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Associated Press
24-03-2025
- Business
- Associated Press
Tharimmune Announces Positive Results for Novel Oral Monoclonal Antibody TH023 Targeting Tumor Necrosis Factor-alpha
BRIDGEWATER, NJ / ACCESS Newswire / March 24, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ('Tharimmune' or the 'Company'), a clinical-stage biotechnology company focused on immunology and inflammation, today announced positive preclinical results for its novel oral antibody, TH023. In a murine model, a proprietary protease enzyme stabilized platform demonstrated successful delivery of infliximab, a tumor necrosis factor-alpha (TNF-α) inhibitor, in serum with concentrations detected being significantly higher than the standard serum trough concentration needed for antibody efficacy in immunology indications via injection (~3-5µg/ml). These findings represent a significant step towards developing a more convenient and potentially patient-preferred alternative to currently available infliximab treatments, which are administered via intravenous infusion or subcutaneous injection. Key findings of the preclinical evaluation include demonstrating enzymatic protection of infliximab against human colon enzymes ex vivo using fresh fecal samples from healthy subjects utilizing the Soteria® platform, a proprietary formulation of natural amino acids (data not shown). Furthermore, successful delivery of TH023 in vivo into both local colonic tissue and systemic circulation was shown following intra-duodenal once-daily dosing for 1 week in a healthy mouse model at two doses of infliximab. This data shows the potential of the delivery platform to allow for both local delivery of the antibody precisely in the large intestinal tissue through enzymatic stabilization, as well as systemic circulation, which is an ideal pharmacokinetic (PK) profile for targeting both local gastrointestinal (GI) diseases such as inflammatory bowel disease (IBD) as well as systemic inflammatory diseases. The mechanism by which the antibody transcytosis occurs in the GI tract was shown to be a combination of passive, as well as mediated via the neonatal fragment crystallizable receptor (FcRn), highly expressed in distal intestinal epithelial cells enabling active transport. Additionally, the study demonstrated that tissue penetration of infliximab in combination with the enzyme stabilization platform was superior to a traditional permeation enhancer, sodium N-(8-[2-hydroxylbenzoyl] amino) caprylate (SNAC), which has been used to enhance the absorption of GLP-1 peptides, such as semaglutide. Utilization of SNAC to protect infliximab from enzymatic degradation or permeation enhancement did not result in tissue or serum concentrations suggesting standard off-the-shelf oral peptide delivery technologies are not suitable for oral delivery of antibodies. Two other standard permeation enhancer technologies tested (sodium caprate and labrasol) also showed unsitable results for oral delivery (data not shown), further supporting the Company's proprietary TH023 formulation. The Company announced last year through a partnership with Intract Pharma, an exclusive license to INT-023 (now TH023), an oral anti-TNF-α monoclonal antibody. Tharimmune licensed global development and commercialization rights (outside of South Korea) to Intract Pharma's Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Traditionally administered through intravenous infusions, oral delivery of antibodies is challenging due to the complexity of navigating such large molecules through the GI tract. An oral route of administration holds potential to improve patient compliance and quality of life, while also reducing the burden on the healthcare system associated with long-term intravenous therapy. 'We are extremely encouraged by these results, which validate the potential of our partnership with Intract and the platform to deliver complex biologic molecules like infliximab orally,' said Randy Milby, CEO of Tharimmune. 'This represents a potential major milestone in our mission to develop more patient-friendly and accessible treatment options for chronic inflammatory diseases, addressing a multi-billion dollar market. These findings provide a strong foundation for further development into clinical trials.' Through the Company's existing partnership with Intract the data announced today enables for the targeted delivery of antibody therapeutics directly to the colon or small intestine. By leveraging Intract's platform, Tharimmune aims to enhance the effectiveness of TNF-α inhibitors such as infliximab through precision delivery that maximizes proteolytic stabilization and tissue permeation. This novel approach offers significant potential for directly addressing inflammatory conditions within the GI tract, including IBD as well as systemic inflammatory disorders where TNF-α plays a critical role in disease progression. Tharimmune plans to optimize the formulation and dosing regimen and prepare to conduct a first-in-human clinical trial with TH023 in the next 12 months. Infliximab, a TNF-α inhibitor, is a widely used biologic for the treatment of several chronic inflammatory diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Globally, infliximab (including biosimilars) generated approximately $6.3 billion in sales in 2022, demonstrating the significant market for this therapy. However, current