ImmunityBio SFDA regulatory engagement took center stage in Riyadh as ImmunityBio met with the Saudi Food and Drug Authority (SFDA) during the Saudi-USA Biotech Alliance meeting hosted by the Ministry of Investment of Saudi Arabia (MISA).
The discussions focused on two strategic priorities: expanding access to recombinant BCG (rBCG) to address the global BCG shortage and advancing ANKTIVA® in combination with checkpoint inhibitors for additional tumor types in checkpoint inhibitor-relapsed patients.
rBCG Submission to Address Global BCG Shortage
As part of the ImmunityBio SFDA regulatory engagement, the SFDA encouraged the company to submit a regulatory package for recombinant BCG (rBCG). This move aims to expand access to BCG in Saudi Arabia and help mitigate the global shortage affecting bladder cancer patients.
ImmunityBio expects to submit the full regulatory dossier in the coming weeks. The company manufactures rBCG through an exclusive global licensing and supply agreement with the Serum Institute of India, the world’s largest vaccine producer by volume.
The manufacturing facility in Pune has received certifications from major global regulators, including the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). Therefore, the established regulatory pedigree strengthens the submission package under review by the SFDA.
In the United States, the FDA has already authorized an Expanded Access Program for rBCG to address shortages of TICE® BCG. Currently, 57 urology centers participate in the program, with more than 500 patients enrolled.
ANKTIVA Plus Checkpoint Inhibitors Expansion Discussions
In addition to rBCG, the ImmunityBio SFDA regulatory engagement included discussions to expand ANKTIVA® (nogapendekin alfa inbakicept) combined with checkpoint inhibitors into additional tumor types.
Earlier in January 2026, the SFDA granted accelerated approval for ANKTIVA plus checkpoint inhibitors for adults with metastatic non-small cell lung cancer (NSCLC) who progressed after standard-of-care therapies. Notably, Saudi Arabia became the first country to approve this indication and the first to approve subcutaneous administration of the combination.
The expansion discussions build on data from the QUILT-3.055 Phase 2b basket trial. The study enrolled 147 patients across multiple tumor types, including NSCLC, urothelial, melanoma, renal, gastric, cervical, and head and neck cancers. In the NSCLC cohort, patients who received ANKTIVA alongside the same checkpoint inhibitor demonstrated a median overall survival of 14.1 months. Moreover, the 12-month and 18-month survival rates reached 57% and 34%, respectively.
Importantly, results appeared independent of PD-L1 tumor status and line of therapy, supporting broader potential applications.
Scientific Rationale and Regional Strategy
Tumor resistance to checkpoint therapy often occurs when T cells cannot recognize tumor antigens due to MHC-I downregulation. ANKTIVA, an IL-15 superagonist, activates natural killer (NK) cells. As a result, it helps restore checkpoint inhibitor activity across tumor types.
The QUILT-3.055 data supports this mechanism and forms the scientific basis for the expanded indication discussions with the SFDA.
Furthermore, Saudi Arabia continues to play a strategic role in ImmunityBio’s global expansion. The Saudi-USA Biotech Alliance, launched alongside the 44th Annual J.P. Morgan Healthcare Conference in January 2026, reflects growing bilateral collaboration in next-generation immunotherapies.
To strengthen its regional presence, ImmunityBio has established a wholly owned subsidiary in Saudi Arabia and plans to open a regional office. Consequently, the company aims to accelerate regulatory submissions, commercial launches, and clinical development across the Middle East and North Africa.
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