Latest news with #IL-15
Business Wire
11-08-2025
- Health
- Business Wire
ImmunityBio Announces Houston's Michael E. DeBakey VA Medical Center Is Among the First VA Hospitals to Administer ANKTIVA ® to Bladder Cancer Patients
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center in Houston recently became the first VA hospital in the Houston region and one of the first in the U.S. to provide treatment with ANKTIVA ® (nogapendekin alfa inbakicept-pmln) to a veteran with bladder cancer. ANKTIVA, the first of its kind immune-boosting, lymphocyte stimulating agent, is approved by the U.S. Food and Drug Administration (FDA) in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). A 2024 study found military exposure to carcinogenic agents was associated with a higher risk for bladder cancer among veterans, making this treatment especially vital for those at the VA. Nationally recognized urologic oncologists at the Houston VA, Dr. Jeffrey Jones and Dr. Jennifer Taylor, were instrumental in bringing this novel treatment to veterans. They are strong advocates for advancing care for those battling bladder cancer. In addition, Dr. Jones, who is also affiliated with Baylor College of Medicine, led efforts to enroll the facility in ImmunityBio's Expanded Access Program (EAP) for rBCG. 'We are honored to see ANKTIVA reaching our nation's veterans,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'Drs. Jones' and Taylor's leadership and commitment to innovation are exactly what's needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission.' About ANKTIVA The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15Rα, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA, which confers stability and longer half-life than recombinant or native IL-15, mimics the natural biological properties of the membrane-bound IL-15Rα, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 for use in the United States with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. For more information, visit (Founder's Vision) and About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial data and potential results and implications to be drawn therefrom, treatment of patients at VA Medical Centers and in certain geographic locations and potential implications to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'goal,' 'could,' 'estimates,' 'scheduled,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'indicate,' 'projects,' 'is,' 'seeks,' 'should,' 'will,' 'strategy,' and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding commercial launch execution, success and timing and market access initatives, (iii) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (iv) whether clinical trials will result in registrational pathways and the risks, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vii) potential delays in product availability and regulatory approvals, (viii) ImmunityBio's ability to retain and hire key personnel, (ix) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading 'Risk Factors' in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on August 5, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof.
Yahoo
03-06-2025
- Business
- Yahoo
FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia
The US Food and Drug Administration (FDA) has granted expanded access authorisation for ImmunityBio's Cancer BioShield platform, anchored by Anktiva (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adults with refractory or relapsed solid tumours. The approval applies regardless of tumour type and is intended for those who have progressed after first-line standard-of-care treatments, including radiation, chemotherapy or immunotherapy. Lymphopenia refers to the depletion of critical lymphocytes that are responsible for immunogenic cell death. Treatment-induced lymphopenia can be a consequence of radiation therapy, chemotherapy and certain immunotherapies, as well as steroids. Anktiva is designed specifically to address Bacille Calmette-Guérin (BCG)-unresponsive bladder cancer through its mechanism as an interleukin-15 (IL-15) superagonist that proliferates key lymphocytes. As an IL-15 agonist, Anktiva becomes the first approved therapy with a defined mechanism aimed at restoring levels of the vital immune cells without inducing regulatory T cells, thus providing a solution to reverse this critical immune deficit among cancer patients. Recent results have indicated that reversing lymphopenia using both Anktiva and chimeric antigen receptor-natural killer therapy prolongs median overall survival rates among patients with third to sixth-line metastatic pancreatic cancer. Enhanced benefits were observed when treatment commenced at lower tumour burdens indicated by CA19-9 levels. ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: 'Lymphopenia has long been recognised as a major driver and predictor of early mortality in cancer — yet until now, it has remained unaddressed. 'This FDA authorisation allows all patients with solid tumours suffering from immune collapse following first-line therapy of chemo, radiation or immunotherapy to access Anktiva.' In February 2025, ImmunityBio announced the receipt of regenerative medicine advanced therapy designation from the FDA concerning both Anktiva and CAR-NK. "FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
03-06-2025
- Business
- Yahoo
FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia
The US Food and Drug Administration (FDA) has granted expanded access authorisation for ImmunityBio's Cancer BioShield platform, anchored by Anktiva (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adults with refractory or relapsed solid tumours. The approval applies regardless of tumour type and is intended for those who have progressed after first-line standard-of-care treatments, including radiation, chemotherapy or immunotherapy. Lymphopenia refers to the depletion of critical lymphocytes that are responsible for immunogenic cell death. Treatment-induced lymphopenia can be a consequence of radiation therapy, chemotherapy and certain immunotherapies, as well as steroids. Anktiva is designed specifically to address Bacille Calmette-Guérin (BCG)-unresponsive bladder cancer through its mechanism as an interleukin-15 (IL-15) superagonist that proliferates key lymphocytes. As an IL-15 agonist, Anktiva becomes the first approved therapy with a defined mechanism aimed at restoring levels of the vital immune cells without inducing regulatory T cells, thus providing a solution to reverse this critical immune deficit among cancer patients. Recent results have indicated that reversing lymphopenia using both Anktiva and chimeric antigen receptor-natural killer therapy prolongs median overall survival rates among patients with third to sixth-line metastatic pancreatic cancer. Enhanced benefits were observed when treatment commenced at lower tumour burdens indicated by CA19-9 levels. ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: 'Lymphopenia has long been recognised as a major driver and predictor of early mortality in cancer — yet until now, it has remained unaddressed. 'This FDA authorisation allows all patients with solid tumours suffering from immune collapse following first-line therapy of chemo, radiation or immunotherapy to access Anktiva.' In February 2025, ImmunityBio announced the receipt of regenerative medicine advanced therapy designation from the FDA concerning both Anktiva and CAR-NK. "FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