administration routes require frequent visits to healthcare facilities, which can be burdensome for patients and contribute to significant healthcare costs. Experts suggest the market for infliximab could rise to $9 billion within 10 years. An oral formulation of infliximab has the potential to improve patient convenience and compliance and eliminating the need for injections or infusions which could significantly improve the patient experience and potentially lead to better treatment adherence. Oral administration could reduce the need for clinic visits and specialized nursing care, potentially lowering overall treatment costs. A more convenient oral option could make infliximab accessible to a broader patient population, particularly in areas with limited access to infusion centers. By offering a differentiated, patient-preferred oral option, Tharimmune aims to capture a portion of the existing and growing infliximab market which represents a substantial commercial opportunity. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multispecific biologics targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. For more information, please visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'depends,' 'estimate,' 'expect,' 'intend,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'should,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts: Tharimmune, Inc. Tirth T. Patel 212-201-6614 SOURCE: Tharimmune Inc.
Yahoo
12-03-2025
- Business
- Yahoo
French publishers and authors file lawsuit against Meta in AI case
PARIS (Reuters) - France's leading publishing and authors' associations have filed a lawsuit against U.S. tech giant Meta for allegedly using copyright-protected content on a massive scale without authorisation to train its artificial intelligence (AI) systems. Representatives for Meta did not immediately respond to a request for comment. The National Publishing Union (SNE), the leading professional publishing association, the National Union of Authors and Composers (SNAC) and the Society of Men of Letters (SGDL), which defend the interests of authors, told a press conference on Wednesday they had filed a complaint against Meta earlier this week in a Paris court for alleged copyright infringement and economic "parasitism". The three associations believe that Meta, which owns the Facebook, Instagram and WhatsApp social networks, was illegally using copyrighted content to train its AI models. "We are witnessing monumental looting," said Maia Bensimon, general delegate of SNAC. "It's a bit of a David versus Goliath battle," SNE Director General Renaud Lefebvre said. "It's a procedure that serves as an example," he added. This is the first such action against an AI giant in France but there is a wave of lawsuits notably in the United States against Meta and other tech companies by authors, visual artists, music publishers and other copyright owners over the data used to train their generative AI systems. In the United States, Meta is notably the target of a lawsuit filed in 2023 by American actress and author Sarah Silverman and other authors. The plaintiffs argue that Meta misused their books to train its large language model Llama. American novelist Christopher Farnsworth filed a similar lawsuit against Meta in October 2024. OpenAI, the company behind the AI tool ChatGPT, also faces a series of similar lawsuits in the United States, Canada, and India.
Reuters
12-03-2025
- Business
- Reuters
French publishers and authors file lawsuit against Meta in AI case
PARIS, March 12 (Reuters) - France's leading publishing and authors' associations have filed a lawsuit against U.S. tech giant Meta (META.O), opens new tab for allegedly using copyright-protected content on a massive scale without authorisation to train its artificial intelligence (AI) systems. Representatives for Meta did not immediately respond to a request for comment. The National Publishing Union (SNE), the leading professional publishing association, the National Union of Authors and Composers (SNAC) and the Society of Men of Letters (SGDL), which defend the interests of authors, told a press conference on Wednesday they had filed a complaint against Meta earlier this week in a Paris court for alleged copyright infringement and economic "parasitism". The three associations believe that Meta, which owns the Facebook, Instagram and WhatsApp social networks, was illegally using copyrighted content to train its AI models. "We are witnessing monumental looting," said Maia Bensimon, general delegate of SNAC. "It's a bit of a David versus Goliath battle," SNE Director General Renaud Lefebvre said. "It's a procedure that serves as an example," he added. This is the first such action against an AI giant in France but there is a wave of lawsuits notably in the United States against Meta and other tech companies by authors, visual artists, music publishers and other copyright owners over the data used to train their generative AI systems. In the United States, Meta is notably the target of a lawsuit filed in 2023 by American actress and author Sarah Silverman and other authors. The plaintiffs argue that Meta misused their books to train its large language model Llama. American novelist Christopher Farnsworth filed a similar lawsuit against Meta in October 2024. OpenAI, the company behind the AI tool ChatGPT, also faces a series of similar lawsuits in the United States, Canada, and India.
