galectin-3

BOSTON, MASSACHUSETTS, January 10, 2025 -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat viral diseases, fibrosis, stroke, dementia, and Alzheimer's disease, announced its preprint article titled “Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients” (the “Article”) authored by Dr. Adesuyi Ajayi, Dr. David Platt, and Andrew Blumenthal. The preprint reviews detailed theories regarding the resistance to ICI therapy and how galectin-3 contributes to resistance. Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients http://dx.doi.org/10.13140/RG.2.2.31077.31202 The Article discusses the potential of immune checkpoint inhibitors (ICIs) in cancer treatment and explores how galectin-3 modulation might enhance ICI effectiveness. It highlights the importance of overcoming resistance to ICIs and improving patient outcomes by targeting galectin-3, which could increase the objective response rate (ORR) and remission-free survival in oncology patients. Galectin-3 is also a powerful predictive biomarker of ICI failure in Non-Small Cell Lung Cancer (NSCLC) where 90% of patients with high galectin-3 levels failed to see their cancer shrink after 3 treatments. The Article also determined that low to moderate galectin-3 expression in the tumor correlated strongly with a positive response to ICI therapy. ICI resistance due to galectin-3 in the tumor microenvironment is also due to the galectin-3 glycoprotein occupying the antibody’s PD-1 receptor binding site. This was confirmed by Surface Plasmon Resonance (a technique used to study the interactions between molecules by detecting changes in the refractive index near a sensor surface) - and cyrogenic electron microscopy. The galectin-3 protein binds in such a way that it prevents ICI’s from binding to PD-1. This leaves the receptor open to PD-L1 binding which switches off the T-Cells. In vitro tests show that galectin-3 antagonists could reverse this effect. The Company also published its cancer metastasis presentation titled “Galectin Antagonists in Cancer.” The presentation goes over the various ways that cancer tricks the immune system and the current modalities being used to fight cancer. The “Galectin Effect” was highlighted as cancers primary defense mechanism to downregulate and cloak the cancer from immune response. Shortcomings in current treatments are addressed as well as innovative approaches to address the deficiencies. The heart of the presentation shows that galectins play a key role in the tumor microenvironment, promoting tumor growth, metastasis, and immune suppression. Galectin antagonists may hold the key to overcoming these effects and improve efficacy of other cancer treatments. Galectin Antagonists in Cancer https://tinyurl.com/bdcth9j2 "The magnitude of this breakthrough in cancer research cannot be overstated," said Dr. David Platt, CEO of Bioxytran Inc. "Our findings herald a significant shift in cancer treatment paradigms. We've developed a robust theory of cancer and metastasis, identifying Galectin-3 as a pivotal driver of disease progression. This finding elucidates the variable responses in immunotherapy and the development of resistance in other cancer treatments. With over 4,000 peer-reviewed articles examining the role of galectins in cancer, one consensus is clear: they must be inhibited. Our team has synthesized this extensive body of research into the core insights presented in our preprint and cancer presentation. The data unequivocally supports the finding that combining galectin-3 antagonists can significantly enhance treatment response rates." About Bioxytran, Inc. Bioxytran, Inc. is a clinical stage biotechnology company pioneering a library of novel complex carbohydrate structures using artificial intelligence software that interprets the Nuclear Magnetic Resonance imaging of druggable targets like the galectin fold to create a rational drug design. The leading drug candidates vetted by in vitro testing, are capable of neutralizing viruses. The peer-reviewed discovery of the galectin fold located on the spike proteins of viruses such as COVID-19, RSV, and H1N1 demonstrate there exists a conserved region on the spike in which Bioxytran’s molecules achieve virus neutralization. The extent of the carbohydrate structure’s ability to neutralize untested viruses is unknown just like the initial discovery of antibiotics last century and its ability to treat a broad spectrum of bacterial infections. Applications of this platform technology extend to the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com Investor Relations Michael Sheikh 509-991-0245 mike.sheikh@bioxytraninc.com Forward-Looking Statements This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws. ‍

