On April 21, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported new clinical findings for ANKTIVA (nogapendekin alfa inbakicept-pmln) in non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) and updated data on papillary disease without CIS at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29 (Press release, ImmunityBio, APR 21, 2025, View Source [SID1234651990]). The company will also host an educational and peer-networking event to discuss ImmunityBio’s approach to treatment of NMIBC CIS and papillary disease and how they have impacted patients.

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"ImmunityBio has made remarkable strides in 2025, marked by groundbreaking long-term efficacy data for ANKTIVA and the launch of our Expanded Access Program to help end the BCG shortage," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "With these critical advancements, we are eager to connect, collaborate, and drive meaningful discussions with the urology community at AUA 2025, shaping the future of bladder and prostate cancer care together. In addition, ImmunityBio has applied for Expanded Access for the use of ANKTIVA as a ‘BioShield’ in patients receiving chemotherapy, radiation, and immunotherapy to enable access to ANKTIVA across the country for patients in need."

Oral Presentations by Key Opinion Leaders:

Presented research will continue to demonstrate long-term duration of response with ANKTIVA + BCG in an updated analysis of the pivotal QUILT 3.032 trial in CIS and papillary BCG-Unresponsive NMIBC.

An Update on QUILT 3.032: Complete Responses to N-803 plus BCG Therapy in BCG-Unresponsive Bladder Carcinoma in Situ (CIS) With or Without Ta/T1 Papillary Disease (PD12-12)
Chang S. Oral Podium Presentation. Session: Bladder Cancer: Non-Invasive II, Saturday, April 26, 3:30 pm – 5:30 pm PDT, Galileo 1001, The Venetian Convention & Expo Center
Keynote Events by Dr. Soon-Shiong at AUA

Patrick Soon-Shiong, M.D., will participate in a series of presentations showcasing the power and potential of immunotherapy in shaping the future of urological cancers.

Embracing the Future: The Power of Innovation in a Changing World
Dr. Patrick Soon-Shiong, Keynote. AUA Innovation Nexus Conference, Friday, April 25, 1:00-1:45 pm PDT, The Venetian Convention & Expo Center
The Science of the Triangle Offense: NMIBC Patient and Prostate Cancer Experience
Educational and peer-networking event with Drs. Patrick Soon-Shiong, ImmunityBio Chief Medical Officer Sandeep "Bobby" Reddy, and Senior Vice President of Medical Affairs Bruce Brown, Saturday, April 26, 6:30 pm – 9:00 pm PDT, The Venetian Convention & Expo Center
The Missing Link: Overcoming Lymphopenia through NK & Memory T Cells to Achieve Durable Responses in Urological Diseases – ALC Matters, Duration Matters, the Immune System Matters
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Sunday, April 27, 1:30 pm – 2:30 pm PDT, Science & Technology Hall, The Venetian Convention & Expo Center
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 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.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.