Shares of ImmunityBio (NASDAQ:IBRX) climbed 6% on Wednesday morning after the company said Saudi Arabia’s Food and Drug Authority had granted accelerated approval for its ANKTIVA treatment, to be used alongside checkpoint inhibitors in patients with metastatic non-small cell lung cancer.
The decision represents the first regulatory approval globally for ANKTIVA, a subcutaneously delivered IL-15 receptor superagonist aimed at reactivating the immune system. The company describes the therapy as “immunotherapy 2.0” — positioning it as the first approved chemotherapy-free immunotherapy designed to stimulate both natural killer cells and cytotoxic T cells.
Saudi regulators based the approval on evidence from two clinical studies that showed meaningful immune system recovery, as well as a link between lymphocyte restoration and improved survival in patients previously treated with checkpoint inhibitors.
“This approval represents a significant step forward for lung cancer patients in the Kingdom of Saudi Arabia and a meaningful milestone that we hope will pave the way toward additional approvals across a region where lung cancer claims far too many lives each year,” said Patrick Soon-Shiong, ImmunityBio’s Founder and Executive Chairman.
According to the Saudi Ministry of Health, lung cancer is among the most common cancers in the country, ranking third among men over the age of 45.
ImmunityBio said it plans to open a regional office in Saudi Arabia to support clinicians across the Middle East and North Africa, working with Biopharma Cigalah as its commercial distribution partner in the region.
The company is also running a confirmatory randomized trial in patients with non-small cell lung cancer whose disease has progressed following chemoradiation and checkpoint inhibitor therapy.