I remain truly grateful for your continued support. As described in detail below, we made important progress over the last year and I firmly believe the Company is poised for even more success in the year to come. I am pleased to confirm that the Company has sufficient cash and drug supplies on hand to complete its clinical priorities in 2025. We also continue to make progress on the development of a long-acting formulation of leronlimab that should provide greater patient convenience and help secure additional patent protection for the Company. Since my last update, we have also welcomed several new consultants to the Company, including three key members of our development team. In October, Dr. Melissa Palmer joined as Lead Consultant in Hepatology, leveraging her expertise to help guide the development of leronlimab in the treatment of MASH and liver fibrosis. We also welcomed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development, capitalizing on his significant pharmaceutical experience and connections to help oversee the Company’s global research and development strategy, as well as to support our programs in inflammation and HIV. In November, Dr. Richard Pestell joined as Lead Consultant in Oncology to support our programs in colorectal cancer (CRC), triple-negative breast cancer (TNBC) and glioblastoma (GBM). The addition of this team of seasoned experts and top-tier consultants should enable CytoDyn to capitalize on our positive momentum, push our clinical development pipeline forward and make 2025 a pivotal year for the Company. I believe our current strategy will result in significant value return to the Company and its shareholders and should give us the opportunity to do so on an abbreviated timeline. We are on good terms with the FDA, we have the funds required to pursue our key development objectives and we have the requisite expertise and associations to execute on our vision. Entering 2025, the Company is in control of its own destiny. Shareholders are the lifeblood of the Company, and we remain committed to acting in your best interests. We will continue to take one thoughtful step at a time to hit our milestones and, in turn, drive value for our shareholders. It is my pleasure to provide a detailed update on some exciting new developments with this letter. My dedication to CytoDyn continues to be grounded in my core belief that leronlimab has the potential to be a life-changing therapeutic. I remain fully committed to the mission of bringing value to our shareholders and to completing studies that will unequivocally demonstrate the impact of leronlimab in the clinic. Thank you again for your patience, support and trust. Best wishes to all for this holiday season. As we enter 2025, I am truly excited about the possibilities that lie just ahead. With Gratitude, Jacob Lalezari, MDCEO Oncology – December 2024 Update The Company will be prioritizing oncology in 2025, as we believe this indication holds the potential for the highest value return to the Company in the form of a significant partnership and/or drug approval. As recently announced, CytoDyn has received FDA clearance to initiate a Phase II study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). As noted in our prior release, we recently completed the kickoff meeting with Syneos Health, the CRO for the study, and enrollment efforts are set to begin in January. I am also delighted to announce that Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance has agreed to be the lead Principal Investigator for the CRC study. As requested by the FDA, the first five patients enrolled in this study will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and Bevacizumab. After a preliminary safety review, subsequent patients will then be randomized to 350 or 700 mg of weekly leronlimab with the same background regimen. The Data and Safety Monitoring Board (DSMB) will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy. The DSMB can then recommend restricting further enrollment to a single dose level, should they identify a signal of superior activity in either one of the treatment arms. For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here: (https://clinicaltrials.gov/study/NCT06699836?cond=colorectal%20cancer&intr=leronlimab&rank=1). CytoDyn also remains focused on the possible role for leronlimab in TNBC. As previously announced, we are launching two preclinical studies in TNBC that will seek to further clarify the mechanism of action of leronlimab in oncology and identify potential treatment synergies to optimize the design of a follow-up clinical study. Lastly, the Company remains focused on the possible use of leronlimab in the treatment of GBM. Preliminary results from a preclinical study performed at the Albert Einstein College of Medicine do not appear to show a difference in outcome with leronlimab compared to the control arm. The Company has committed to repeating the study based on unpublished observations by Dr. Pestell’s lab and will now employ a treatment sequence involving temozolomide and leronlimab. This follow-up study will start immediately and should help clarify the potential therapeutic benefit of leronlimab in the treatment of GBM. CytoDyn is also currently in discussions with a key opinion leader in neuro-oncology about the possibility