Latest news with #IL-2
Yahoo
10-07-2025
- Business
- Yahoo
Teva Partners with Fosun Pharma to Advance Novel Cancer Immunotherapy TEV-56278
Teva Pharmaceutical Industries Limited (NYSE:TEVA) is one of the most promising stocks according to Wall Street analysts. On June 16, Teva Pharmaceutical announced a collaboration agreement with China-based Shanghai Fosun Pharmaceutical Group Co., Ltd. (better known as Fosun Pharma) to co-develop TEV-56278, which is an investigational anti-PD1-IL2 ATTENUKINE therapy. The partnership will accelerate clinical data generation for TEV-56278, which is currently in a Phase 1 study for various forms of cancer, such as melanoma. TEV-56278 is an internally developed Teva product and is an anti-PD-1 antibody-cytokine fusion protein that uses Teva's proprietary ATTENUKINE technology. A close-up shot of various types of medicines on a table, illustrating the specialty and generic products offered by the pharmaceutical company. Its novel mechanism of action is designed to selectively deliver interleukin-2 (IL-2) to PD-1-expressing T cells within the tumor microenvironment. Under the terms of the agreement, Fosun Pharma has been granted an exclusive license to develop, manufacture, and commercialize TEV-56278 in mainland China, the Hong Kong SAR, Macau SAR, Taiwan region, and select Southeast Asian countries. Teva Pharmaceutical Industries Limited (NYSE:TEVA) develops, manufactures, markets, and distributes generic & other medicines and biopharmaceutical products internationally. Fosun Pharma is a global healthcare company in pharmaceuticals, medical devices & diagnostics, and healthcare services. While we acknowledge the potential of TEVA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
24-06-2025
- Business
- Yahoo
Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company's Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease
CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (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 (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2). 'We are highly encouraged by the FDA's positive feedback on our proposed development plan for this important program. We believe CUE-401, with its first-in-class mechanism exploiting the combined activities of TGF-β and IL-2 is a potentially disruptive approach differentiated from other Treg-directed therapies, and has the potential to provide durable, long-lasting immune rebalance and tolerance addressing multiple, significant disease indications,' said Daniel Passeri, chief executive officer of Cue Biopharma. Dr. Dan Baker, chief development officer of Cue Biopharma commented, 'CUE-401's mechanistic design extends beyond nTreg proliferation by transforming effector/autoreactive responses to an anti-inflammatory and/or suppressive response, with the prospects of establishing tolerance. The combination of interleukin 2 (IL-2) and transforming growth factor beta (TGF-ß) is considered the 'master switch' for conversion of activated T effector cells into T cells with a regulatory phenotype.' About CUE-401CUE-401 is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the co-activity of modified variants of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases. CUE-401 has been engineered to harness the Treg induction capacity of TGF-β combined with IL-2 signaling to provide what Cue Biopharma believes to be superior quality and stability of Tregs. The design and specifications of CUE-401 have been guided by leading scientific publications demonstrating that both IL-2 and TGF-β are required for stable and efficient production of active and durable Tregs. CUE-401 is designed to overcome multiple hurdles required to exploit the therapeutic potential of a master switch with a first-in-class, bispecific molecule integrating a masked TGF-ß, with our clinically validated, attenuated IL-2 with an antibody Fc fragment. This novel design provides for 'conditional binding' and avoids off target activity, simplifies manufacturing and has highly differentiated findings in multiple pre-clinical models. In these models, CUE-401 behaves as a master switch to convert autoreactive effector T cells (inflammatory cells) into stable, induced T-regulatory cells (iTregs). These findings suggest that CUE-401 acts by establishing a 'tolerance positive feedback loop' that not only increases nonspecific Treg populations, but critically, reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific for the disease-causing autoantigens. About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. The company's proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company's expectations regarding the planned IND filing for CUE-401; the Company' expectations regarding the potential characteristics and benefit of CUE-401; the company's belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company's platform across many cancers and autoimmune diseases; and the company's business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company's future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as 