Latest news with #ImmunityBio
Medscape
2 days ago
- Health
- Medscape
MHRA Approves New Immunotherapy for Bladder Cancer
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved nogapendekin alfa inbakicept (Anktiva, ImmunityBio) for use in adults with carcinoma in situ (CIS) non-muscle-invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG). Approval applies to patients who are either ineligible for or decline cystectomy. Inbakicept is administered in combination with BCG. It is not a replacement for BCG but acts as a complementary agent. The therapy enhances immune system activity by stimulating CD8+ T cells and natural killer cells, while avoiding the activation of regulatory T cells. Durable Response Demonstrated in Clinical Trial The approval was supported by data from the phase 2/3 QUILT-3.032 trial, which enrolled patients with BCG-unresponsive NMIBC with CIS. The trial showed a complete response (CR) rate of 71%, with a median duration of 26.6 months. Among patients achieving CR, 58% maintained it for at least 12 months, and 40% remained disease-free at 24 months. Overall, 62% of patients with CIS achieved CR during treatment. The treatment also demonstrated a significant bladder-sparing effect, with a 90% probability of avoiding cystectomy in responders at 24 months. Treatment involves direct instillation into the bladder via catheter. Patients receive weekly induction doses for 6 weeks, followed by maintenance doses at months 4, 7, 10, 13, and 19. Safety Profile The most common adverse events were urinary in nature and included dysuria, haematuria, urinary frequency, and urinary tract infections. Most were mild to moderate in severity. Dr Patrick Soon-Shiong, executive chairman and global chief scientific officer at ImmunityBio, said the therapy offers 'a meaningful option for BCG-unresponsive NMIBC.' The approval was granted through the International Recognition Procedure, with Serum Life Science Europe GmbH as the marketing authorisation holder. Full prescribing information, including the Patient Information Leaflet and Summary of Product Characteristics, will be published on the MHRA website within 7 days of approval. Healthcare professionals and patients are encouraged to report any adverse events through the Yellow Card scheme.
Yahoo
2 days ago
- Business
- Yahoo
UK MHRA Approves ImmunityBio's ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping eliminate cancer Already approved in the U.S. and designated as a Breakthrough Therapy by the FDA, this marks ANKTIVA's first marketing approval outside the U.S. ANKTIVA plus BCG offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with NMIBC in the UK each year1 CULVER CITY, Calif., July 08, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent. "With the MHRA's authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control." "ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK," said Richard Adcock, CEO and President of ImmunityBio. ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform's effectiveness can be monitored using a routine complete blood count (CBC). ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months. As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group. ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein. About NMIBC CIS Bladder cancer is the 10th most commonly-diagnosed cancer globally,2 and in the UK, the Action Bladder Cancer UK estimates approximately 23,000 patients are diagnosed annually.1 At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall.3 The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of Bacillus Calmette-Guerin (BCG).4,5 BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur.6 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 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, 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 BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit INDICATION AND IMPORTANT SAFETY INFORMATION FROM THE FDA LABEL INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. For more information about ANKTIVA, please see the Full Prescribing Information at You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482) About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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 natural killer 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. References: Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: World Cancer Research Fund. Bladder Cancer Statistics. 2022. Available at: Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Canadian Urological Association Journal, 4(1), 56–64. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846. Grabe-Heyne, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023 Jun 2;13:1170124. doi: 10.3389/fonc.2023.1170124. Kodera A, Mohammed M, Lim P, Abdalla O, Elhadi M. The Management of Bacillus Calmette-Guérin (BCG) Failure in High-Risk Non-muscle Invasive Bladder Cancer: A Review Article. Cureus. 2023 Jun 26;15(6):e40962. doi: 10.7759/cureus.40962. PMID: 37503461; PMCID: PMC10369196. 