ImmunityBio Expands Access to ANKTIVA® in EU with New Distribution Partnership and Opens Irish Subsidiary to Support European Launch
- ImmunityBio partner Accord Healthcare to deploy an 85-person sales force to drive ANKTIVA commercialization across 30 countries
- Dublin-based subsidiary to support ImmunityBio's distribution and commercialization strategy in Europe
- Distribution partnership supports ImmunityBio's mission to expand global access to ANKTIVA
- Approximately 157,000 people are diagnosed annually with non-muscle invasive bladder cancer (NMIBC) in the EU and UK, with an estimated 10% to 20% presenting with NMIBC carcinoma in situ, with or without papillary tumors1, 2
- Bladder cancer indication expansion update: response submitted to U.S. FDA for BCG-unresponsive papillary-only disease; randomized BCG naïve trial nearing full enrollment
ImmunityBio, Inc. ((IBRX), a commercial-stage immunotherapy company, today announced a partnership with Accord Healthcare to provide access to ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for eligible patients in the European Union with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease. ImmunityBio also announced the establishment of an Irish subsidiary in Dublin to support the company's distribution and commercialization strategy throughout Europe.
"Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care," said Richard Adcock, President and CEO of ImmunityBio. "Accord's scale, oncology leadership, and commercial reach support our goals to broaden patient access to ANKTIVA and unlock its full commercial potential in Europe."
As part of the partnership, Accord Healthcare will utilize over 100 Sales, Medical, and Marketing professionals to drive commercialization of ANKTIVA in the UK, European Union, as well as European Free Trade Association members Iceland, Liechtenstein, and Norway.
"Our partnership with ImmunityBio reflects our shared commitment to expanding access to innovative cancer therapies for patients in Europe," said Paul Tredwell, Global CEO at Accord Healthcare. "ANKTIVA represents an important advancement for eligible patients with BCG-unresponsive NMIBC CIS, and we are pleased to support its introduction across our markets."
"With approvals now spanning 33 countries, ImmunityBio has expanded global access to ANKTIVA for those with BCG-unresponsive NMIBC CIS, with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The 71% complete response rate and the durability of those responses support ANKTIVA's role as a foundational backbone of next-generation immunotherapy for bladder cancer. Our goal is to further broaden access by rapidly completing the randomized trial in patients with BCG-naïve disease. In parallel, we have submitted our response to the U.S. FDA's request for additional data related to BCG-unresponsive papillary-only NMIBC, and we await the Agency's review."
ANKTIVA in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions, encompassing 33 countries. These approvals include the United States (FDA, April 2024), the United Kingdom (MHRA, July 2025), the Kingdom of Saudi Arabia (SFDA accelerated approval, January 2026), and the European Union, where the European Commission granted conditional marketing authorization in February 2026 covering 27 EU member states plus Iceland, Liechtenstein, and Norway.
About ANKTIVA® (nogapendekin alfa inbakicept)
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist (ATC code: L03AC03) consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. In the European Union, ANKTIVA is available as a 400 µg concentrate for intravesical suspension. ANKTIVA binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, ANKTIVA addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced antitumor activity compared to native IL-15 in vivo.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
WARNINGS AND PRECAUTIONS: The possibility of severe systemic BCG-infections with the necessity of anti-tuberculosis therapy should be considered before initiating the BCG-therapy.
Delaying cystectomy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, treated with ANKTIVA therapy in combination with BCG could lead to development of muscle invasive or metastatic bladder cancer.
If patients with CIS that are medically eligible for cystectomy have not achieved a CR (absence of disease or low-grade Ta) to treatment after an induction course of ANKTIVA in combination with BCG at the 12-weeks assessment, cystectomy should be reconsidered as an alternative to re-induction. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
DOSAGE AND ADMINISTRATION: For intravesical use only. ANKTIVA should NOT be administered by subcutaneous or intravenous or intramuscular use.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
ANKTIVA is administered intravesically as a mixture with BCG.
USE IN SPECIFIC POPULATIONS: Pregnancy: Treatment is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Please see the Summary of Product Characteristics for ANKTIVA® available on the European Medicines Agency website at www.ema.europa.eu.
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 to create durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer 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 sharply reduce or eliminate the need for standard high-dose chemotherapy. For more information, please visit: www.immunitybio.com.
About Accord Healthcare
Accord Healthcare is one of Europe's fastest growing pharmaceutical companies, recognized for its leadership in biosimilars, specialty medicines, with a greater focus in oncology and autoimmune diseases areas.
Having the European headquarters located in the United Kingdom and being part of the global Intas group, Accord is committed to expanding patient access to high quality, affordable treatments across the region. Accord's coverage with any of its available treatments is over 85 countries around the world and gives support to multiple national health systems supporting healthcare professionals to transform patient lives worldwide.
Its rapidly growing portfolio, supported by strong research, development, and manufacturing capabilities, addresses areas of high clinical need. Additionally, through strategic expansion, including tactical partnerships and acquisitions, Accord delivers impactful therapies across all EU member states and the EEA.
Agile and inventive, the company blends global reach with patient focused innovation to improve healthcare outcomes worldwide.
Visit our UK website or our Global website to find out more about us.
- European Association of Urology. EAU Guidelines on Muscle-invasive and Metastatic Bladder Cancer. Limited Update March 2025. Available at https://uroweb.org/guidelines/muscle-invasive-and-metastatic-bladder-cancer/chapter/epidemiology-aetiology-and-pathology
- Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: https://actionbladdercanceruk.org/library/files/ABCUK%20An%20Introduction%20to%20NMIBC%20May%202021.pdf
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, without limitation, our expectations regarding the anticipated commercial rollout of ANKTIVA® throughout the European Union and United Kingdom, the projected impact of the newly formed Irish subsidiary on our distribution capabilities, the expected timing and outcomes of additional regulatory submissions and post-approval commitments, the expected benefits of the distribution partnership covering the European Union and the United Kingdom; anticipated market access, commercial performance, revenue potential, and growth opportunities; expected timelines for regulatory, launch, and commercialization activities; the ability of the parties to successfully collaborate and negotiate and execute under the agreement; the potential impact of the partnership on the company's long term strategic objectives.
These forward-looking statements are based on current expectations, assumptions, and projections that involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include among others: the ability to obtain and maintain required regulatory approvals; pricing, reimbursement, and market access challenges across the EU member states and the UK; variability in demand or adoption by healthcare providers and patients; supply chain, manufacturing, and distribution risks; performance and compliance of our commercial partner; competitive pressures; changes in healthcare laws, regulations, or trade policies; foreign currency fluctuations; geopolitical or economic conditions in the region; and other risks related to international commercialization of a innovative biologic product.
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 November 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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