'believe,' 'expect,' 'may,' 'will,' 'should,' 'would,' 'could,' 'seek,' 'intend,' 'plan,' 'goal,' 'project,' 'estimate,' 'anticipate,' 'strategy,' 'future,' 'likely' or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company's pipeline of product candidates and platforms, and its strategies, prospects, plans and objectives are forward-looking statements. Important factors that could cause the company's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the Company's ability to successfully advance is development plan for CUE-401; potential setbacks in the company's research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration ('FDA') or other governmental approvals for its product candidates, including FDA clearance of any future IND submission for CUE-401, and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company's trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company's reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company's ability to obtain adequate financing to fund its business operations in the near term; the company's ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company's most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Media ContactJonathan PappasLifeSci Communicationsjpappas@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-06-2025
- Business
- Yahoo
Engineered IL-2 Therapies Lead Innovations in Immunotherapy
The Interleukin-2 (IL-2) market is witnessing rapid growth due to advancements in cancer immunotherapy and autoimmune disease management. IL-2, a vital cytokine, promotes T-cell growth, with therapies used in treating metastatic melanoma, RCC, and evolving to target other cancers and chronic diseases. The market is driven by rising cancer cases, immunotherapy investments, and regulatory support. Despite hurdles like high costs and side effects, innovations in engineered IL-2 therapies promise effective, personalized treatments. As global healthcare access improves, the demand for IL-2 therapies rises, with pharmaceutical giants and biotech firms spearheading market transformation. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "Interleukin-2 Market - A Global and Regional Analysis: Analysis and Forecast, 2025-2035" report has been added to (IL-2) is a cytokine that plays a crucial role in the immune system by promoting the growth and differentiation of T cells, a type of white blood cell that is essential for immune responses. IL-2 has significant therapeutic applications, particularly in cancer immunotherapy and autoimmune diseases. The market for IL-2-based therapies has been evolving, driven by advancements in immuno-oncology, increased research into immune modulation, and the growing recognition of the importance of cytokine-based therapies in treating various IL-2 therapies such as Aldesleukin (Proleukin), approved by the FDA, have been used primarily for treating metastatic melanoma and renal cell carcinoma (RCC), marking significant milestones in immunotherapy. However, newer formulations and targeted IL-2 therapies are emerging, offering the potential to improve outcomes in various cancers and autoimmune global IL-2 market is growing steadily, fueled by advancements in cytokine-based treatments, expanding applications in cancer immunotherapy, and the increasing demand for immunomodulatory treatments. IL-2's role in cancer treatment and its potential in managing chronic autoimmune diseases make it a vital area of focus in modern medical research and pharmaceutical of the key drivers of the market is the rising prevalence of cancer. The global cancer burden continues to rise, with increasing rates of melanoma, renal cell carcinoma, and solid tumors. IL-2 has been shown to improve the immune response in cancers that are traditionally hard to treat with standard chemotherapy. As cancer incidence increases, there is a growing demand for innovative immunotherapies, including IL-2-based the IL-2 market is experiencing robust growth due to significant investments in immunotherapy research. Pharmaceutical companies and research institutions are pouring resources into the development of more effective and safer IL-2 therapies. This investment is driven by the increasing recognition of the effectiveness of immuno-oncology treatments in treating cancers that were previously difficult to addition, governments and regulatory bodies, such as the FDA and EMA, are offering more support for the development and approval of immunotherapies, including IL-2 treatments. The approval of new IL-2-based therapies such as NKTR-214 for use in combination with other immunotherapies has further propelled the market, as these therapies aim to provide more durable responses for cancer the promising potential of IL-2 therapies, their high cost remains a significant barrier to widespread adoption. Aldesleukin (Proleukin), for example, is expensive, and while newer engineered IL-2 treatments may offer better outcomes, they come with high price tags that limit their accessibility, particularly in developing regions or for