Latest news with #CancerBioShield
Yahoo
5 days ago
- Business
- Yahoo
ImmunityBio receives FDA Expanded Access authorization for Cancer BioShield
ImmunityBio (IBRX) announced that the U.S. Food and Drug Administration, FDA, has granted Expanded Access authorization for the use of its Cancer BioShield platform, anchored by ANKTIVA, to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on IBRX: Disclaimer & DisclosureReport an Issue ImmunityBio to launch Cancer BioShield in the Middle East Piper upgrades ImmunityBio on Anktiva expansion opportunities ImmunityBio upgraded to Overweight from Neutral at Piper Sandler Short Report: Bears not fearing rebound in Rocket, Avis Budget shares ImmunityBio Sees Revenue Surge Amid Strong Sales Momentum
Yahoo
5 days ago
- 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
5 days ago
- 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
07-04-2025
- Business
- Yahoo
ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch
CULVER CITY, Calif., April 07, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced details about its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company's business operations, U.S. and global regulatory advances of its clinical-stage products, with fireside chats hosted by Dr. Patrick Soon-Shiong and key opinion leaders involved in the company's research programs. The discussions will include clinical and regulatory updates on the company's bladder cancer program, regenerative medicine advanced therapy (RMAT) designations, including results on non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer trials, as well as lymphopenia rescue data related to these trials (Cancer BioShield). In addition, updates will be provided on the natural killer (NK) cell therapy program, the Lynch syndrome accrual and fireside chats on virally induced cancers, including discussions on Long-COVID. The key opinion leaders participating in the fireside chats with ImmunityBio leadership include: Dr. Christopher Pieczonka – Chief Executive Officer, Associated Medical Professionals of New York & Corporate Director of Clinical Research of US Urology Partners Dr. Steven Finkelstein – National Director of Radiation Oncology, US Urology Partners. Director of the Center of Advanced Radiation Excellence (CARE) and Director Radiation Oncology Research Dr. Mark Lanasa – Senior Vice President, Chief Medical Officer, Solid Tumors, BeiGene Dr. Jennifer Buell – President & Chief Executive Officer, MiNK Therapeutics Dr. Krishnansu Tewari – Gynecologic Oncology, Obstetrics & Gynecology at UC Irvine Health Dr. David Kerr - Professor of Cancer Medicine Genetics and Genomics, University of Oxford Dr. Timothy Heinrich – Professor, School of Medicine UC San Francisco Dr. Carlos Cardo-Cardon – Chairman for the Mount Sinai Health System Dept. of Pathology Key timelines for catalysts of product candidates will be presented, along with a discussion of ongoing clinical trials. The program will feature a presentation by ImmunityBio Founder, Executive Chairman and Global Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, outlining the fundamental science underpinning the company's technology platforms. This technology harnesses the immune system to deliver long-term disease protection and prevention. This limited space event will be held in person in El Segundo, California. Individuals wishing to attend in person must RSVP in advance via email (investorday2025@ The event will also be live-streamed. The live stream can be found at: Participant Listening (Listen Only) 1-844-539-3703 or 1-412-652-1273 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 the anticipated date, time, location, subject matter and other information regarding the key opinion leader and investor meeting described herein, anticipated attendees and presenters at the foregoing, ImmunityBio's potential growth trajectory and business prospects, ImmunityBio's beliefs regarding the potential for its approach to revolutionize cancer care, ImmunityBio's manufacturing and production capabilities, 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 and use in cancer vaccines and across multiple tumor types, and ImmunityBio's approved product and its and its collaborators' 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, uncertainties and potential changes in circumstances that may impact ImmunityBio's ability to hold the investor day program as described herein and the anticipated presenters' ability to attend the same, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (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) the risks and uncertainties associated with third party collaborations and agreements, (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 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. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. View source version on Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 MediaSarah Singleton ImmunityBio, Inc. +1