Yahoo
07-02-2025
- Business
- Yahoo
America's Super Bowl obsessions: Chicken wings, chips, snack foods
Even before the Kansas City Chiefs or the Philadelphia Eagles hit the field for Sunday's Super Bowl in New Orleans, fans already know who the winners are. Come game time, chicken wings and snack foods reign mighty and are the real champs. Fans or party guests may not remember who scored a touchdown or made a game-winning interception, but they'll remember buying and snacking on loads of chicken wings and bowlfuls of snack foods. Overall, with more than 203 million adults planning on watching the game, according to the National Retail Federation, spending is predicted to be nearly $19 billion with watching spending $92 on average. Food and drink accounts for the largest share (81%) of that spending, ahead of team apparel, decorations, and other items. Sales of savory snack food sales in the week leading up to Super Bowl 2024 clocked in at $670 million, according to data commissioned by the SNAC International (SNAC), the snack industry's trade association. 'The week leading up to the Super Bowl is the most significant benchmark for the snack food industry,' stated Christine Cochran, President and CEO of SNAC in a news release. 'The brands that stand out during this pivotal week are positioning themselves for big things in the year ahead.' Ahead of Super Bowl 2024, SNAC's data revealed Americans bought: 107 million pounds of savory snacks or the equivalent of the weight of more than 15 million Vince Lombardi trophies. Each trophy, according to SNAC, weighs in at about 7 pounds. Tortilla/tostada chips and corn snacks are the two products that saw significant sales spikes. SNAC's data revealed that dollar values spiked by double percent increase in these specific snack food categories: Tortilla/tostada chips sold: 34 million pounds valued at $172.2 million, a 31.7% increase Potato chips sold: 28.9 million pounds, valued at $180.6 million, a 12.5% increase Cheese snacks sold: 7.8 million pounds and valued at $58.6 million, an 11% increase Corn snacks sold: 6.2 million pounds with a $43.2 million, a 14.4% increase Pretzels sold: 9.6 million pounds for $42.6 million, an 8.2% increase When the Super Bowl rolls around, "nothing is hotter than chicken wings," the National Chicken Council (NCC) says. The council's annual Chicken Wing Report, projects Americans will consume 1.47 billion chicken wings while watching the Kansas City Chiefs and Philadelphia Eagles battle on Sunday. That figure is a more than 1% increase from 2023 or about 20 million more chicken wings. 'Matthew McConaughey was right: Football is for food,' NCC spokesperson Tom Super said in a new release. 'Sure, there will be pizza, guacamole, chips, and dips, but when it comes to the Super Bowl, chicken wings rule the roost. ' In truth, 1.47 billion chicken wings is a lot wings. Here's how that amount of wings stacks up according to the NCC: If every single player in the NFL ate 50 wings a day (and was immortal) it would take them, collectively, 720 years to eat 1.47 billion. 1.47 billion wings laid end to end would stretch to and from GEHA Field at Arrowhead Stadium in Kansas City, Missouri to Lincoln Financial Field in Philadelphia, Pennsylvania about 63 times. Enough to give more than four wings each to every man, woman, and child in the United States. Laid end-to-end, 1.47 billion wings would circle the Earth more than 3 times. Contact Detroit Free Press food and restaurant writer Susan Selasky and send food and restaurant news and tips to: sselasky@ Follow @SusanMariecooks on Twitter. Subscribe to the Free Press. This article originally appeared on Detroit Free Press: America's Super Bowl obsessions: Chicken wings, chips, snack foods