patients without insurance global Interleukin-2 (IL-2) market is evolving rapidly, with major pharmaceutical companies and emerging biotech firms driving innovation. The market is highly fragmented, with significant ongoing research into expanding IL-2's use in treating cancer and autoimmune disorders such as lupus and multiple sclerosis. Companies are increasingly focusing on improving patients' quality of life by addressing immune-related issues alongside disease treatment, marking a transformative phase for the IL-2 Interleukin-2 (IL-2) market is undergoing significant transformation, driven by emerging trends in immunotherapy and advancements in biotechnology. One of the key trends is the increasing focus on personalized medicine, where IL-2 treatment plans are being tailored to individual patients' genetic profiles, disease progression, and immune system major trend is the growing demand for engineered IL-2 therapies that are more targeted and effective compared to traditional formulations. Engineered IL-2s such as NKTR-214 (bempegaldesleukin) are designed to enhance the selective activation of the immune system, particularly in tumor environments. These therapies have shown promising results in clinical trials, especially when combined with checkpoint inhibitors such as PD-1/PD-L1 combination therapies are gaining traction in oncology, especially for the treatment of solid tumors, where traditional therapies have shown limited success. Additionally, there is increasing interest in non-cancerous applications of IL-2, including its potential for managing autoimmune diseases such as systemic lupus erythematosus (SLE) and multiple conclusion, the Interleukin-2 (IL-2) market is poised for continued growth, driven by innovations in engineered IL-2 therapies, personalized medicine, and increased access to cutting-edge treatments worldwide. While challenges such as the high cost of biologic therapies and side effects persist, ongoing research into more targeted and safer IL-2 therapies offers hope for improved treatment outcomes. With increasing global healthcare access, the market is positioned for expansion, especially as IL-2 therapies are incorporated into combination treatments and new therapeutic areas, such as autoimmune diseases. As innovation continues, both large pharmaceutical companies and emerging biotech firms will fuel competition, ultimately improving the quality of life for patients undergoing IL-2-based Topics Covered:1. Global Interleukin-2 Market: Industry Outlook1.1 Introduction1.2 Market Trends1.3 Regulatory Framework1.4 Clinical Trial Analysis1.5 Market Dynamics2. Global Interleukin-2 Market, by Region, $Million, 2023-20352.1 North America2.2 Europe2.3 Asia Pacific3. Global Interleukin-2 Market: Competitive Landscape and Company Profiles3.1 Key Development and Strategies3.1.1 Mergers and Acquisitions3.1.2 Synergistic Activities3.1.3 Business Expansions and Funding3.1.4 Product Launches and Approvals3.1.5 Other Activities3.2 Company Profiles Bristol Myers Squibb Sanofi S.A. Corvus Pharmaceuticals Regeneron Pharmaceuticals Merck & Co., Inc. F. Hoffmann-La Roche AG Cue Biopharma For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Health
- Yahoo
‘Game-changer' new blood test to detect prevalent autoimmune disease without nightmare side effects
People with coeliac disease may soon be able to avoid consuming large quantities of gluten – the substance that triggers their symptoms – to get a diagnosis. New clinical research published in the journal Gastroenterology has shown a 'game-changer' blood test for gluten-specific T cells that can detect coeliac disease – even when no gluten has been consumed. Currently, people with suspected coeliac are required to eat large amounts of gluten for weeks to get an accurate diagnosis. However, researchers said the new blood test could boost rates of diagnosis, identify patients at risk of severe reactions to gluten and detect silent coeliac disease in asymptomatic people. Coeliac disease is an autoimmune condition where the body attacks its own tissues when gluten is eaten, which prevents normal digestion and absorption of food, with the risk of developing serious health complications. It is driven by eating gluten, a protein found in wheat, barley and rye. An estimated 1 in 100 people have it in the UK. However, only 36 per cent with the condition are clinically diagnosed, according to Coeliac UK. Undiagnosed or untreated coeliac disease can result in complications such as osteoporosis, unexplained infertility, neurological dysfunction and, in rare instances, small bowel cancer, Coeliac UK says. Currently, all coeliac testing methods require regular gluten consumption to be effective, the researchers said. Many people are deterred from seeking a definite diagnosis because they do not want to consume gluten and be sick, the Australia-based scientists added. Associate Professor Jason Tye-Din, Head of WEHI's Coeliac Research Laboratory and a gastroenterologist at the Royal Melbourne Hospital, said: 'There are likely millions of people around the world living with undiagnosed coeliac disease simply because the path to diagnosis is difficult, and at times, debilitating.' 