Connecting the Dots of ANKTIVA’s Triangle Offense: A Deep Dive with Dr. Patrick Soon-Shiong and Dr. Ashish Kamat in a Three-Part UroToday Podcast
ImmunityBio (NASDAQ: IBRX) announced three podcasts with UroToday discussing the FDA approval of ANKTIVA® (N-803) plus BCG for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). Dr. Patrick Soon-Shiong and Dr. Ashish Kamat highlighted ANKTIVA’s unique mechanism, which activates NK cells, killer T cells, and memory T cells to fight tumors. They emphasized the collaboration with Serum Institute of India to address BCG shortages. ANKTIVA, an IL-15 receptor agonist, offers a new treatment option for BCG-unresponsive NMIBC patients, promoting durable complete responses by converting MHC-negative tumors to MHC-positive. The podcasts are available on UroToday's website.
- FDA approval of ANKTIVA® (N-803) plus BCG for NMIBC CIS.
- ANKTIVA activates NK cells, killer T cells, and memory T cells, enhancing the body's immune response.
- The treatment shows potential for durable complete responses in bladder cancer.
- Collaboration with Serum Institute of India to ensure BCG supply.
- ANKTIVA represents next-generation immunotherapy beyond checkpoint inhibitors.
- Potential to convert MHC-negative tumors to MHC-positive with NK cell activation.
- No financial data or revenue projections provided.
- Potential reliance on Serum Institute of India for BCG supply stability.
- information on market penetration and adoption rates for ANKTIVA.
Insights
ANKTIVA's FDA approval is a significant milestone for treating non-muscle invasive bladder cancer (NMIBC). This is particularly relevant for patients with BCG-unresponsive carcinoma in situ (CIS). Traditional BCG treatment can lead to a loss of MHC (major histocompatibility complex), allowing cancer cells to evade T-cell attacks. ANKTIVA, however, specifically targets these MHC-negative cells.
Dr. Patrick Soon-Shiong explained that ANKTIVA activates natural killer (NK) cells and both killer and memory T cells. This dual activation is unique because it offers a more comprehensive immune response. By converting 'cold' tumors to 'hot' tumors, ANKTIVA effectively makes them more visible to the immune system. This mechanism can be intuitively understood as boosting the body's natural defenses to recognize and continually attack the cancer cells.
From a clinical perspective, this treatment is a leap beyond current checkpoint inhibitors, offering new hope for NMIBC patients who previously had limited options. The importance of this FDA approval cannot be understated, as it opens the door to further research into leveraging the immune system for cancer treatment.
The partnership with the Serum Institute of India addresses a critical shortage in BCG supply. This is important because BCG is a foundational treatment for bladder cancer. The collaboration ensures that patients will have continued access to essential adjunct therapies, boosting the overall efficacy of ANKTIVA.
From a research standpoint, ANKTIVA's IL-15 receptor agonist properties are groundbreaking. The fusion of IL-15N72D with IL-15 receptor alpha enhances its stability and efficacy in lymphoid tissues. This leads to prolonged activity and a more durable response compared to traditional IL-15 therapies. ANKTIVA's ability to maintain higher activity levels in the body's immune cells without frequent dosing is a significant innovation.
Moreover, the long-lasting complete responses observed indicate a substantial improvement in patient outcomes. This treatment's implications extend beyond bladder cancer to potentially transform how intractable cancers are managed in general.
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Three-part podcast interview features
- The mechanism of action of ANKTIVA® activating NK cells, Killer T cells, and Memory T cells
- The clinical findings of a durable complete response and implications for nonmuscle invasive bladder cancer patients with the launch of ANKTIVA
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Addressing the shortage of BCG and collaboration with Serum Institute of
India
Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific at ImmunityBio, discussed the breaking news of the FDA approval of Anktiva with Ashish Kamat, M.D., MBBS, an Endowed Professor of Urologic Oncology and Cancer Research at University of Texas MD Anderson Cancer Center at the recent American Urological Association (AUA) Annual Meeting.
In a three-part interview with Dr. Kamat, Dr. Soon-Shiong provided an in-depth overview of ANKTIVA’s unique mechanism of action, the implications of this mechanism for cancer immunotherapy, supply updates, and ImmunityBio’s new partnership with the Serum Institute of
“The reports that BCG induces loss of MHC has only been recently discovered, resulting in progression of the cancer with cancer immune evasion from the T cells. These MHC-negative cells are the exact target for natural killer cells which ANKTIVA activates. The potential to convert a MHC-negative (cold) tumor to a MHC-positive (hot) tumor with NK cell activation, and restoring CD8+ killer T cells and memory T cells, may have important implications in addressing cancers that have reached this stage of escape and progression,” said Dr. Soon-Shiong.
“The approval of this treatment represents a next-generation immunotherapy beyond checkpoint inhibitors and provides a new treatment option for patients with BCG-unresponsive NMIBC,” he said.
ANKTIVA, a first-in-class IL-15 receptor agonist, received approval from the FDA on April 22 for the treatment of patients with BCG-unresponsive NMIBC CIS. ANKTIVA’s unique mechanism of action activates the body’s natural killer cells and killer T-cell immune system to attack tumor cells. It also stimulates memory T cells, leading to long-lasting complete responses.
The podcasts are available for viewing below:
Addressing BCG Supply Shortages, Workflow, and Enhancing Bladder Cancer Treatment through Strategic Partnerships - Patrick Soon-Shiong
https://www.urotoday.com/video-lectures/non-muscle-invasive-bladdercancer/video/mediaitem/4038-addressing-bcg-supply-shortages-workflow-and-enhancing-bladder-cancer-treatment-through-strategic-partnerships-patrick-soon-shiong.html
New Bladder Cancer Treatment: Mechanisms, Clinical Findings, and Implications - Patrick Soon-Shiong
https://www.urotoday.com/video-lectures/non-muscle-invasive-bladdercancer/video/mediaitem/4037-new-bladder-cancer-treatment-mechanisms-clinical-findings-and-implications-patrick-soon-shiong.html
The Triangle Offense: Harnessing NK Cells, T-Cells, and Memory Cells in Bladder Cancer - Patrick Soon-Shiong
https://www.urotoday.com/video-lectures/non-muscle-invasive-bladdercancer/video/mediaitem/4036-the-triangle-offense-harnessing-nk-cells-t-cells-and-memory-cells-in-bladder-cancer-patrick-soon-shiong.html
How ANKTIVA (N-803) Works
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.
N-803 is a novel IL-15 superagonist 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 mimics the natural biological properties of dendritic cells, and drives the generation of memory killer T cells that have specifically been trained to recognize the cancer cells, resulting in activation and proliferation of these killing cells with durable complete response. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release and the publications referred to herein contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, product availability, potential regulatory pathways and approvals, the regulatory review process and timing thereof, BCG supply shortages and related strategies, market and prevalence data, potential benefits to patients, potential treatment actions for patients, the described mechanism of action and results and contributions therefrom, information regarding ongoing pre-clinical studies and clinical trials, potential future uses and applications of ANKTIVA in additional indications and use in cancer vaccines, methods, the collaboration between ImmunityBio and the Serum Institute of
View source version on businesswire.com: https://www.businesswire.com/news/home/20240516520260/en/
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Greg Tenor
Salutem
+1 717-919-6794
Gregory.Tenor@Salutemcomms.com
Source: ImmunityBio, Inc.
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