Hamilton Spectator
27-05-2025
- Health
- Hamilton Spectator
Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA
TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat serious conditions and address unmet medical needs. 'The FDA's decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease,' said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. 'Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.' TEV-53408 is an antibody designed to inhibit the activity of the cytokine, interleukin-15 (IL-15), to prevent intestinal damage and associated symptoms in individuals with celiac disease. This potential treatment is a testament to the growing strength of Teva's innovative pipeline and dedication to advancing treatments for immunological conditions, including celiac disease, which affects approximately 1% of the global population.1-3 About TEV-53408 TEV-53408 is an investigational monoclonal antibody that inhibits interleukin-15 (IL-15), which aims to reduce the immune response to gluten that causes intestinal inflammation and damage in individuals with celiac disease. A Phase 2a study investigating the efficacy and safety of anti-IL-15 in adults with celiac disease is ongoing ( NCT06807463 ). About Celiac Disease Celiac disease is a chronic autoimmune disorder triggered by gluten, affecting the small intestine and leading to a range of symptoms. It can significantly impact an individual's quality of life, and diagnosis can be challenging. A strict, lifelong gluten-free diet is the only current treatment and even if adhering to a gluten-free diet, a significant proportion of patients still experience debilitating symptoms. In addition, trace amounts of gluten - especially through accidental or inadvertent ingestion - can cause severe reactions. Teva is dedicated to developing innovative medicines for immunological diseases, including celiac disease, with the goal of providing better health for people suffering from celiac disease worldwide. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our anti-IL 15 (TEV-53408) asset for the treatment of people with celiac disease on a gluten-free diet; the risk that we will incur significant costs in connection with the development of anti-IL 15 (TEV-53408), which may exceed any revenue generated by anti-IL 15 (TEV-53408); risks that regulatory approvals and other requirements may delay the development and commercialization of our anti-IL 15 (TEV-53408); our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 'Risk Factors and 'Forward Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. References Teva Media Inquiries TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquires TevaIR@
Yahoo
27-05-2025
- Business
- Yahoo
Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA
Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibody Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac disease Candidate demonstrates Teva's commitment to bringing important new treatment options to underserved patient populations TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat serious conditions and address unmet medical needs. 'The FDA's decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease,' said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. 'Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.' TEV-53408 is an antibody designed to inhibit the activity of the cytokine, interleukin-15 (IL-15), to prevent intestinal damage and associated symptoms in individuals with celiac disease. This potential treatment is a testament to the growing strength of Teva's innovative pipeline and dedication to advancing treatments for immunological conditions, including celiac disease, which affects approximately 1% of the global population.1-3 About TEV-53408 TEV-53408 is an investigational monoclonal antibody that inhibits interleukin-15 (IL-15), which aims to reduce the immune response to gluten that causes intestinal inflammation and damage in individuals with celiac disease. A Phase 2a study investigating the efficacy and safety of anti-IL-15 in adults with celiac disease is ongoing (NCT06807463). About Celiac Disease Celiac disease is a chronic autoimmune disorder triggered by gluten, affecting the small intestine and leading to a range of symptoms. It can significantly impact an individual's quality of life, and diagnosis can be challenging. A strict, lifelong gluten-free diet is the only current treatment and even if adhering to a gluten-free diet, a significant proportion of patients still experience debilitating symptoms. In addition, trace amounts of gluten - especially through accidental or inadvertent ingestion - can cause severe reactions. Teva is dedicated to developing innovative medicines for immunological diseases, including celiac disease, with the goal of providing better health for people suffering from celiac disease worldwide. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our anti-IL 15 (TEV-53408) asset for the treatment of people with celiac disease on a gluten-free diet; the risk that we will incur significant costs in connection with the development of anti-IL 15 (TEV-53408), which may exceed any revenue generated by anti-IL 15 (TEV-53408); risks that regulatory approvals and other requirements may delay the development and commercialization of our anti-IL 15 (TEV-53408); our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 'Risk Factors and 'Forward Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. References Gatti S, Rubio-Tapia A, Makharia G, Catassi C. Patient and Community Health Global Burden in a World with More Celiac Disease. Gastroenterology. 2024;167(1):23-33. Singh, Prashant et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology, 2018; 16(6), 823 - 836.e2 Mustalahti, K., Catassi, C., Reunanen, A., Fabiani, E., Heier, M., … McMillan, S. (2010). The prevalence of celiac disease in Europe: Results of a centralized, international mass screening project. Annals of Medicine, 2010; 42(8), 587–595. Teva Media Inquiries TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquires TevaIR@ in to access your portfolio
