Cue Biopharma receives Pre-IND feedback from FDA for CUE-401
Cue Biopharma (CUE) announced it has received Pre-Investigational New Drug, or Pre-IND, feedback from the FDA. The FDA reviewed the first-in-human trial design, including the Company's plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company's lead autoimmune asset, a first-in-class bispecific fusion protein/molecule designed to induce and expand regulatory T cells in vivo through the co-activity of transforming growth factor beta and a modified variant of interleukin.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Global Juice Testing Industry on Track for Robust 8.2% CAGR Growth
Delray Beach, FL, June 25, 2025 (GLOBE NEWSWIRE) -- The juice testing market size is on an upward trajectory, expected to rise from USD 0.86 billion in 2025 to USD 1.28 billion by 2030, at a CAGR of 8.2%. This growth is fueled by rising health awareness, strict regulatory standards, and increasing demand for safe, high-quality beverages across the globe. Why Juice Testing Is Becoming a Non-Negotiable Consumers today are more conscious than ever about what they drink. The surge in contamination incidents, food fraud, and allergen-related recalls has made safety testing a top priority for juice manufacturers. Combined with expanding global juice production and stricter international trade rules, the need for reliable testing protocols has never been greater. Public Health Concerns Are Reshaping the Industry Since the 1990s, juice-related outbreaks involving E. coli, Salmonella, and Cryptosporidium have sparked serious public health alarms. These issues led to the rollout of HACCP-based safety regulations by the U.S. FDA, which set the standard for the global juice testing landscape. The continued push for safer beverages is driving rapid advancements in testing technologies and lab services. Europe Emerges as the Powerhouse of Juice Testing European juice testing industry is poised to lead the market over the next five years, thanks to its tough regulatory framework and high consumer expectations. Countries like Germany, France, the UK, and Italy boast world-class laboratories that support extensive chemical, microbial, and allergen testing. The region's focus on organic and clean-label juices also strengthens its leadership position in the global market. Chemical Testing: The Backbone of Quality Assurance Chemical testing holds a commanding share in the juice testing sector. From acidity levels and preservatives to trace contaminants, chemical analysis ensures every product meets safety and labeling standards. With advancements in chromatography and spectrometry, manufacturers are better equipped to deliver safe, compliant, and high-quality juices. Request a call with our Analysts to tailor solutions for your business Mixed Juices Create a Demand for Deeper Testing Mixed juices—popular for their nutritional diversity and innovative flavors—are driving the need for more comprehensive testing. These blends often contain multiple fruits and vegetables, making testing crucial to ensure consistency, accurate labeling, and safety. As consumers seek functional beverages and clean-label options, manufacturers are ramping up quality control to stay competitive. Latest Moves Shaping the Juice Testing Landscape Intertek launched a new regional headquarters in Riyadh (Feb 2025), improving access to localized compliance and testing. Mérieux NutriSciences expanded its global lab footprint by acquiring Bureau Veritas' food testing operations (Feb 2025). SGS opened a new facility in New Jersey (Oct 2024), boosting its juice testing capabilities in North America. ALS introduced InviRapid allergen detection strips (Aug 2024), enabling faster on-site safety checks. Who's Leading the Market? The juice testing industry is supported by a robust ecosystem of global players, including: Eurofins Scientific SGS Société Générale de Surveillance SA ALS Intertek Group plc Mérieux NutriSciences Certified Group TÜV SÜD Symbio Labs Alfa Chemistry FoodChain ID AGQ Labs Tentamus The Road Ahead: Safe, Transparent, and Trusted Juices With consumer demand for transparency and health-focused beverages rising, the role of juice testing is only becoming more critical. Whether it's through advanced technology, quicker turnaround times, or stricter compliance requirements, the industry is evolving rapidly. As safety becomes a selling point, thorough testing is set to become a core pillar of every juice brand's strategy. Scale Your Reach in a Growing Market—Connect with Leading Juice Testing Manufacturers CONTACT: About MarketsandMarkets™ MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. To find out more, visit or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Rohan Salgarkar MarketsandMarkets™ INC. 1615 South Congress Ave. Suite 103, Delray Beach, FL 33445, USA: +1-888-600-6441 Email: sales@ Visit Our Website: in to access your portfolio
Associated Press
4 hours ago
- Associated Press
Liminatus Pharma Charts Dual-Front Attack on Cancer with IBA101
