Latest news with #CCR5
Yahoo
30-05-2025
- Business
- Yahoo
Clinical Trials Demonstrate Monitoring PD-L1 Upregulation Using LifeTracDx Blood Test Could Support New Treatment Path for Metastatic Triple Negative Breast Cancer
MONMOUTH JUNCTION, N.J., May 30, 2025 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv") in collaboration with CytoDyn Inc. ("CytoDyn") presents promising four-year survival rates from a pooled clinical trial analysis of patients with metastatic triple-negative breast cancer ("mTNBC") treated with leronlimab and PD-L1 immune checkpoint inhibitors ("ICI"). Leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, was tested with and without ICIs in n=28 mTNBC patients. Results indicated that leronlimab treatment correlated with increased expression of PD-L1 on circulating tumor associated cells, as measured using the LifeTracDx® blood test from Creatv. The analysis also revealed promising survival observations among patients who experienced a significant increase in PD-L1 expression and subsequently pursued treatment with an ICI. Four year follow-up results were presented at the ESMO Breast Cancer meeting on May 15, 2025 by Dr. Richard Pestell, available here. The LifeTracDx® is a universal cancer blood test that uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response in cancer patients. In the trials presented at ESMO, results showed that monitoring the expressions of PD-L1 before and after induction of leronlimab using the LifeTracDx® blood test identified upregulation of PD-L1 expression in 76% of patients after therapy induction. In a 4-year overall survival follow-up, 5 of the patients with upregulated PD-L1 detected by LifeTracDx® blood test and treated with the ICIs atezolizumab or pembrolizumab were alive after four years. About Creatv Bio Creatv Bio is a cancer screening and cancer diagnostics company providing testing services to patients and to 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 an array of clinical applications including predicting response to a new therapy in 30 days, providing companion/complementary diagnostics such as PD-L1 using blood samples, 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. Creatv contacts:Daniel Adams,Ron Baker Chief Scientific OfficerChief Business Officer dan@ 732-783-7132 (office)301-785-5185 (mobile) View original content to download multimedia: SOURCE Creatv MicroTech, Inc. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Business Upturn
13-05-2025
- Business
- Business Upturn
CytoDyn Announces Data Suggesting Novel Mechanism of Action of Leronlimab for the Treatment of Solid Tumors
Survival observations in mTNBC patients correlated with increased PD-L1 expression Preliminary evidence suggests leronlimab has potential to turn 'cold' tumors 'hot' VANCOUVER, Washington, May 13, 2025 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTCQB: CYDY) ('CytoDyn' or the 'Company'), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced new data suggesting a novel mechanism of action of leronlimab for the treatment of solid tumors. CytoDyn analyzed data from its prior clinical trials of patients with metastatic Triple-Negative Breast Cancer ('mTNBC') and found that leronlimab treatment correlated with increased expression of an immune cell protein or 'checkpoint inhibitor' known as programmed death-ligand 1 ('PD-L1') on patient's circulating tumor cells ('CTCs'). CytoDyn's results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab. Increasing expression of PD-L1 can be likened to turning 'cold' tumors 'hot', elevating PD-L1 levels to the level necessary for patients to potentially derive benefit from further treatment with a class of drugs known as immune checkpoint inhibitors ('ICIs'). As previously announced, CytoDyn identified a group of patients with mTNBC who had failed a median of two prior lines of treatment in the metastatic setting but showed improved overall survival rates after receiving leronlimab. The Company confirmed that 5/5 patients (100%) who demonstrated a significant increase in PD-L1 expression after receiving leronlimab and received treatment with any ICI remain alive today. Four of these patients (80%) currently identify as having no evidence of disease, and the fifth patient is alive and identified by the clinical site as 'stable.' If the results above are confirmed prospectively, the Company believes the mechanism could be effective across a wide range of solid tumor types, and in particular benefit cancer patients with low levels of PD-L1 who were previously unresponsive to or ineligible for checkpoint inhibitors. 'Leronlimab's induction of PD-L1 on CTCs in patients with otherwise 'cold' tumors opens a promising field of exploration for what could amount to significant improvements to patient care and outcomes in solid tumor oncology,' said Richard Pestell, MD, PhD, AO, the Company's Lead Consultant in Preclinical and Clinical Oncology. 'We are hopeful that further short-term investigation will confirm our working theory and open new pathways for patients with a range of common and aggressive forms of cancer to access treatment options that were previously out of reach.' 'We are thrilled to announce this apparent mechanism behind the improved survival in patients with refractory and metastatic TNBC,' said Dr. Jacob Lalezari, CEO of CytoDyn. 'Leronlimab's ability to induce an inflamed or 'hot' tumor environment, that could then be treated with ICIs, would be a game changer in solid tumor oncology. Prospectively confirming these findings in patients with TNBC is a top priority. We have also amended our current colorectal cancer trial to ensure the prospective collection of PD-L1 data in a second type of solid tumor.' 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, clinical trial results, 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, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media Contacts CytoDyn Inc. Riyaz Lalani Gagnier Communications [email protected]