iStock/ Naypong Galectin’s shares tanked in premarket trading Friday after the biotech revealed its lead asset missed the primary endpoint for its Phase IIb/III trial for patients with a type of liver cirrhosis. Galectin Therapeutics’ stock is down over 35% in premarket trading Friday morning after its lead asset failed to reach its primary endpoint for patients with a form of liver cirrhosis. The Georgia-based biotech designed its Phase IIb/III trial for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and high blood pressure in the portal vein. The NAVIGATE trial’s primary endpoint was the prevention of varices—enlarged veins in the esophagus that may occur in people with cirrhosis of the liver. Belapectin in both 2 mg/kg and 4 mg/kg doses did reduce the incidence of varices in the intent-to-treat population, but the difference over placebo was not statistically significant. Galectin touted the per-protocol population—those who completed 18 months of therapy with upper endoscopy at start and finish—in which the incidence of varices was reduced by 48.9%, still short of the targeted 52.5% reduction. The safety pro the drug remains “highly encouraging,” according to the company, with adverse events and discontinuation rates across both dosage groups comparable to placebo. As a sugar-like structure, the drug has low toxicity potential because it is metabolized to relatively harmless compounds, according to the company. Belapectin blocks the action of galectin-3, a protein that plays a role in inflammation, cell growth and fibrosis. In a Phase I study , belapectin combined with Keytruda showed a 50% response rate in advanced melanoma. Naga Chalasani, a professor at Indiana University School of Medicine who has been involved in the development of belapectin, said in a statement that the drug “clearly is offering a reproducible benefit and should be continued in clinical development.” Investors are less convinced as they sent the share price tumbling sharply from its starting point of $2 on Friday morning before the markets opened. Galectin is continuing to analyze the trial data and waiting on 36-month outcomes, which should be available in early 2025. Once that’s in hand, the company will determine next steps.

Nov. 18, 2024 -- TrueBinding, Inc., a clinical-stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases and other serious diseases, has cleared an FDA Investigational New Drug (IND) application for the Biologic IgG4 antibody neutralizing Galectin-3, TB006, for potential disease modification of Parkinson’s Disease. “FDA IND approval for TB006 is a major achievement for TrueBinding and a significant potential advancement for the treatment of Parkinson’s Disease worldwide,” said Alan K. Jacobs, M.D., FAAN, Chief Medical Officer of TrueBinding. “This first-in-class therapy harnesses the power of antibody selectivity to target the protein, Galectin-3, offering a promising new option for patients with no available disease-modifying treatment options.” TB006 is a therapy that is delivered via monthly intravenous infusion and is designed to target and neutralize Galectin-3, possibly enabling the dissociation of neurotoxic oligomers including alpha-synuclein, reducing the activation of pro-inflammatory microglia and the release of associated cytokines, and providing reparative impact upon intracellular lysosomes. The approval of the IND application for the therapy will initiate the launch of Parkinson’s clinical trials in the U.S. A multi-center, placebo-controlled, Phase 2A trial (NCT) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease. The trial will enroll adults aged 50 to 80 years of age who have confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, less than five (5) years since diagnosis, and currently on no other Parkinson’s Disease medications or only immediate-release Levodopa-containing therapy. The estimated enrollment for the trial is 62 patients, and the estimated primary completion date is Q1 2026. Parkinson’s disease (PD) is a chronic and progressive neurodegenerative disorder that affects dopamine-producing cells. About 70% of people with PD experience tremor. PD symptoms often vary throughout the day, worsening with anxiety, fatigue or as medication wears off in between doses. Regular exercise can help manage PD symptoms and improve quality of life. Carbidopa/levodopa (brand name Sinemet) is still the “gold standard” in PD medications. It is common for people with PD to need adjustments to treatment as symptoms progress. Parkinson’s disease is a disorder that causes a gradual loss of cells that produce