La Palma, CA June 24, 2025 --( )-- Next-generation CD47 inhibitor advances toward human trials in U.S. and Korea, with the prospect of safer, more potent immunotherapy. Since its Nasdaq debut earlier this year, Liminatus Pharma has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates. By sparing red blood cells and platelets through targeted epitope selection and Fc engineering, IBA101 enables higher dosing levels—potentially unlocking more robust anti‑tumor responses without compromising patient safety. Behind the scenes, the company is preparing its IND-enabling package after completing pivotal GLP toxicology and pharmacology studies in non‑human primates at Charles River Laboratories, as well as downstream process development for clinical‑grade production. These data indicated that IBA101 did not induce clinically meaningful reductions in hemoglobin or platelet counts, clearing the path for simultaneous submissions to the U.S. Food and Drug Administration (FDA) and Korea's Ministry of Food and Drug Safety (MFDS) in the second half of 2026. Liminatus anticipates site activations and patient screening to begin in early 2027. Building on a Dual-Axis Mechanism IBA101 leverages a two-pronged approach: it blocks CD47—the 'don't‑eat‑me' signal—on tumor cells to reactivate macrophage‑mediated clearance, and it remodels the tumor microenvironment by enhancing macrophage turnover and antigen presentation. This innate immune activation primes T cells to exert more potent cytotoxicity. In preclinical combination studies, pairing IBA101 with PD‑1/PD‑L1 inhibitors resulted in significant increases in complete response rates versus monotherapy, bolstering expectations for superior clinical efficacy. A Strategic Collaboration in Seoul Liminatus has partnered with Dr. Se-Hoon Lee, a leading lung cancer specialist at Samsung Medical Center in Seoul, South Korea. This partnership secures access to advanced non‑small‑cell lung cancer patients and state‑of‑the‑art translational laboratories. Serial tumor biopsies, immune‑cell phenotyping, and multimodal omics analyses will be integrated into the Phase 1 protocol, which features a 3 + 3 dose‑escalation design followed by expansion cohorts and adaptive combination arms with approved PD‑1/PD‑L1 agents. The trial will focus on elucidating the specific conditions under which the combination of IBA101 and PD‑1/PD‑L1 blockade delivers superior anti‑tumor efficacy, and Dr. Sehoon Lee is the ideal partner to lead this purpose‑driven research. Lessons from Early CD47 Efforts Interest in CD47 blockade has been intense but challenging. Gilead acquired Forty Seven Inc., the primary asset for which was a CD47 blockade [technology][patent] and Pfizer signed a licensing deal for a CD47 blockade [patent], but both programs were paused due to severe anemia and thrombocytopenia caused by off‑target binding to red blood cells and platelets. By contrast, IBA101 selectively binds CD47 epitopes on tumor and immune cells: additional glycosylation on RBC and platelet CD47 proteins prevents IBA101 engagement, minimizing off‑target interactions and reducing the risk of cytopenias. Preclinical primate data suggest this design will translate into a markedly improved safety profile in humans. Top row: intact RBC pellets with clear supernatant after IBA101 treatment (no hemolysis). Bottom row: diffuse red supernatant in control wells (RBC lysis). Beyond Cancer: Toward Chronic Inflammation While oncology is the primary focus, Liminatus is also exploring IBA101's potential in chronic inflammatory diseases. Early mechanistic studies in humanized mouse models are underway to evaluate whether macrophage activation can clear senescent cells and pro‑inflammatory debris—hallmarks of age‑related conditions such as atherosclerosis and neurodegeneration. Although these investigations remain exploratory, they establish a foundation for future indication expansion. Economic Upside and Market Context Global PD‑1/PD‑L1 sales exceeded $30 billion in 2024, but looming patent expirations will invite biosimilar competition. Combining CD47 blockade technology with PD‑1/PD‑L1 therapies offers two key advantages: enhanced response rates in combination regimens and a fresh patent lifecycle to extend commercial value. Liminatus projects that a successful IBA101 launch could secure a significant share of the post‑patent market. Looking Ahead With a Nasdaq listing, a robust nonclinical data package, and strategic clinical partnerships in Korea and the United States, Liminatus Pharma is poised to enter the clinic in 2027. With safety and synergy at its core, IBA101 aims to fulfill the long‑awaited promise of CD47 blockade and usher in a new era of combination immunotherapy. About IBA101 IBA101 is a second‑generation CD47 blockade antibody licensed from InnobationBio (Seoul, South Korea). IBA101 minimizes erythrocyte and platelet binding, thereby avoiding the severe cytopenias that plagued first‑generation agents. By enhancing macrophage activation and antigen presentation, IBA101 complements adaptive checkpoint inhibitors such as PD‑1/PD‑L1 antibodies and may offer broader applications in chronic inflammatory diseases. About Liminatus Pharma Liminatus Pharma (Nasdaq: LIMN) is a preclinical‑stage immuno‑oncology company advancing IBA101 toward best‑in‑human trials. Building on over a decade of CD47 research and lessons learned from industry setbacks, Liminatus's mission is to develop next‑generation immunotherapies that restore