of initiating a pilot study in patients with GBM based on Dr. Pestell’s unpublished work and the outcome of the follow-up preclinical study. Inflammation – December 2024 Update We continue to believe that treatment of inflammation with leronlimab remains a viable and important development pathway, and we are moving forward in three indications associated with chronic inflammation on a cost-efficient basis. First, CytoDyn previously announced exciting results from an initial preclinical study with SMC Laboratories evaluating leronlimab in the treatment of a mouse model of MASH. The results from this preliminary study demonstrated that high dose leronlimab was significantly better at reversing liver fibrosis compared to an IgG 4 isotype control and demonstrated a trend toward better fibrosis reversal compared to Resmetirom. The final results from that study have now also demonstrated that leronlimab (both high and low dose) was significantly better than Resmetirom at reversal of fat deposition (steatosis) in the liver. These exciting findings have been submitted as a late breaker abstract to the MASH TAG conference and, if accepted, will be presented at the meeting in January. In September, CytoDyn launched two follow up studies to confirm and expand on these preliminary results. The first follow-up study seeks to confirm the observations of the original study with larger cohorts of mice (12 versus the original 8/group) and will compare leronlimab with a GLP-1 agonist (Semaglutide) in addition to confirming the comparisons with Resmetirom. The second follow-up study involves the administration of CCL4, a drug that directly causes liver fibrosis in mice. This study will clarify if the observed reversal of liver fibrosis is restricted to the MASH/fat deposition pathway or might occur independently of the etiology of fibrosis (e.g. alcohol, viral hepatitis, etc.). The results from both follow-up studies will become available in January. As a side note, we have been contacted by colleagues at a major academic institution who indicated that, if the liver fibrosis reversal results are confirmed in the follow-up studies, they would be interested in funding a pilot study of leronlimab in the treatment of patients with pulmonary fibrosis at their own center. Second, in September, CytoDyn applied to the NIH/RECOVER-TLC group for the potential inclusion of leronlimab in their next round of Long Covid treatment studies. We expect to learn the group’s decision in the next several months. In the meantime, we have paused the launch of our previously announced pilot study in patients with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) since the two conditions (Long Covid and ME/CFS) essentially overlap. If the RECOVER-TLC team decides to move forward with leronlimab, we will formally suspend the ME/CFS study. If the RECOVER-TLC team declines to include leronlimab, we will resume the pursuit of a pilot study in patients with ME/CFS, for which we already have a draft protocol synopsis and lead investigator identified. Third, we have finalized the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s disease. That study will take place at Cornell Medical Center in New York and will evaluate an objective neuroradiology primary endpoint that will provide a clear measure of leronlimab’s potential role in treating Alzheimer’s disease. I am pleased to announce the study is now fully funded by an outside foundation, and the protocol will soon be submitted to both the FDA and the Cornell IRB. Other – December 2024 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 study will employ leronlimab to protect CCR5+ donor immune cells from HIV infection, while aiming for a cure in the setting of bone marrow transplant to an HIV+ recipient. We are confident in the likelihood of success of the LATCH program, given the announcement over the summer by investigators in Germany of a successful cure using donor cells from an individual who was heterozygous for the CCR5-delta 32 mutation. Indeed, those same investigators have asked CytoDyn if they too can run the LATCH study at their research center in Berlin. The LATCH protocol is scheduled to complete final updates at the end of December, and we look forward to the launch of this program in 2025. CytoDyn has also continued to prioritize the publication of our existing clinical data. The CD10 manuscript describing the trial of patients with mild to moderate COVID-19 was recently published in Clinical Therapeutics. The manuscript for the CD02 Phase 3 study in patients with multi-drug-resistant HIV has also just been accepted for publication by the Journal of Acquired Immune Deficiency Syndromes (JAIDS). The Company is pursuing publication of four additional manuscripts, including the CD12 manuscript (severe and critical COVID-19), twin papers on the TNBC study results, and the MASH manuscript. Those submissions were delayed by various obstacles but are now moving forward. In addition, CytoDyn is preparing a draft manuscript summarizing the integrated safety data from the almost 1,600 patients who have now been treated with leronlimab. The final draft of that manuscript will go out for author review in the coming weeks and will be submitted for peer review shortly thereafter. 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