dopamine, a chemical necessary for cell-to-cell neurotransmission. As dopamine decreases over time, movement and non-motor functionality become more difficult for people with PD. Dopamine also affects mood and motivation. In addition to dopamine, Parkinson’s changes several other brain chemicals. Nearly one million people in the U.S. and 10 million people worldwide are living with PD. About 90,000 Americans are diagnosed with Parkinson’s each year. It is the second most common neurodegenerative condition after Alzheimer’s. The number of people with PD will increase substantially in the next 20 years due to our aging population. The most visible and well-known signs of PD are movement (or motor) symptoms) such as tremor, slow movement, stiffness and balance issues. However, most people also develop non-movement (or non-motor) symptoms that impact mood and quality of life. These can include anxiety, sleep issues and thinking changes. Initial symptoms can be mild and sometimes mistaken for signs of aging. Parkinson’s is a complex disease that affects everyone differently. For most people with PD, symptoms develop gradually over many years and worsen over time. Parkinson’s is typically diagnosed after 60, but people under 50 can also have PD. This is known as young-onset Parkinson’s disease (YOPD). About 4% of people with Parkinson’s have YOPD. Men are 1.5 times more likely to have Parkinson’s than women, and certain geographic areas and ethnic groups experience higher rates of PD. Researchers believe that Parkinson’s is caused by a combination of genetic, environmental and other factors. About 10 to 15% of people with PD have a genetic link. There is no single test for Parkinson’s. A doctor makes a diagnosis based on a person’s symptoms, medical history and a physical examination. Sometimes conditions that look like PD can be ruled out by additional lab tests and imaging. To consider a diagnosis of Parkinson’s disease, a person must have bradykinesia (slow movement) in addition to one or more of the following: Shaking or tremor in a limb that occurs while it is at rest Stiffness or rigidity of the arms, legs, or trunk Trouble with balance and falls A PD diagnosis can take time. When symptoms first appear, many people choose to speak to their family doctor, who may provide a referral to a neurologist if Parkinson’s is suspected. Some neurologists, called movement disorder specialists, have additional training in diagnosing and treating PD and other movement disorders. Though Parkinson’s varies from person to person, most people with PD need to take medications that boost, mimic or replace dopamine to manage their symptoms. Studies show that regular exercise also can benefit movement and non-movement symptoms and can improve overall quality of life. For some people, surgical intervention may be an option. People with PD can experience a wide range of complex symptoms, so building a team of healthcare professionals is key. This team may include physical, occupational and speech therapists as well as other specialists, including mental health professionals, a urologist or gastrointestinal doctor. TB006 is a humanized monoclonal antibody that, based on preclinical data and advancing clinical studies, has the potential to improve cognition and functioning of patients with Alzheimer’s Disease and Parkinson’s Disease. In pre-clinical evaluations, Galectin-3 was shown to intrinsically promote the aggregation of Aβ and pTau proteins. In Alzheimer’s Disease in vivo model studies, TB006, showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance, which show potential therapeutic effect of TB006 in addressing underlying pathology and ameliorating the course of Alzheimer’s Disease. In a Phase 1b/2 proof-of-concept trial in mild to severe Alzheimer’s patients, TB006, demonstrated a positive trend toward improvements in cognition and functioning. TB006 has also been evaluated in a Phase 2 open-label extension trial in patients with Alzheimer’s Disease and has been allowed by the FDA for conditional use through an Expanded Access Program. Clinical trials demonstrated that TB006 was well tolerated with a favorable safety profile. TrueBinding, Inc. is a clinical stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases including Alzheimer’s Disease and Parkinson’s Disease. The Company is focused on rapidly advancing its lead drug candidate, TB006, a humanized monoclonal antibody targeting Galectin-3. For more information, visit www.truebinding.com. 1 Reference is made to the Parkinson’s Foundation website, www.parkinsons.org The content above comes from the network. if any infringement, please contact us to modify.