📢 𝗝𝗨𝗦𝗧 𝗜𝗡: $ImmunityBio(IBRX.US) ImmunityBi

📢 𝗝𝗨𝗦𝗧 𝗜𝗡: $ImmunityBio(IBRX.US) ImmunityBio's ANKTIVA Wins Broad UAE Approval for Bladder and Lung Cancer

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:

➤ 𝗨𝗔𝗘 grants marketing authorization for 𝗔𝗡𝗞𝗧𝗜𝗩𝗔 across two cancer indications.

➤ Authorization expands ANKTIVA's global regulatory footprint to 𝟯𝟰 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀.

➤ UAE becomes the 𝟱𝘁𝗵 regulatory jurisdiction to approve ANKTIVA.

➤ Approval includes the broadest 𝗕𝗖𝗚-𝘂𝗻𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝘃𝗲 𝗡𝗠𝗜𝗕𝗖 label to date.

➤ First global approval covering 𝗖𝗜𝗦 with or without papillary tumors and papillary-only disease.

➤ ANKTIVA also approved for metastatic 𝗡𝗦𝗖𝗟𝗖 after checkpoint inhibitor failure.

➤ NMIBC trial achieved 𝟳𝟭% complete response rate in CIS patients.

➤ Papillary-only cohort reported 𝟱𝟴.𝟮% 12-month disease-free survival.

➤ NSCLC study reported median overall survival of 𝟭𝟰.𝟲 𝗺𝗼𝗻𝘁𝗵𝘀.

👉 𝗪𝗵𝘆 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿𝘀:

➤ Expands commercial opportunity with approvals across 𝟯𝟰 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀.

➤ Broad NMIBC label could significantly increase ANKTIVA's eligible patient population.

➤ Adds a new treatment option for patients with limited post-BCG or post-checkpoint therapies.

➤ Strengthens 𝗜𝗺𝗺𝘂𝗻𝗶𝘁𝘆𝗕𝗶𝗼's global regulatory and commercialization strategy.

👉 𝗘𝘅𝗽𝗲𝗿𝘁 𝗦𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁:

𝗣𝗮𝘁𝗿𝗶𝗰𝗸 𝗦𝗼𝗼𝗻-𝗦𝗵𝗶𝗼𝗻𝗴, 𝗠.𝗗., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio:

“For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors.”