30 Oct 2024

·www.globenewswire.com

CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC Laboratories

VANCOUVER, Wash., Oct. 30, 2024 (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, announced today that Dr. Melissa Palmer, M.D., has been engaged as Lead Consultant in Hepatology. In this role, Dr. Palmer will drive the Company’s strategy for research and development in Hepatology, leveraging her expertise to further CytoDyn’s clinical evaluation of leronlimab in treating liver conditions, including MASH and liver fibrosis. This engagement follows the recent breakthroughs with SMC Laboratories (“SMC”). In addition, the Company announced that following promising initial results from its preclinical study with SMC, it has commissioned the lab to conduct two follow-up studies to confirm and extend the observation of fibrosis reversal observed in the study concluded in September 2024. Both follow-up studies are underway, with results expected in early 2025. An internationally renowned hepatologist, Dr. Palmer brings more than three decades of deep research experience to the CytoDyn team. She has held leadership positions at several biotech and pharmaceutical companies, including serving as Chief Medical Officer of Gannex/Ascletis and Head of Liver Disease at Takeda Pharmaceutical Company. She has also worked as a hepatology consultant with over 60 biotech and pharmaceutical companies since 1991 and previously served as interim Chief Medical Officer of CytoDyn. In addition to consulting, Dr. Palmer has been the primary investigator for numerous clinical trials in MASH and other liver diseases. Her work has been published in over 100 publications, abstracts, manuscripts, books and book chapters, including several guidelines she co-authored with colleagues from the FDA and EMA concerning drug-induced liver injury among patients in clinical trials evaluating potential drugs to treat MASH and other liver diseases. She also maintained a solo medical practice treating patients with liver disease for over 20 years. Dr. Palmer will work with the CytoDyn team to oversee the two follow-up studies with SMC. These studies will again compare leronlimab alone and in combination with other therapies, including both resmetirom, the only approved treatment for MASH, and a GLP-1 agonist in an increased number of mice evaluated in both a proprietary STAM model of MASH which includes T2DM (previously studied), as well as a second model of liver fibrosis driven by CCL4 toxicity that is independent of fat deposition. “As we continue to capitalize on our momentum and push forward the path of scientific discovery here at CytoDyn, we are pleased to welcome Dr. Palmer to the team,” said Dr. Jacob Lalezari, CEO. “Dr. Palmer’s robust research and consulting background, and past familiarity with CytoDyn, will provide the tailored expertise we need to maximize opportunities to pursue breakthroughs in new treatment paths for MASH and liver fibrosis.” Dr. Palmer added, “This is an exciting time in liver health research, as scientific innovation paves the way for improved treatments for conditions like MASH and liver fibrosis. I look forward to collaborating with the CytoDyn team to advance clinical evaluations of leronlimab, including the studies in motion, and explore new treatments that have the potential to truly transform patient outcomes.” Dr. Palmer trained in Hepatology at Mount Sinai School of Medicine, where she also received her M.D. degree. She also holds a B.S. from Columbia University and is a Fellow of the American Association for the Study of Liver Diseases. 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. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH. About SMC Laboratories SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse' animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details. Note Regarding Forward-Looking StatementsThis 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 in Item 1A. 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

Executive Change

07 Oct 2024

·www.globenewswire.com

CytoDyn Announces Abstract that Highlights Leronlimab’s Potential in Mediating ART-Free Viral Control in Infant Rhesus Macaques

Abstract to be presented at the 5th annual HIV Research for Prevention Conference Study results highlight potential for treatment VANCOUVER, Washington, Oct. 07, 2024 (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 acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract summarizes research on the potential of combining early antiretroviral therapy (ART) with a novel immunotherapy approach using broadly neutralizing antibodies (bNAbs) and leronlimab. This innovative treatment strategy was evaluated in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV), offering promising insights into treatment possibilities to achieve viral control without the need for continuous ART. Key Highlights of the Study: Objective: To assess whether a combination of early ART initiation with bNAbs and leronlimab can provide sustained viral control in infant rhesus macaques, potentially reducing or eliminating the need for lifelong daily medication.Methodology: Eighteen (18) infant rhesus macaques were infected with SHIV and then treated with various combinations of ART, bNAbs, and leronlimab. The study evaluated the efficacy of these treatments over a 27-week period, followed by a treatment interruption to monitor virus rebound.Results: The combination of ART, bNAbs, and leronlimab showed promising results, with no virus rebound observed in any of the treated animals, suggesting a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART. “These results demonstrate a previously unappreciated synergy between CCR5 blockade and antibody neutralization that opens the door to a new approach for an HIV cure that should be explored further,” said Jonah B. Sacha, Ph.D, Chief of the Pathobiology and Immunology Division at the Oregon National Primate Research Center at Oregon Health & Science University. The study was funded by an NIH grant awarded to OHSU and led by Dr. Nancy Haigwood, Dr. Sacha, and their collaborators. “We are proud to report these results as we continue to progress our clinical development pipelines for leronlimab across a number of clinical indications,” said Dr. Jay Lalezari, CEO of CytoDyn. “The potential for a treatment path for HIV utilizing leronlimab that allows for long-lasting viral control and potentially reduces or eliminates the need for ongoing ART is a thrilling prospect. We’re grateful to our partners at Oregon Health & Science University and look forward to continuing this important work.” Dr. Sacha will present the abstract at the 5th annual HIV Research for Prevention Conference in Lima, Peru. Details on the presentation are shown below. Title: Short-term combination immunotherapy with broadly neutralizing antibodies and CCR5 blockade mediates ART-free viral control in infant rhesus macaquesPresentation Type: Oral abstract sessionSession Title: Planet of the Apes: Learning immunogenicity from animal modelsSession Date and Time: October 10, 2024, 5:30-7:00PM PET 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. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH. Note Regarding Forward-Looking StatementsThis 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 in Item 1A. 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