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, the belief that the MHRA authorization leads to increased revenue, the expectation that the EAP as previously reported will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, 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, and the impact of the MHRA on the Company's ex-United States go to market strategy, including in light of the recently implemented United States Most Favored Nation pricing policy on the Company's go-to-market strategy in the United Kingdom, 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 regulatory submissions in foreign jurisdictions, filing and review process and the timing thereof, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding commercial launch execution, success and timing, (v) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (vi) whether clinical trials will result in registrational pathways and the risks, (vii) whether clinical trial data will be accepted by regulatory agencies, (viii) 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, (iv) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) 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 May 12, 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. View source version on Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio, Inc. +1 Sign in to access your portfolio
Business Wire
2 days ago
- Business
- Business Wire
UK MHRA Approves ImmunityBio's ANKTIVA ® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent. 'With the MHRA's authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control.' 'ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK,' said Richard Adcock, CEO and President of ImmunityBio. ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform's effectiveness can be monitored using a routine complete blood count (CBC). ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months. As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group. ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein. About NMIBC CIS Bladder cancer is the 10th most commonly-diagnosed cancer globally, 2 and in the UK, the Action Bladder Cancer UK estimates approximately 23,000 patients are diagnosed annually. 1 At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall. 3 The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of Bacillus Calmette-Guerin (BCG). 4,5 BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur. 6 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 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, 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 BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit INDICATION AND IMPORTANT SAFETY INFORMATION FROM THE FDA LABEL INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. For more information about ANKTIVA, please see the Full Prescribing Information at You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482) About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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 natural killer 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. References: Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: World Cancer Research Fund. Bladder Cancer Statistics. 2022. Available at: Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Canadian Urological Association Journal, 4(1), 56–64. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846. Grabe-Heyne, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023 Jun 2;13:1170124. doi: 10.3389/fonc.2023.1170124. Kodera A, Mohammed M, Lim P, Abdalla O, Elhadi M. The Management of Bacillus Calmette-Guérin (BCG) Failure in High-Risk Non-muscle Invasive Bladder Cancer: A Review Article. Cureus. 2023 Jun 26;15(6):e40962. doi: 10.7759/cureus.40962. PMID: 37503461; PMCID: PMC10369196. 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, the belief that the MHRA authorization leads to increased revenue, the expectation that the EAP as previously reported will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, 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, and the impact of the MHRA on the Company's ex-United States go to market strategy, including in light of the recently implemented United States Most Favored Nation pricing policy on the Company's go-to-market strategy in the United Kingdom, 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 regulatory submissions in foreign jurisdictions, filing and review process and the timing thereof, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding commercial launch execution, success and timing, (v) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (vi) whether clinical trials will result in registrational pathways and the risks, (vii) whether clinical trial data will be accepted by regulatory agencies, (viii) 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, (iv) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) 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 May 12, 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
07-06-2025
- Business
- Yahoo
ASCO Report of Pioneering Treatment of Lymphopenia with Significant Overall Survival Benefit in Advanced Pancreatic Cancer
