On January 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX) reported the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, ImmunityBio, JAN 15, 2025, View Source [SID1234649738]).
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The EMA covers 27 countries in the EU, as well as Iceland, Norway, and Liechtenstein. The assessment is expected to be complete by the fourth quarter of 2025. Similarly, the UK assessment of the MAA is anticipated to be completed by the fourth quarter of 2025. ImmunityBio is in continued dialog for requests for information from the two agencies, with the potential of approval by 2026.
"The submission of our applications to EMA and MHRA represents a significant milestone in our efforts to address this critical need and improve patient outcomes globally," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.
ImmunityBio continues to make strides in its mission to provide innovative therapies for patients with limited treatment options. The U.S. launch of ANKTIVA for NMIBC CIS has gained momentum, with the product now widely accessible through commercial and government insurance programs. The company recently announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9028) assigned by the Centers for Medicare & Medicaid Services (CMS) in the United States for ANKTIVA (nogapendekin alfa inbakicept-pmln) under J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram). To date, commercial and governmental insurance cover over 240 million lives for ANKTIVA.
About ANKTIVA
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. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.