Clinical StudyImmunotherapyClinical Result

100 Deals associated with Leronlimab

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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	US	CytoDyn, Inc.	01 Nov 2021
COVID-19	Phase 3	US	CytoDyn, Inc.	05 Aug 2020
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	US	CytoDyn, Inc.	01 Mar 2021
Nonalcoholic Steatohepatitis	Phase 2	US	CytoDyn, Inc.	01 Dec 2020
Solid tumor	Phase 2	US	CytoDyn, Inc.	01 May 2020
Triple Negative Breast Cancer	Phase 2	US	CytoDyn, Inc.	22 Apr 2019
Acute Graft Versus Host Disease	Phase 2	US	CytoDyn, Inc.	14 May 2017

Clinical Result

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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)	xtgbzzfuey(gfurexgjiy) = jydtmongkh zxjmyokxwp (fcdkcxquvd, qjeqryxjgz - xxdwnmpnpj) View more	-	11 Apr 2024
				Placebos (Placebo)	xtgbzzfuey(gfurexgjiy) = rliutpyrzi zxjmyokxwp (fcdkcxquvd, fnodfrtiol - ppvewqiypy) View more
NCT02737306 (GVHD, CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Graft Versus Host Disease \| Myelodysplastic Syndromes	11	Placebo	pfpubozmak(ffahjrlare) = dxobpycpwk utxihwsqas (xralzudgzv, grvttfpeut - agyvbcxkbk) View more	-	12 Mar 2024
NCT02175680 (CTgov)	Phase 2	HIV Infections	43	Historical data+PRO 140	dmzsotnvpp(kcuqjptfrm) = cummdqcusc bsqlhhayai (zxczlwijkl, yzaaydcqgd - sasgfgupvf) View more	-	14 Apr 2023
NCT00110591 (CTgov)	Phase 1	HIV Infections	20	PRO 140 (Placebo)	efvueggliq(pgnsdwrypi) = gibrzcgmeq mssahwilye (poggguorhx, gfjhqdzxzw - yyrxsjviad) View more	-	14 Mar 2023
				PRO 140 (PRO 140 Dose 1)	efvueggliq(pgnsdwrypi) = sptrhkesng mssahwilye (poggguorhx, hxixbmwlgv - dlcfwcwfun) View more
NCT04521114 (NASH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	87	leronlimab 700 mg (Leronlimab 700 mg)	kgocuwuhss(yqzbcqjzki) = zzomjhdhie xytiqdgknx (qknxjbzywi, djpnkktwnf - pczaapcljc) View more	-	01 Mar 2023
				leronlimab 350 mg (Leronlimab 350 mg)	kgocuwuhss(yqzbcqjzki) = wltbasbgrd xytiqdgknx (qknxjbzywi, ilnnnvrddd - xvpcgqhohj) View more
NCT04343651 (CTgov)	Phase 2	COVID-19	86	Placebo (Placebo)	gcdlokqrdz(ubovzjubvs) = soahcwiuht xrxldeuqkg (pnjydnbwou, wxlwuhmwut - rxrgquscxp) View more	-	04 Jan 2023
				Leronlimab (700mg) (700mg Leronlimab)	gcdlokqrdz(ubovzjubvs) = spvhbbsreu xrxldeuqkg (pnjydnbwou, cvfsbgbfiv - ebbhkmfczn) View more
NCT02483078 (PRO140, CTgov)	Phase 2/3	HIV Infections	52	Optimized Background Regimen+PRO 140 (PRO 140)	neabxxgvol(zxaryudsvq) = qakyfnztyu kinbhjrcug (crrfrdpskv, jgiadixdji - bqtuurbaxh) View more	-	03 Nov 2022
				Placebo (Placebo)	neabxxgvol(zxaryudsvq) = sukawbpnnk kinbhjrcug (crrfrdpskv, krolbfdlzu - tafsejaber) View more
NCT03838367 \| NCT04504942 \| NCT04313075 (ASCO2022) Manual	Phase 1/2	Triple Negative Breast Cancer	68	Leronlimab	gydkicuckh(kioncumcej) = vspyajpcnt rzmsrphzoy (fkcqhfntma, 2.3 - 6.2) View more	Positive	02 Jun 2022
NCT03838367 (GlobeNewswire) Manual	Phase 1/2	Triple Negative Breast Cancer triple-negative	30	Carboplatin+leronlimab	nztwenclbs(veqhvaegjh) = kfpycgffqm qppigusfme (lhrajdiljp ) View more	Positive	19 Jul 2021
NCT00613379 (CTgov)	Phase 2	HIV Infections	30	PRO 140 (Arm 1)	xdonfiynbn(crlgyqyaqf) = ltnbvngkxn kwkmtoxcxb (bxuwqgrlet, nmfxptowfl - neouweaghl) View more	-	31 May 2013
				PRO 140 (Arm 2)	xdonfiynbn(crlgyqyaqf) = ddwkjkiuek kwkmtoxcxb (bxuwqgrlet, kbhhayoktc - qgsxipnijg) View more

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