ImmunityBio Partners with Saudi Arabia to Bring FDA-Approved Cancer BioShield Platform to Middle East
核心洞察
ImmunityBio signed a strategic MOU with Saudi Arabia's Ministry of Investment, KFSHRC, and KAIMRC to introduce the FDA-approved Cancer BioShield platform to the Middle East region.
The BioShield platform, powered by Anktiva (nogapendekin alfa inbakicept), represents the world's first FDA-approved IL-15 (搜索) superagonist that activates natural killer cells and T cells rather than suppressing them like conventional treatments.
This collaboration aims to establish a regional center of excellence for immune-restorative therapies, addressing lymphopenia as the root cause of cancer mortality rather than treating cancer as the primary disease.
ImmunityBio, Inc. has announced a strategic partnership with Saudi Arabian institutions to introduce its FDA-approved Cancer BioShield platform to the Middle East, marking a significant expansion of immune-restorative cancer therapies in the region. The Memorandum of Understanding (MOU) was signed with the Ministry of Investment of Saudi Arabia (MISA), King Faisal Specialist Hospital & Research Centre (KFSHRC), and King Abdullah International Medical Research Center (KAIMRC) during the Saudi-U.S. Investment Forum 2025 in Riyadh.
Revolutionary Approach to Cancer Treatment
The BioShield platform represents a paradigm shift in cancer care, powered by Anktiva® (nogapendekin alfa inbakicept)—the world's first FDA-approved IL-15 (搜索) superagonist designed to proliferate natural killer (NK) and T cells. Unlike conventional treatments including chemotherapy and radiation that kill and suppress natural killer immune cells and thus paradoxically catalyze further spread, the BioShield protects and activates the immune system's natural killer cells and T cells to restore immune function and prolong life.
Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio, emphasized the transformative nature of this technology: "The BioShield platform changes the way we think about treating cancer—not by destroying the immune system but by restoring and activating it. The root cause of early mortality is the collapse of the immune system—lymphopenia is the disease, and cancer is a symptom."
Addressing Lymphopenia as Root Cause
For the first time in medicine, physicians can address the long-overlooked impact of lymphopenia (loss of NK and T cells), induced by current standards of care of chemotherapy, radiation, or by the cancer itself. The BioShield is the first therapy in history to specifically address the protection and restoration of lymphocytes, represented by NK, CD8 (搜索), and CD4 (搜索) T cells—the most important cells in the body needed to fight cancer and infection.
Treating lymphopenia is positioned as an answer to premature death from life-threatening diseases such as cancer and sepsis and, potentially, to aging and longevity in health.
Strategic Regional Partnership
His Excellency Khalid A. AlFalih, Minister of Investment, Saudi Arabia, highlighted the Kingdom's commitment to biotechnology leadership: "This partnership reflects the Kingdom's commitment to positioning itself as a global hub in the biotechnology sector in advanced therapeutics. Through this collaboration, we will localize cutting-edge technologies, build biomanufacturing capabilities, and enhance our national biotechnology infrastructure and human capabilities in alignment with the objectives of the National Biotech Strategy."
The MOU enables active engagement between the parties and includes provisions to establish Middle East subsidiaries, conduct clinical trials, and transfer scientific expertise. ImmunityBio will collaborate closely with Saudi regulatory authorities and train healthcare professionals in advanced cell therapy protocols, supporting national objectives in biotechnology leadership.
Clinical Implementation and Research Hub
His Excellency Dr. Bandar Al Knawy, CEO of the Ministry of National Guard Health Affairs and Chairman of KAIMRC, emphasized the partnership's focus on innovation: "This partnership underscores our unwavering commitment to innovation in patient-centered care. With the adoption of CAR-NK and advancements in nanotechnology, we are not only enhancing the immune system during cancer treatment but also redefining the possibilities in healthcare. Through strategic partnerships, we aim to transform lives and elevate health outcomes throughout the MENA region."
His Excellency Dr. Majid AlFayyadh, CEO of KFSHRC, noted the alignment with their mission: "This partnership is aligned with our mission to deliver cutting-edge care and translate scientific innovation into life-saving treatment for our patients."
Together, the partners will assess integration of the BioShield platform across clinical ecosystems and jointly establish a training and research hub to serve as a regional nucleus for immune-restorative therapies.
FDA-Approved Foundation
ANKTIVA was approved by the FDA in 2024 for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. As of May 2025, Anktiva plus BCG Vaccine is available at various clinical sites in the U.S.
The announcement was made during the Saudi-U.S. Investment Forum 2025 in Riyadh, held alongside the state visit of U.S. President Donald Trump, which convened senior government officials, Fortune 500 executives, and global innovators to strengthen strategic ties and accelerate investments in sectors such as biotechnology, healthcare, clean energy, and AI.