While Epogen and Neupogen addresses anemia and neutropenia, no therapy has existed for the treatment of lymphopenia until ANKTIVA® –The Cancer BioShield. Landmark overall survival benefit (P-value 0.005, HR: 0.46 [0.26, 0.80]) observed in 3rd-6th line metastatic pancreatic cancer, correlated with reversal of lymphopenia. Patients with lower tumor burden and improved lymphocyte counts (ALC ≥1,000) had a median overall survival of 10.1 months, supporting earlier intervention in the disease course. CULVER CITY, Calif., June 03, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced results presented at ASCO 2025 of the first known treatment for lymphopenia with ANKTIVA and CAR-NK therapy. This data supports that reversal of lymphopenia, a well-established root cause of early mortality in patients with cancer across all tumor types, correlates with significant improved survival. While anemia and neutropenia have long been addressed by agents like Epogen and Neupogen, no therapy has ever existed for lymphopenia—until now. ANKTIVA (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist approved in April 2024 for BCG-unresponsive non-muscle- invasive bladder cancer carcinoma in situ with or without papillary disease, represents the first lymphocyte-stimulating agent (LSA) capable of expanding lymphocytes critical for immunogenic cell death, such as natural killer (NK) and T cells. These findings emphasize the need for a therapy to overcome treatment induced lymphopenia with higher mortality as presented at ASCO 2025 by several institutions (Abstract #8054, Satoskar et al. and Abstract #2663, Saleh et al.) In a single-arm QUILT-88 clinical trial of 86 participants with third-to-sixth-line metastatic pancreatic cancer with very high tumor burden (CA19-9 levels exceeding 34,000 IU/ml), for which no therapy currently exists, patients received ANKTIVA subcutaneously in combination with off-the-shelf, ex-vivo infusion of CAR-NK cells (PD-L1 t-haNK) and low dose immuno-modulating chemotherapy. This first reported study of treating lymphopenia demonstrated significant differences in median overall survival in subjects whose lymphopenia was reversed (Absolute Lymphocyte Count: ALC ≥ 1,000). In 67 out of 86 subjects, reversal of lymphopenia was achieved and median overall survival was significantly prolonged compared to those who remained in severe lymphopenia with P-value 0.005, HR: 0.46 (0.26, 0.80) in Figure 1. In subjects with lymphopenia rescue and a lower tumor burden (less than the median CA19-9 of 34,000 IU/mL), the median overall survival in these very advanced metastatic pancreatic cancer patients exceeded 10 months (Figure 2). These findings of improved survival in pancreatic cancer patients with lower tumor burden point to the potential of further prolonged overall survival in pancreatic cancer patients if treated in the first line or neoadjuvant stages of disease. Highlighting the importance of lymphopenia reversal, Oncologist published a peer-reviewed paper titled "Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate," demonstrating that in a patient with 2nd line metastatic pancreatic cancer treated with the full Cancer BioShield platform—including ANKTIVA, CAR-NK cells (PD-L1 t-haNK), and antigen-targeting adenoviruses—remained in remission for over six years and maintains a high quality of life at the date of this release. The expanded access authorization announced yesterday enables patients across all solid tumor types who have exhausted first-line therapy including chemotherapy, radiation, or immunotherapy to receive Anktiva as a lymphocyte stimulating agent to protect the immune system from the lymphogenic adverse effects of current standards of care. The ASCO Annual Meeting 2025 materials from ImmunityBio can be found below: Association of lymphopenia rescue and CA19-9 levels with overall survival following IL-15 superagonist N-803 and PD-L1 t-haNK chemo-immunotherapy for 3rd line or greater metastatic pancreatic Text: Poster PDF: About the Cancer BioShield™ Platform The Cancer BioShield platform is a first-in-class immunotherapy strategy designed to restore immune competence by reversing lymphopenia—the loss of functional immune cells caused by cancer itself and by conventional treatments such as chemotherapy, radiation and immunotherapy. At its core is ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 agonist approved for BCG-unresponsive non-muscle-invasive bladder cancer CIS with or without papillary disease, activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells, restoring lymphocyte levels critical for immunosurveillance, immunogenic cell death, and long-term tumor control. The platform employs a multi-modal approach: In-vivo stimulation: Subcutaneous administration of ANKTIVA expands NK and T cells, boosting anti-tumor immunity. Ex-vivo targeted cytotoxicity: Off-the-shelf PD-L1 t-haNK CAR-NK cells are engineered to target and eliminate PD-L1–expressing tumor cells and immunosuppressive neutrophils (myeloid-derived suppressor cells), enhancing anti-tumor specificity and reducing immune evasion. Memory Cytokine-Enriched Natural Killer (M-ceNK) cell therapy: M-ceNK cells are developed via cytokine activation and expansion of autologous and allogeneic NK cells collected through apheresis, potentially providing long-term immune memory and sustained cytotoxic capacity. Together, these components offer a comprehensive, novel, immune-restoring therapeutic platform aimed at not only expanding effector immune cells but also overcoming tumor-mediated immune suppression to support long-term disease control. The platform's effectiveness can be tracked through universally utilized, simple complete blood count (CBC): increases in absolute