immune balance—bridging innate and adaptive immunity to drive safer, more durable anti‑tumor responses. Forward-Looking Statements Certain statements in this press release constitute forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding management's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The following factors, among others, could cause actual results and future events to differ materially from those set forth or contemplated in the forward-looking statements: · the success of clinical trials · the ability of Liminatus to raise financing in the future; · the attraction and retention of qualified directors, officers, employees and key personnel of Liminatus; · the ability of Liminatus to execute its business plans and strategy; · the ability of Liminatus to compete effectively in a highly competitive market; · the competition from larger pharmaceutical and biotechnology companies that have greater resources, · The success of competing therapies and products that are or may become available; · the costs, timing, and results of Liminatus's preclinical studies and clinical trials, as well as the number of required trials for regulatory approval and the criteria for success in such trials; · legal and regulatory developments in the United States, or U.S., and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress, or outcome of clinical trials or result in the need for additional clinical trials; · cost of complying with current laws and regulations, and any changes in applicable laws or regulations; · The ability to protect and enhance Liminatus's corporate reputation and brand. · The impact of future regulatory, judicial, and legislative changes in Liminatus's industry; · The ability of Liminatus to obtain and maintain regulatory approval of any of its product candidates; · The ability of Liminatus to research, discover, and develop additional product candidates; · risks related to manufacturing active pharmaceutical ingredients, drug products, and other materials we need; · the performance of third parties upon which Liminatus depends, including contract research organizations, contract manufacturing organizations, contract laboratories, and independent contractors; · The ability of Liminatus to grow and manage growth profitably. · The ability of Liminatus to obtain and maintain intellectual property protection and not infringe on the rights of others. · The ability of Liminatus to limit its exposure under product liability lawsuits; · The inability to develop and maintain effective internal controls; · The impact of pandemics and other similar disruptions in the future. · those factors set forth in documents of Liminatus filed, or to be filed, with the SEC; and · Other factors that Liminatus may not have identified or quantified. The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects. Future developments affecting Liminatus may not be those that Liminatus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of Liminatus), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Liminatus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. In addition, statements that 'we believe' and similar statements reflect beliefs and opinions on the relevant subject. These statements are based upon information available to Liminatus as of the date of this press release, and while Liminatus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and such statements should not be read to indicate that Liminatus has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements as predictions of future results. Liminatus's actual future results may be materially different from what it expects. Liminatus qualifies all forward-looking statements by these cautionary statements. For more information, please contact: Chris Kim, Chief Executive Officer [email protected] Contact Liminatus Pharma, Inc Chris Kim 213-273-5453 Contact Information: Liminatus Pharma, Inc Chris Kim 213-273-5453 Contact via Email Read the full story here: Liminatus Pharma Charts Dual-Front Attack on Cancer with IBA101 Press Release Distributed by
Associated Press
4 hours ago
- Associated Press
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. Alyssa Johnsen Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi 'Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients.' Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients ( NCT05156710 ). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: NCT06290128 ), and in IVIg-treated patients (VITALIZE, clinical study identifier: NCT06290141 ). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs. About Riliprubart SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit About AMR Antibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Léo Le Bourhis | +33 6 75 06 43 81 | [email protected] Victor Rouault | +33 6 70 93 71 40 | [email protected] Timothy Gilbert | +1 516 521 2929 | [email protected] Léa Ubaldi | +33 6 30 19 66 46 | [email protected] Investor Relations Thomas Kudsk Larsen | +44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | +1 617 710 3587 | [email protected] Thibaud Châtelet | +33 6 80 80 89 90 | [email protected] Yun Li | +33 6 84 00 90 72 | [email protected] Sanofi forward-looking statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment
