ImmunityBio Reports Productive Regulatory Engagement with Saudi Food and Drug Authority at USA-Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia
ImmunityBio, Inc. a commercial stage immunotherapy company developing next generation therapies that drive immunological memory and restore immune competence, today announced that the Company held productive regulatory discussions with the Saudi Food and Drug Authority (SFDA) in Riyadh, convened under the Saudi-USA Biotech Alliance hosted by the Ministry of Investment of Saudi Arabia (MISA).
The engagement advanced two regulatory priorities: (1) SFDA encouraged the Company to submit a regulatory package for its recombinant BCG (rBCG) to expand BCG access in Saudi Arabia and address the ongoing global BCG shortage, and (2) ImmunityBio and SFDA initiated discussions regarding the expansion of ANKTIVA® (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPIs) to additional tumor types in the CPI relapsed population.
Recombinant BCG: SFDA Encouragement and Planned Submission
During the meeting, the SFDA encouraged ImmunityBio to submit a regulatory package for rBCG to support access to a new source of BCG in the Kingdom and help address the global BCG shortage that has affected bladder cancer patients worldwide including the Middle East. The Company expects to submit the complete regulatory package to the SFDA within the coming weeks.
ImmunityBio’s rBCG is manufactured by the Serum Institute of India, the world’s largest vaccine manufacturer by number of doses produced, under an exclusive global licensing and supply arrangement announced in May 2024. The Serum Institute’s manufacturing facility in Pune, India, has been inspected and certified by multiple global regulatory authorities, including the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). This established regulatory pedigree provides a foundation for the SFDA’s review of the manufacturing and quality data contained in the submission dossier.
In the United States, the FDA has authorized an Expanded Access Program for rBCG to address the ongoing national shortage of TICE® BCG. The program is now active at 57 urology centers across the country, with over 500 patients enrolled and thousands of doses of rBCG administered to date. Phase 1/2 clinical trials conducted in Europe, rBCG demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and an improved safety profile compared to standard BCG, with fewer adverse events compared to earlier formulations.
ANKTIVA Plus Checkpoint Inhibitors in Patients with Multiple Tumor Types who Failed Keytruda (Pembrolizumab)
ImmunityBio and the SFDA initiated discussions for the expansion of ANKTIVA plus CPI into multiple tumor types in patients who have relapsed following checkpoint inhibitor therapy. These discussions build on the accelerated approval granted by the SFDA in January 2026 for ANKTIVA in combination with immune checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard of care therapy including checkpoint inhibitors, the first approval of this indication anywhere in the world and the first approval for subcutaneous administration of ANKTIVA plus a checkpoint inhibitor.
ImmunityBio holds multiple issued patents covering the ANKTIVA plus checkpoint inhibitor combination, including U.S. Patent Nos. 11,071,774 (NANT Cancer Vaccine) and 9,925,247 B2 (IL-15 based molecules and methods of use in combination with checkpoint inhibitors), providing intellectual property protection with terms extending beyond 2035.
The scientific rationale for expanding into additional tumor types in the CPI relapsed population is supported by data from the QUILT-3.055 Phase 2b basket trial (N=147), which enrolled patients across multiple tumor types, including NSCLC, urothelial, head and neck, melanoma, renal, gastric, and cervical cancers, who had progressed on prior checkpoint inhibitor therapy. In the NSCLC cohort (N=86), the addition of ANKTIVA to the same checkpoint inhibitor on which patients had progressed demonstrated a median overall survival of 14.1 months (95% CI 11.7, 17.4), with 12 month and 18 month survival rates of 57% and 34%, respectively. These results were observed independent of PD-L1 tumor status and independent of line of therapy.
“The SFDA’s encouragement to submit our recombinant BCG dossier, together with the initiation of discussions to expand ANKTIVA plus checkpoint inhibitors across additional tumor types, reflects the deepening regulatory relationship between ImmunityBio and the Kingdom of Saudi Arabia,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Saudi Arabia was the first country in the world to grant approval for ANKTIVA in metastatic lung cancer.
The QUILT-3.055 basket trial provides data that ANKTIVA rescues checkpoint activity across multiple tumor types, and we look forward to working with the SFDA to extend this approach to additional malignancies. In parallel, our exclusive global arrangement with the Serum Institute of India, whose manufacturing facilities have been certified by the WHO and European regulatory authorities, positions us to address the critical BCG shortage affecting patients in Saudi Arabia and globally.”
Tumor resistance to checkpoint therapy occurs when T cells are unable to recognize tumor cell antigens due to MHC-I downregulation. ANKTIVA, as an IL-15 superagonist, activates natural killer (NK) cells that can overcome this resistance, restoring the activity of checkpoint inhibitor therapy regardless of tumor type or location. The QUILT-3.055 data across multiple tumor types supports the hypothesis that NK cell activation through IL-15 stimulation can rescue checkpoint activity broadly, forming the basis for the initiated discussions with the SFDA regarding expanded tumor type indications in the Kingdom.
“The Kingdom of Saudi Arabia continues to demonstrate regulatory leadership in advancing access to innovative immunotherapies,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. “With two approved indications for ANKTIVA, a clear pathway for rBCG to address the BCG shortage, and discussions now initiated regarding additional tumor types, Saudi Arabia is becoming a critical market for ImmunityBio’s portfolio. The Saudi-USA Biotech Alliance, hosted by MISA, provides an important framework for accelerating these regulatory and commercial milestones, and we are committed to investing in our regional presence to support physicians and patients across the Middle East.”
Strategic Context
This regulatory engagement builds on ImmunityBio’s growing presence in the Kingdom of Saudi Arabia. The SFDA has granted accelerated approvals for ANKTIVA in two indications: BCG unresponsive non muscle invasive bladder cancer carcinoma in situ and metastatic NSCLC in combination with checkpoint inhibitors. The Saudi-USA Biotech Alliance, launched with the inaugural summit held in conjunction with the 44th Annual J.P. Morgan Healthcare Conference in January 2026 and hosted by MISA, reflects a broader bilateral commitment to accelerating the development, manufacturing, and deployment of next generation immunotherapies. ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia to support physicians and health systems across the Middle East and North Africa.
To support the execution of its regional strategy, ImmunityBio has established a wholly owned subsidiary in the Kingdom of Saudi Arabia, providing direct operational infrastructure to advance regulatory submissions, commercial launch activities, and clinical development across the Middle East and North Africa.
About ImmunityBio
ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”
ImmunityBio has a comprehensive immunotherapy pipeline with more than 40 clinical trials (company sponsored or investigator initiated)—of which 25 are at Phase II and III stage of development—across 19 indications in solid and liquid cancers and infectious diseases. Currently 17 first-in-human immunotherapy agents are in clinical testing and, to date, over 1,800 patients have been studied with our antibody cytokine fusion proteins, albumin chemo immunomodulators, Adeno and yeast vaccines and our off-the-shelf natural killer cell products.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).
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