ImmunityBio's Stock Surge: A Closer Look at the Biotech Giant's Recent Success

ImmunityBio, Inc. (IBRX) has been making waves in the biotechnology sector, with its stock price surging by up to 20% in a single day. This significant intraday rise marks the most substantial increase since October 28. The company's announcement of substantial progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) has fueled investor confidence.

ImmunityBio is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its innovative treatment targeting Bacillus Calmette-Guérin (BCG) unresponsive NMIBC in the papillary indication. This submission is based on positive top-line results from a Phase 3 trial, which met its primary endpoint with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months. Additionally, patients receiving ANKTIVA® + BCG achieved a 93% avoidance of cystectomy with a median follow-up of 20.7 months. This immunotherapy of rescuing BCG with ANKTIVA represents a step towards providing therapeutic options in patients with BCG unresponsive NMIBC in papillary disease who currently have limited treatment choices and face radical total cystectomy.

In collaboration with the Serum Institute of India, ImmunityBio plans a regulatory submission for an alternative source of BCG in the first quarter of 2025. This initiative aims to address the shortage of BCG, ensuring a reliable supply for patients in need. The company's commitment to addressing critical supply issues and expanding the opportunity for patients and physicians to have access to high-quality and quantities of BCG to initialize and maintain treatments for bladder cancer is evident in this partnership.

ImmunityBio is also planning a Biologics License Application (BLA) in 2025 for second- and third-line treatment of patients with NSCLC, who are progressing on checkpoint inhibitors. A Phase 2b study (QUILT-3.055) demonstrated prolonged overall survival when ANKTIVA was combined with the same checkpoint inhibitors on which patients were progressing, validating the rescue potential of ANKTIVA for T cells and checkpoint inhibitors. Compared to the most frequently used chemotherapy docetaxel in this setting, ANKTIVA plus a checkpoint inhibitor represents an immunotherapeutic advance for this disease.



The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.



ImmunityBio's pipeline of immunotherapies and vaccines contributes significantly to its long-term growth potential. The company's diverse indications, platform technology, global market access, and clinical trial success all play a crucial role in driving the company's future performance. By targeting various indications, leveraging its platform technology, and pursuing global market access, ImmunityBio is well-positioned to capitalize on the growing demand for innovative therapies and vaccines.

In conclusion, ImmunityBio's stock surge can be attributed to its significant progress in clinical trials and regulatory submissions, as well as its commitment to addressing critical supply issues and expanding access to high-quality BCG for patients. The company's diverse pipeline of immunotherapies and vaccines, combined with its platform technology and global market access strategy, positions ImmunityBio for long-term growth and success in the biotechnology sector. As investors continue to monitor the company's progress, the potential for further stock price increases remains a possibility.