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Hoag physicians testing promising options for the diagnosis and treatment of glioblastoma (GBM), the deadliest form of brain cancer NEWPORT BEACH, Calif., Jan. 8, 2025 /PRNewswire/ -- Leading the forefront of neuro-oncology and neuroscience innovation, Hoag Family Cancer Institute and Hoag's Pickup Family Neurosciences Institute are involved in two clinical trials for the diagnosis and treatment of glioblastoma (GBM), a brain tumor with a 5% five-year survival rate. The LIBERATE study (NCT05383872), sponsored by INSIGHTEC, evaluates the use of Focused Ultrasound (FUS) as a way to temporarily open blood-brain barrier (BBB), a protective inner layer of the blood vessels in the brain, to enable liquid biopsies in patients with GBM. Liquid biopsy is an emerging method of collecting and analyzing biomarkers through a simple blood test instead of an invasive surgical biopsy, and the information can be used for more reliable diagnosis and to plan treatment options. For GBM or brain tumor, however, biomarkers are not released into the blood stream because of the BBB. Opening the BBB using FUS may provide a safer and non-invasive approach to brain tumor liquid biopsies. Hoag Family Cancer Institute is one of only 17 sites throughout the U.S. to participate in this trial. Simon Khagi, M.D., Medical Director of Neuro-Oncology at Hoag Family Cancer Institute is serving as the principal investigator of the LIBERATE trial at Hoag. Focused Ultrasound is a noninvasive therapeutic technology with the potential to transform the treatment of many medical conditions by using sound waves, guided by MRI imaging to target tissue deep in the body without incisions or radiation. Hoag acquired Focused Ultrasound technology in part through philanthropic funding provided by Hoag Innovators, a group of philanthropists, entrepreneurs, and community leaders dedicated to catalyzing innovation at Hoag. "Focused Ultrasound has untold potential," says Dr. Khagi. "This approach of opening BBB may allow for targeted delivery of treatment to specific areas in the brain, potentially enhancing treatment outcomes in the future. Low frequency FUS can open the blood-brain barrier for up to 24 hours. During that time, two things can happen: fluid comes out, and we can test it for biomarkers; and treatment can go in. This means that we can effectively deliver treatment to target specific areas in the brain. Most chemotherapy and immunotherapy are unable to fully penetrate the brain to kill brain tumors. Opening the blood-brain barrier would be revolutionary in future clinical trials of cell therapy and immunotherapy." Hoag's Pickup Family Neurosciences Institute is already using FUS for people whose essential tremor or tremor-dominant Parkinson's disease has not responded to medication. "We are seeing immediate results, with no downtime after the procedure," said Christopher M. Duma, M.D., neurosurgeon specialist. "Thanks, in part, to philanthropic support, we are able to purchase the FUS machine, and offer this non-invasive treatment to our patients. We are very proud to lead such innovative treatment approaches at Hoag." "Hoag's dedication to innovation has extended lives and improved the quality of life for the community," said Dr. Robert Louis, who is the Empower360 Endowed Chair in Skull Base and Minimally Invasive Neurosurgery, Chief of the Division of Neurosurgery and Director of the Pituitary & Skull Base Tumor Program in Hoag's Pickup Family Neurosciences Institute. "The use of Focused Ultrasound is just one of many examples of Hoag's promise to our community to provide the treatment options of tomorrow to our patients today," he said. Hoag Family Cancer Institute has also been selected as one of two study sites for the QUILT 3.078 clinical trial, which is studying the investigational immune system enhancing agent N-803 and PD-L1 t-haNK cell therapy both from ImmunityBio, Inc., along with Bevacizumab (Avastin®) for recurrent or progressive glioblastoma (NCT06061809). The Phase 2 study is designed to determine if the combination of N-803, which is currently approved for non-muscle-invasive bladder cancer carcinoma in situ, PD-L1 t-haNK, and Bevacizumab, an immunotherapy currently approved for GBM is safe and slows down the progression of the disease. Study participants receive Bevacizumab and PD-L1 t-haNK intravenously and N-803 is administered subcutanesously via an injection in the abdomen twice a month for up to 18 months. Hoag Family Cancer Institute is involved in a variety of immunotherapy and cell therapy trials evaluating "natural killer," or NK cell therapy, which has shown promise to be beneficial in treating solid tumors. "We are very proud to be one of only two sites in the world running this study using modified natural killer cells for glioblastoma patients," said Dr. Khagi. "We've seen promising results in treating other cancers with this innovative option and are hopeful that it will provide new hope to our patients." Hoag physician leaders believe that the future of GBM treatment will be a multi-modal approach which may include FUS, combined with cell therapy and Optune Gio, a device that generates an electrical field to stop cancer cells from dividing. This approach requires a collaborative team of multidisciplinary experts who are able to work together to advance diagnosis and treatment with patients' best outcomes in mind. Hoag's unique "privademic" model of care, which combines the medical expertise and innovation of a major academic institution with the personalized approach of a private healthcare system sets the hospital apart. The combination of innovation and ability to move quickly brings groundbreaking trials like these to the Orange County community. "We have the expertise here at Hoag that allows us to decide on the best approach for each individual patient," Dr. Khagi said. For information about these clinical trials, please email [email protected] or call 949-764-4577. ABOUT HOAG Hoag is a nonprofit, regional health care delivery system in Orange County, California. Delivering world-class, comprehensive, personalized care, Hoag consists of 1,800 top physicians, 17 urgent care facilities, 11 health & wellness centers, and two award-winning hospitals. Hoag offers a comprehensive blend of health care services that includes seven institutes providing specialized services in the following areas: cancer, digestive health, heart and vascular, neurosciences, spine, women's health, and orthopedics through Hoag's affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and four ambulatory surgical centers. Hoag is the highest ranked hospital in Orange County by U.S. News & World Report and the only OC hospital ranked in the Top 10 in California, as well as a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC). For more information, visit hoag.org. SOURCE Hoag WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio, Inc. ( NASDAQ: IBRX ), a leading immunotherapy company, today announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code assigned by the Centers for Medicare & Medicaid Services (CMS) for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) became effective January 1, 2025. The U.S. Food and Drug Administration (FDA) approved ANKTIVA with Bacillus Calmette-Guérin (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. Healthcare providers may now use the permanent J-code, J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram), when submitting claims for ANKTIVA. J-codes are unique identifiers used by U.S. government and commercial payers, as well as physicians and their office staff, to streamline the billing and reimbursement process for intravesically administered therapies and certain other treatments. “The unique J-code for ANKTIVA is another milestone in our quest to deliver the next generation of immunotherapy beyond T cell activation and enables patients with bladder cancer to benefit from the power of natural killer (NK) cells,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “In approximately 30-40% of patients with NMIBC, standard therapy with BCG will fail, while in 50% of patients who initially respond to BCG, their cancer will come back,” said Richard Adcock, President and CEO of ImmunityBio. “This permanent J-code supports our efforts to increase patient access to ANKTIVA, which in our ongoing QUILT 3.032 study demonstrated a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS, as of November 2024, with a duration of response of up to 54 months.” Since its launch in May 2024, ANKTIVA has become widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies. 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. 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 ImmunityBio.com 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 commercial launch activities and market access initiatives, medical insurance coverage and reimbursement, market data, clinical trial data and potential results 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 and use in cancer vaccines and across multiple tumor types, 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 commercial launch execution, success and timing, (ii) risks and uncertainties regarding market access initiatives and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (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 19, 2024 and the Company’s Form 10-Q filed with the SEC on November 12, 2024, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov . 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.