ImmunityBio's ANKTIVA® Application Approved by UK MHRA for BCG-unresponsive Bladder Cancer

ImmunityBio, Inc., an innovative company specializing in immune therapy, has announced a significant development in its efforts to combat bladder cancer. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has officially validated and accepted their application for marketing authorization for ANKTIVA. This step marks the beginning of the MHRA's assessment process for using ANKTIVA, also known as nogapendekin alfa inbakicept-pmln, in combination with bacillus Calmette-Guérin (BCG) for treating patients with non-muscle invasive bladder cancer that is unresponsive to BCG, specifically those with carcinoma in situ, with or without papillary tumors. The MHRA plays a crucial role in regulating medicines, medical devices, and blood components for transfusion in the UK.

This acceptance by the MHRA follows closely on the heels of the European Medicines Agency's decision to review the marketing authorization application for ANKTIVA across 30 European countries. Additionally, it comes just ten months after the U.S. Food and Drug Administration (FDA) approved the therapy. Dr. Patrick Soon-Shiong, the Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, emphasized the company's commitment to making ANKTIVA widely accessible to patients and expressed optimism about the approval process.

ANKTIVA is a pioneering therapy that harnesses the power of the cytokine interleukin-15 (IL-15), which is integral to the immune system. IL-15 influences the development and functioning of key immune cells like NK cells and CD8+ killer T cells, which are essential for targeting and destroying cancer cells. ANKTIVA acts as an IL-15 agonist IgG1 fusion complex, comprising an IL-15 mutant combined with an IL-15 receptor alpha. This combination binds effectively to IL-15 receptors on various immune cells, including NK, CD4+, and CD8+ T cells. The fusion complex mimics the natural properties of the membrane-bound IL-15 receptor alpha, facilitating IL-15 delivery through dendritic cells. This action leads to the activation and proliferation of NK cells and memory killer T cells, which retain immune memory against cancerous clones.

This proliferation and memory activation result in immunogenic cell death, establishing a balanced state with sustained complete responses. ANKTIVA boasts improved pharmacokinetics, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to non-complexed IL-15 in vivo. The FDA approved ANKTIVA in 2024 for use in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

ImmunityBio, the company behind ANKTIVA, is focused on developing next-generation therapies and vaccines that enhance the body's natural immune system to fight cancers and infectious diseases. Their immunotherapy and cell therapy platforms are designed to stimulate and sustain an immune response, aiming for long-lasting and safe protection against diseases. ANKTIVA is the first immunotherapy approved by the FDA for non-muscle invasive bladder cancer with carcinoma in situ, activating NK cells, T cells, and memory T cells for an extended response. ImmunityBio is also exploring potential cancer vaccines and developing immunotherapies and cell therapies that might reduce or eliminate the need for traditional high-dose chemotherapy. Their goal is to make these treatments more effective, accessible, and easier to administer than current standards of care in oncology and infectious diseases.

The company advises caution regarding the use of ANKTIVA, as delaying cystectomy can lead to potentially fatal muscle invasive or metastatic bladder cancer. If a patient does not exhibit a complete response after a second induction course of ANKTIVA combined with BCG, reconsidering cystectomy is recommended. ANKTIVA is intended for intravesical use only, and care must be taken to adhere to proper administration guidelines. Pregnant women should be aware of potential risks, and adverse reactions such as increased creatinine and urinary tract infections have been reported.