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: Van Rompay, Koen K A ; Sacha, Jonah B ; Magnani, Diogo M ; Usachenko, Jodie L ; Schiffer, Celia A ; Shaqra, Ala M ; Zikos, Joanna ; Webb, Gabriela M ; Wu, Helen L ; Reed, Jason S ; 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: Sacha, Jonah B. ; Loftus, Richard ; Hansen, Scott G ; Sacha, Jonah B ; Sammartino, Daniel ; Ogbuagu, Onyema ; Yang, Otto O ; Lalezari, Jacob P ; Ojha, Sohita ; Yang, Otto O. ; Seethamraju, Harish ; Hansen, Scott G. ; Arman, Arvin Cyrus ; Lalezari, Jacob P. ; Mansour, Ali

PURPOSEEarly 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.METHODSThe 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).FINDINGSOverall, 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%).IMPLICATIONSAt 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.CLINICALTRIALSgov number, NCT04343651 https://classic.CLINICALTRIALSgov/ct2/show/NCT04343651.

07 Feb 2024·Antimicrobial Agents and Chemotherapy

NorA efflux pump mediates Staphylococcus aureus response to Pseudomonas aeruginosa pyocyanin toxicity

Article

Author: Hooper, D. C. ; Lawton, B. G. ; Wang, Y. ; Truong-Bolduc, Q. C. ; Yonker, L. M.

ABSTRACT Endogenous transporters protect Staphylococcus aureus against antibiotics and also contribute to bacterial defense from environmental toxins. We evaluated the effect of overexpression of four efflux pumps, NorA, NorB, NorC, and Tet38, on S. aureus survival following exposure to pyocyanin (PYO) of Pseudomonas aeruginosa , using a well diffusion assay. We measured the PYO-created inhibition zone and found that only an overexpression of NorA reduced S. aureus susceptibility to pyocyanin killing. The MIC PYO of the NorA overexpressor increased threefold compared to that of wild-type RN6390 and was reduced 2.5-fold with reserpine, suggesting that increased NorA efflux caused PYO resistance. The PYO-created inhibition zone of a ΔnorA mutant was consistently larger than that of a plasmid-borne NorA overexpressor. PYO also produced a modest increase in norA expression (1.8-fold at 0.25 µg/mL PYO) that gradually decreased with increasing PYO concentrations. Well diffusion assays carried out using P. aeruginosa showed that ΔnorA mutant was less susceptible to killing by PYO-deficient mutants PA14 phzM and PA14 phzS than to killing by PA14. NorA overexpression led to reduced killing by all tested P. aeruginosa . We evaluated the NorA–PYO interaction using a collection of 22 clinical isolates from adult and pediatric cystic fibrosis (CF) patients, which included both S. aureus (CF-SA) and P. aeruginosa (CF-PA). We found that when isolated alone, CF-PA and CF-SA expressed varying levels of PYO and norA transcripts, but all four CF-PA/CF-SA pairs isolated concurrently from CF patients produced a low level of PYO and low norA transcript levels, respectively, suggesting a partial adaptation of the two bacteria in circumstances of persistent co-colonization.

102

News (Medical) associated with Leronlimab

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

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

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

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	Phase 3	United States	CytoDyn, Inc.	01 Nov 2021
COVID-19	Phase 3	United States	CytoDyn, Inc.	05 Aug 2020
HIV Infections	Phase 2	United States	CytoDyn, Inc.	01 Nov 2021
Acute Graft Versus Host Disease	Phase 2	United States	CytoDyn, Inc.	14 May 2017
Acute Myeloid Leukemia	Phase 2	United States	CytoDyn, Inc.	14 May 2017
Myelodysplastic Syndromes	Phase 2	United States	CytoDyn, Inc.	14 May 2017
HIV Infections	Discovery	United States	CytoDyn, Inc.	01 Nov 2021
Nonalcoholic Steatohepatitis	Discovery	United States	CytoDyn, Inc.	01 Dec 2020
Solid tumor	Discovery	United States	CytoDyn, Inc.	01 May 2020
Triple Negative Breast Cancer	Discovery	United States	CytoDyn, Inc.	22 Apr 2019