lymphocyte count (ALC) reflect ANKTIVA's lymphocyte-stimulating activity, while reductions in the neutrophil-to-lymphocyte ratio (NLR) demonstrate PD-L1 t-haNK's immunosuppressive neutrophil targeting. Low ALC and high NLR levels are laboratory measurements that have been extensively reported as predictive biomarkers of poor prognosis with early mortality across all tumor types5,6. The data presented by ImmunityBio for the first time demonstrates that improving ALC and NLR correlates with significant enhanced overall survival and clinical benefit. About Lymphopenia and Absolute Lymphocyte Count (ALC) Lymphopenia—the loss of key immune cells such as NK, CD4+, and CD8+ T cells—is a common side effect of chemotherapy1, radiation2,3, and some immunotherapies4. Unlike anemia and neutropenia, which have FDA-approved treatments like EPO and Neupogen, no therapy previously existed to treat this immune cell depletion. Lymphopenia weakens the immune system, increases infection risk, and is linked to early death across many cancer types5. Low Absolute Lymphocyte Count (ALC) is a recognized poor prognostic marker. ANKTIVA® is the first approved therapy to restore lymphocyte levels by activating and expanding NK and T cells—without increasing immunosuppressive T regulatory cells7. More information on lymphopenia could be found on Twitter/X @DrPatSoonShiong articles here: References: Ray-Coquard I, et al. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/ Epub 2009 Jun 23. PMID: 19549917; PMCID: PMC2775079. Chen D, et al. Absolute Lymphocyte Count Predicts Abscopal Responses and Outcomes in Patients Receiving Combined Immunotherapy and Radiation Therapy: Analysis of 3 Phase 1/2 Trials. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):196-203. doi: 10.1016/ Epub 2020 Feb 7. Pike LRG, et al. The Impact of Radiation Therapy on Lymphocyte Count and Survival in Metastatic Cancer Patients Receiving PD-1 Immune Checkpoint Inhibitors. Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):142-151. doi: 10.1016/ Epub 2018 Sep 15. PMID: 30227198. Lee, Y.J., et al. Peripheral lymphocyte count as a surrogate marker of immune checkpoint inhibitor therapy outcomes in patients with non-small-cell lung cancer. Sci Rep 12, 626 (2022). Ménétrier-Caux C., et al. Lymphopenia in Cancer Patients and its Effects on Response to Immunotherapy: an opportunity for combination with Cytokines? J Immunother Cancer. 2019 Mar 28;7(1):85. doi: 10.1186/s40425-019-0549-5. PMID: 30922400; PMCID: PMC6437964. Templeton AJ, et al. Prognostic role of neutrophil-to-lymphocyte (NLR) ratio in solid tumors: a systematic review and meta-analysis. J Natl Cancer Inst. 2014 May 29;106(6):dju124. doi: 10.1093/jnci/dju124. PMID: 24875653. FDA ANKTIVA Label, April 2024 - About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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 natural killer 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, the expectation that the EAP described herein will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, 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) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iii) risks and uncertainties regarding commercial launch execution, success and timing, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (v) whether clinical trials will result in registrational pathways and the risks, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) 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, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio's ability to retain and hire key personnel, (x) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) 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 May 12, 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. View source version on Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio, Inc. +1 Sign in to access your portfolio
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06-06-2025
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Why ImmunityBio, Inc. (IBRX) Skyrocketed Today
We recently published a list of . In this article, we are going to take a look at where ImmunityBio, Inc. (NASDAQ:IBRX) stands against other Wednesday's best-performing stocks. ImmunityBio extended its winning streak to a fifth consecutive day on Wednesday, jumping 8.1 percent to finish at $2.93 apiece as investors cheered the Food and Drug Administration's (FDA) green light for the company to expand the access of its Anktiva treatment to patients with solid tumors. According to ImmunityBio, Inc. (NASDAQ:IBRX), it was granted by the FDA to treat lymphopenia in adult patients with refractory or relapsed solid tumors. 'Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed,' said ImmunityBio, Inc. (NASDAQ:IBRX) founder and Executive Chairman Patrick Soon-Shiong. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. 'This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA. The survival benefit we observed at ASCO 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels, rather than depleting them, can change the course of disease.' Following the announcement, the company earned a 'buy' recommendation and a price target of $8 from investment firm HC Wainwright. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. 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
