Initial Data Shows 100% Disease Control in 5 Out of 5 Patients With Recurrent Glioblastoma With Two Patients in Near Complete Response Treated With ImmunityBio’s ANKTIVA®, NK Cell Therapy Plus Optune Gio® Device

• First chemotherapy-free trial combining ANKTIVA, an IL-15 agonist, natural killer (NK) cell therapy, and Optune immune-stimulating device for patients with glioblastoma (GBM) brain tumors who have failed current standard of care
• Encouraging early results observed to date, including response in 3 of the subjects with 2 responders at near complete response and 2 with ongoing stable disease, representing 100 percent disease control 
• ANKTIVA treatment increased absolute lymphocyte count (ALC) in all five patients who had experienced lymphopenia after standard of care radiation and chemotherapy
• Based on these early findings, ImmunityBio is initiating a randomized trial targeting second-line GBM patients who have recurring disease following standard of care
• Approximately 12,000 Americans are diagnosed annually with GBM, according to the American Brain Tumor Association, making it one of the most common types of brain tumor¹
• GBM, which is typically diagnosed in older individuals, has the lowest five-year survival rate of any common brain tumor—just 9% for patients aged 45-54 and 6% for ages 55-64, according to the American Cancer Association²

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced early findings from the first five recurrent glioblastoma patients treated with its investigational immune-boosting regimen including ANKTIVA^® (nogapendekin alfa inbakicept-pmln) in this pilot study (NCT06061809). All five patients achieved 100% disease control with the regimen that combines ANKTIVA, an IL-15 agonist being studied for its ability to enhance natural killer (NK) cell activity, NK cell therapy (PD-L1 t-haNK), and Optune Gio Tumor Treating Fields. Of the 5 patients treated to date, 3 responded of which 2 at near complete response and the remaining 2 having stable disease to date. This finding of 5 out of 5 (100%) disease control in 2^nd line recurrent glioblastoma receiving a chemotherapy free immunotherapy with Optune immune stimulating device is highly encouraging.

We believe these early results of this combination immune-stimulating therapy are notable, given both the fact that GBM is a common form of brain tumor, as well as one that is exceptionally difficult to treat successfully with currently approved therapies. GBM has a single digit five-year survival rate for patients aged 45 and over. While the initial treatments in this trial involve a small cohort, the results are sufficiently encouraging for the company to plan a Phase 2 trial in second-line glioblastoma to further evaluate the potential for this combination treatment.

“GBM is a devastating type of brain cancer for which there are currently no durable treatment options, which is why this study has such important potential,” said Dr. Simon Khagi, Medical Director of Neuro-Oncology at the Hoag Family Cancer Institute, and the Principal Investigator for this study. “In my years of treating patients with glioblastoma I have never experienced these near complete responses as well as the rapidity of the response as seen in these patients to date,” he further stated. “There has been little advance in therapy for decades for glioblastoma. This chemotherapy free, immune-stimulating combination approach with ANKTIVA is highly promising and may represent a fundamental advance in therapy in patients with tumors of the brain.”

“Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM,” added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “There is compelling evidence that ANKTIVA’s mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand. We believe these preliminary results in patients with GBM, whose lymphocyte counts (NK and T cells) are low as a consequence of radiation and chemotherapy after first-line treatment, can be rescued following ANKTIVA and NK cell therapy, and warrant the rapid expansion of this study in recurrent glioblastoma.”

To learn more about this glioblastoma trial visit clinicaltrials.gov/study/NCT06061809 and cssifm.org

ANKTIVA, which is approved by the U.S. Food and Drug Administration with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, is being evaluated alone and with other agents in multiple studies for non-small cell lung cancer, non-Hodgkin lymphoma, Lynch syndrome (hereditary colon cancer), ovarian cancer and Human Papillomavirus (HPV) associated tumors. ANKTIVA is also being studied in Human Immunodeficiency Virus (HIV) and lymphopenia.

To learn more about ImmunityBio’s clinical trials, visit immunitybio.com/find-a-trial/ and cssifm.org.

Optune Gio^® is a registered trademark of Novocure GmbH.

About ANKTIVA^® (nogapendekin alfa inbakicept-pmln)

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. A key component in the company’s BioShield platform, 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 driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated 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.

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 patients 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 Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Prescribing Information for ANKTIVA^® at Anktiva.com.

References:

1. American Brain Tumor Association. Glioblastoma (GBM). June 2024. Available at https://www.abta.org/tumor_types/glioblastoma-gbm/
2. American Cancer Association. Survival Rates for Selected Adult Brain and Spinal Cord Tumors. May 2020. Available at https://www.cancer.org/cancer/types/brain-spinal-cord-tumors-adults/detection-diagnosis-staging/survival-rates.html

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 ImmunityBio.com (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 potential implications to be drawn from preliminary clinical study results, clinical trial enrollment, timing, data and potential results to be drawn therefrom, anticipated components of ImmunityBio’s CancerBioShield™ platform, the anticipated Phase 2 clinical trial referenced herein, potential patient populations and implications thereof, 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 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 have 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 participation and enrollment and potential results and data from the clinical trial described herein, including whether the preliminary data from this early stage pilot study will hold and ultimately yield clinical response and results, of which there can be no assurance, (ii) whether clinical trials will result in registrational pathways, (iii) whether clinical trial data will be accepted by regulatory agencies, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) 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, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, (xii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies, and (xiii) whether planned clinical trials including the proposed Phase 2 clinical trial described herein will receive regulatory authorization and enroll on a timely basis, if at all. 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 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.

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ImmunityBio Contacts:

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com



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Sarah Singleton

ImmunityBio, Inc.

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Sarah.Singleton@ImmunityBio.com

Source: ImmunityBio, Inc.