Yahoo
13-05-2025
- Health
- Yahoo
Viking DNA helps reveal when HIV-fighting gene mutation emerged: 9,000 years ago near the Black Sea
When you buy through links on our articles, Future and its syndication partners may earn a commission. A gene variant that helps protect people from HIV infection likely originated in people who lived during the span of time between the Stone Age and the Viking Age, a new study of thousands of genomes reveals. "It turns out that the variant arose in one individual who lived in an area near the Black Sea between 6,700 and 9,000 years ago," Simon Rasmussen, a bioinformatics expert at the University of Copenhagen and co-senior author of the study, said in a statement. The variant must have been helpful for something else in the past, since HIV in humans is less than a century old. In a study published May 5 in the journal Cell, Rasmussen and his colleagues detailed their search for the origin of a genetic mutation known as CCR5 delta 32. CCR5 is a protein predominantly found in immune cells that many — but not all — HIV strains use to break into those cells and trigger infection. But in people with two copies of the CCR5 delta 32 mutation, the protein gets disabled, essentially "locking out" the HIV virus. Scientists have taken advantage of this mutation to cure a handful of people of HIV. Related: Mysterious case of the 'Geneva patient,' the latest person in long-term remission from HIV, raises questions Scientists have learned that this variant makes up 10% to 16% of CCR5 genes seen in European populations. However, attempts to identify its origin and trace its spread have previously come up short, since ancient genomes are often extremely fragmentary. In the new study, the research team identified the mutation in 2,504 genomes from modern humans sampled for the 1000 Genomes Project, an international effort to catalog human genetic variation. Then, they created a model to search 934 ancient genomes from various regions of Eurasia ranging from the early Mesolithic period to the Viking Age, from roughly 8000 B.C. to A.D. 1000. "By looking at this large dataset, we can determine where and when the mutation arose," study co-author Kirstine Ravn, a researcher at the University of Copenhagen, said in the statement. The team's genetic detective work revealed that the person who first carried this mutation lived near the Black Sea around 7000 B.C., around the time early farmers arrived in Europe via Western Asia. The researchers also discovered that the prevalence of the mutation exploded between 8,000 and 2,000 years ago, suggesting it was extremely useful as people moved out of the Eurasian steppe. The study's findings contradict previous assumptions that the mutation emerged more recently. For instance, this means that the increase in the frequency of the mutation did not result from medieval plagues or from Viking exploration, which may have introduced pressure for humans' immune cells to evolve. When it's not being ransacked by HIV, the CCR5 protein helps control how immune cells respond to signals called chemokines, likely helping direct cells to sites of inflammation in the body. RELATED STORIES —1,500 ancient European genomes reveal previously hidden waves of migration, study finds —Ancient hunter-gatherer DNA linked to higher BMI in modern Japanese people —Ancient DNA and modern genomes can reveal stories of past peoples, from the Iron Age to Chernobyl, geneticist says The researchers suggest that people who carried the special CCR5 variant had an advantage. "People with this mutation were better at surviving, likely because it dampened the immune system during a time when humans were exposed to new pathogens," study co-author Leonardo Cobuccio, a postdoctoral researcher at the University of Copenhagen, said in the statement. While this sounds negative, an overly aggressive immune system can be deadly, he said — when facing new germs, you want just enough of an immune response to subdue the threat without hurting the body itself. "As humans transitioned from hunger-gatherers to living closely together in agricultural societies," Cobuccio said, "the pressure from infectious diseases increased, and a more balanced immune system may have been advantageous." Of course, this is a hypothesis; the exact pressures that lead to the variant's increase aren't known for sure.
Yahoo
27-03-2025
- Health
- Yahoo
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:Daniel Adams,Ron Baker Chief Scientific OfficerChief Business Officerdan@ (office)301-785-5185 (mobile) View original content to download multimedia: SOURCE Creatv MicroTech, Inc. Sign in to access your portfolio
Yahoo
06-02-2025
- Business
- Yahoo
CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
VANCOUVER, Washington, Feb. 06, 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, announced today positive results from its preclinical studies with SMC Laboratories ('SMC'). The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35. 'The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab's ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,' said Melissa Palmer, MD FAASLD, the Company's Lead Consultant in Hepatology. Dr. Jacob Lalezari, CEO of CytoDyn, added, 'We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab's core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions. As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart.' CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings. The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs. 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 infectious disease, oncology, and autoimmune conditions. 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 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 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 CytoDyn Inc. Riyaz Lalani Gagnier Communications CytoDyn@ in to access your portfolio