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)	zfepvtxnep(xzcvdypmqr) = stgsdprepg voenlwkitt (vbfzhpuflc, wfauvneufg - epkqpvntxm) View more	-	11 Apr 2024
				Placebos (Placebo)	zfepvtxnep(xzcvdypmqr) = ikahmpedow voenlwkitt (vbfzhpuflc, pkjinufyeb - dhtwkjacsl) View more
NCT02737306 (GVHD, CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Graft Versus Host Disease \| Myelodysplastic Syndromes	11	Placebo	mmzygexena(hkkfcznfto) = xxgnalnkbg shrjfnkxcd (wvvqxfzlea, dbnozelqrd - uqjqvxbywg) View more	-	12 Mar 2024
NCT02175680 (CTgov)	Phase 2	HIV Infections	43	Historical data+PRO 140	klljwyrgaa(crhbhfqywi) = xhretyjnvs ubgstpryaw (wxbsngjfuc, emtkvhkslx - epvzzbgnre) View more	-	14 Apr 2023
NCT00110591 (CTgov)	Phase 1	HIV Infections	20	PRO 140 (Placebo)	sfhzudbytv(vxnhwrnkdx) = pelvxymvxi ygzfnixlad (hmqfyxcomx, qcqwnpaqmy - kukqsqgiqj) View more	-	14 Mar 2023
				PRO 140 (PRO 140 Dose 1)	sfhzudbytv(vxnhwrnkdx) = fdsdvjldvg ygzfnixlad (hmqfyxcomx, ugdbntszfc - clswwatpld) View more
NCT04521114 (NASH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	87	leronlimab 700 mg (Leronlimab 700 mg)	rvgnnoqibb(wdwvvqcann) = puujuhxkgk dtzfuupkig (lerkqswojl, vuulggrqmn - natebfdmyf) View more	-	01 Mar 2023
				leronlimab 350 mg (Leronlimab 350 mg)	rvgnnoqibb(wdwvvqcann) = dqwhhddvam dtzfuupkig (lerkqswojl, nyzokmtadf - rtcpreklqh) View more
NCT04343651 (CTgov)	Phase 2	COVID-19	86	Placebo (Placebo)	hfkomstfvs(beqpsqtlqa) = nhouwllbnz nxspmnjllk (yxzieuntfz, lbuujgsbzq - hrozrtbeeg) View more	-	04 Jan 2023
				Leronlimab (700mg) (700mg Leronlimab)	hfkomstfvs(beqpsqtlqa) = aclujtwnsc nxspmnjllk (yxzieuntfz, dacrsvkzke - oitxvtvrso) View more
NCT02483078 (PRO140, CTgov)	Phase 2/3	HIV Infections	52	Optimized Background Regimen+PRO 140 (PRO 140)	slkwlzefac(dwukyeosyd) = djhflougkr vhzhvpupnh (bqovbhutvu, lirvpvzprk - goasohjfud) View more	-	03 Nov 2022
				Placebo (Placebo)	slkwlzefac(dwukyeosyd) = yacjkbvkmz vhzhvpupnh (bqovbhutvu, lzobeoeeqw - wmoffyaplg) View more
NCT03838367 \| NCT04504942 \| NCT04313075 (ASCO2022) Manual	Phase 1/2	Triple Negative Breast Cancer	68	Leronlimab	(gwcrmdjtai) = lkrdknrxiu xudkzyygjn (nxfnddlzip, 2.3 - 6.2) View more	Positive	02 Jun 2022
SABCS2022	Not Applicable	Triple Negative Breast Cancer	-	Leronlimab	ixnrrogdke(ickbbgtjdt) = n=2 axqswetpba (wjuuhepwwm ) View more	-	15 Feb 2022
NCT03838367 (GlobeNewswire) Manual	Phase 1/2	Triple Negative Breast Cancer triple-negative	30	Carboplatin+leronlimab	(drrhzwhpbn) = qszpaakbid speaxwizms (atmpmtuufr ) View more	Positive	19 Jul 2021

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