'By eliminating the need for a gluten challenge, we're addressing one of the biggest deterrents in current diagnostic practices,' she added. 'This test could be a game-changer, sparing thousands of people the emotional and physical toll of returning to gluten. It's a major step towards faster, safer diagnosis.' The study evaluated the potential of a blood test to measure an immune marker interleukin 2 (IL-2). In 2019, researchers found this immune marker spiked in the bloodstream of people with coeliac disease shortly after they ate gluten. The scientists used blood samples from 181 volunteers, including 75 people with treated coeliac disease, 13 with active, untreated coeliac disease, 32 people with non-coeliac gluten sensitivity and 61 healthy people. Participant blood samples were then mixed with gluten in a test tube for a day to see if the IL-2 signal appeared. The team was 'thrilled' to find the test could detect the condition with up to 90 per cent sensitivity and 97 per cent specificity – even in patients following a strict gluten-free diet, PhD researcher Olivia Moscatelli, who was diagnosed with coeliac disease at 18, said. The IL-2 signal only increased in the volunteers with coeliac disease, showing the immune response to gluten can be detected in a tube, without the need to consume gluten, researchers said. Ms Moscatelli said the test also performed exceptionally well in people with coeliac disease who had other autoimmune conditions, such as type 1 diabetes or Hashimoto's thyroiditis. The Walter and Eliza Hall Institute team are now collaborating with Novoviah Pharmaceuticals to confirm the test's accuracy across diverse populations and find real-world data.
Time Business News
24-05-2025
- Health
- Time Business News
Understanding Prograf: A Comprehensive Guide to Tacrolimus
Prograf, the brand name for tacrolimus, is a potent immunosuppressant medication primarily used to prevent organ rejection in patients who have undergone liver, kidney, or heart transplants. By inhibiting the body's immune response, Prograf helps ensure the transplanted organ is accepted and functions properly.(PharmaServe, Prograf operates by binding to an intracellular protein known as FKBP-12. This complex then inhibits calcineurin, a crucial enzyme in T-cell activation. As a result, the production of interleukin-2 (IL-2) is suppressed, leading to reduced T-cell proliferation and a weakened immune response .(CenterWatch, Wikipedia) Prograf is primarily prescribed for: Preventing organ rejection in liver, kidney, or heart transplant recipients. in liver, kidney, or heart transplant recipients. Managing ongoing rejection episodes in transplant patients. Treating certain autoimmune conditions, such as lupus nephritis and atopic dermatitis, when other treatments are ineffective.(Houston Chronicle, PharmaServe) The dosage of Prograf is individualized based on the type of transplant, the patient's weight, and blood tacrolimus levels. Typically, it is administered twice daily, either orally or intravenously. It's crucial to take Prograf on an empty stomach, either one hour before or two hours after meals, to ensure optimal absorption .(PharmaServe, Common side effects include: Tremors Headache Nausea and vomiting Diarrhea Hypertension(PharmaServe, Practo) Serious side effects may involve kidney dysfunction, increased risk of infections, and certain cancers. Regular monitoring through blood tests is essential to detect and manage these risks .(PharmaServe) Prograf can interact with various medications, potentially altering its effectiveness or increasing side effects. For instance, drugs that inhibit the enzyme CYP3A, such as ketoconazole, can increase tacrolimus levels, while CYP3A inducers like rifampin can decrease its levels .(PharmaServe) Before starting Prograf, inform your healthcare provider if you have:( Liver, kidney, or heart conditions unrelated to your transplant. A history of diabetes or high blood pressure. Any allergies to tacrolimus or other medications.( Pregnant or breastfeeding women should use Prograf only if absolutely necessary, as it can affect the unborn baby or pass into breast milk .(PharmaServe) Regular follow-up appointments are crucial for patients on Prograf. These visits typically include:( Blood tests to monitor tacrolimus levels and organ function. Assessments for signs of infection or other complications. Adjustments to the dosage based on test results and overall health status. Prograf is a vital medication for transplant recipients, aiding in the prevention of organ rejection. While it offers significant benefits, it's essential to be aware of potential side effects and interactions. Adhering to prescribed dosages, attending regular medical check-ups, and maintaining open communication with healthcare providers can help ensure the best outcomes for patients on Prograf therapy.(Houston Chronicle) TIME BUSINESS NEWS
