Investigational Therapies
for Patients

ImmunityBio has developed investigational immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate rogue or infected cells.

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A Smarter Treatment

Accessibility Facilitated by Outpatient Delivery

Many of our investigational therapeutics are administered in an outpatient setting — hospitalization is not required. Because community-based healthcare delivery facilities are available to the vast majority of patients throughout the country, our treatments are potentially more accessible to patients than those based on autologous CAR-T technology, which can only be administered at designated medical centers that are certified to competently manage potentially life-threatening side effects. Use of our NK cells, in particular is further streamlined by the universality of our NK-92 cell platform that eliminates the need for harvesting patient T-cell for the individualized therapy required by other platforms.

Engineered to Boost Innate NK Potency

Our NK cell-based platform is suitable for incorporation of chimeric antigen receptors (CARs) and antibody receptors to create higher-potency therapies and allow precise targeting. Addition of these receptors augments NK cell killing capabilities against cancers and virus-infected cells. Our ability to bioengineer and tailor NK cells significantly enhances the potential of our NK cells to successfully treat disease.

Favorable preliminary safety profile

ImmunityBio's immunotherapy and cell therapy platforms have been well tolerated, with favorable preliminary safety profiles. Our investigational therapeutics are administered in the outpatient setting and have shown no dose-limiting toxicities in patients who have received therapy. While clinical trials with CAR-T cell therapy require hospitalization and some severe adverse events have been reported, including cytokine release syndrome, no such severe toxicities have been noted to date with ImmunityBio’s natural killer cells.

Designed to Augment the Immune System

Unlike most standard cancer and infectious disease therapies that severely weaken or deplete the immune system, ImmunityBio’s approach is designed to bolster and invigorate it. Our targeted NK cell immunotherapies act as an extension to the body’s innate, fast-response immune system to outsmart disease and potentially eliminate cancerous or infected cells.

Readily Available

Our NK cells are available ‘off-the-shelf’, ready for delivery as a result of our cost-efficient and scalable manufacturing processes. We have manufactured more than three trillion cells and have multiple FDA-authorized IND applications. Our NK cells can be cryopreserved in long-term storage facilities for on-demand access from what we believe is the world’s only Good Manufacturing Practices (GMP)-compliant NK cell-line bank, a proprietary asset of our company.

Harness Nature’s First Responders™

The immune system is a biological wonder that has evolved to effectively fight many infections and diseases. Thanks to advanced research, scientists are creating new therapies that harness this natural system and enhance it to fight cancers and other diseases that can outwit the immune system. At ImmunityBio, we have developed an orchestrated “triangle offense” approach that takes advantage of the natural immune system’s power to attack and kill cancerous or virus-infected cells.

The core of our offense is our activated Natural Killer (aNK) cells. Natural NK cells, part of the innate immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. The second aspect of our triangle offense relies on the adaptive immune system, which includes specific white blood cells called ‘T cells’. T cells engage in a deeper, prolonged attack on infected or rogue cells. T cells are a kind of reserve player that have to be activated by the innate immune system. The third piece of our strategy employs chimeric antigen receptors (CARs), which are precision attackers that seek out specific and unique markers (antigens) that exist on the surface of cancer cells.

Our unique investigational PD-L1 t-haNK™ platform combines all three of these attack modes in a single cell that can be administered by a physician (investigator) in an outpatient clinic. These bioengineered NK cells are designed to directly attack rogue cells, stimulate and recruit the adaptive immune system’s cells so they learn what to attack, and home in selectively on cancer cells by use of CARs. In PD-L1 t-haNK cells, the CAR targets the ‘checkpoint’ protein programmed death domain ligand-1 (PD-L1) that can disable the immune response if not blocked. This triangle offense approach is one of the most promising therapeutic approaches for cancer treatment that has emerged in recent years, especially for patients with difficult-to-treat cancers. Checkpoint-directed and CAR-T therapies when used alone target only the adaptive, and not the innate, immune system and despite the progress in immunotherapy represented by the development of checkpoint blockers, they fail to successfully treat approximately 70% of solid tumors. Our PD-L1 t-haNK cells are distinguished from other immune-based therapies by their ability to coordinate the innate and adaptive responses that build the ‘immunological memory’ needed for robust and durable responses.

The ImmunityBio Hypothesis

The activation of the innate immune system is key to the development of immunological memory.

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Investigational Therapies for Difficult Diseases

Non-Small Cell Lung Cancer

We are conducting a phase IIb, open-label, multi-cohort study (NCT03228667) of combination immunotherapy in patients with non-small cell lung cancer (NSCLC), who have previously received treatment with immune checkpoint inhibitors. The study will evaluate our investigational PD-L1 t-haNK natural killer cell therapy with our IL-15 superagonist N-803 (ANKTIVA®). This trial is actively recruiting patients at multiple centers across the U.S. (Trial name: QUILT-3.055)

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Bladder Cancer

We are conducting a phase Ib/IIb randomized, two-cohort, open-label, multicenter study (NCT02138734) of intravesical N-803 (ANKTIVA®) plus BCG versus BCG alone, in BCG naïve patients with high-grade non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) (Trial name: QUILT-2.005). In April 2024, ANKTIVA® was approved for BCG-unresponsive NMIBC CIS with or without papillary disease.

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Glioblastoma

We are conducting a phase II open-label study (NCT06061809) to evaluate the safety and efficacy of N-803 (ANKTIVA®) and PD-L1 t-haNK when combined with Bevacizumab in patients with recurrent or progressive glioblastoma. (Trial name: QUILT-3.078)

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Lynch Syndrome

The National Cancer Institute (NCI) has opened a phase IIb clinical trial (NCT05419011) to study ImmunityBio’s investigational Tri-Ad5 vaccine combination (hAd5 CEA/MUC1/brachyury) together with ImmunityBio’s IL-15 superagonist N-803 (ANKTIVA®) in people with Lynch Syndrome to determine if the combination can prevent colorectal and other cancers in study participants.

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HIV

We are involved with two trials that are designed to study our IL-15 superagonist Anktiva in combination with other HIV therapeutics for treating, and potentially curing, patients infected with HIV.

The first trial (NCT04340596) is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and will be conducted by the AIDS Clinical Trials Group (ACTG). The Phase I trial will study Anktiva plus two bNAbs, which are broadly neutralizing HIV-1 antibodies, and enrollment is anticipated to begin in Q2 2021.

The second trial (NCT04505501) is sponsored by the Thai Red Cross AIDS Research Centre, The Henry M. Jackson Foundation for the Advancement of Military Medicine, and Walter Reed Army Institute of Research and will investigate the safety, tolerability, and immunostimulatory effects of administering Anktiva during acute HIV infection. This Phase II, 15-patient trial is expected to begin in 2021.

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Non-Hodgkin Lymphoma

We are conducting a phase I, open-label study (NCT05618925) of CD19 t-haNK as a single agent and in combination with rituximab only or with rituximab and our IL-15 superagonist N-803 (ANKTIVA®) in patients with relapsed/refractory non-Hodgkin lymphoma. (Trial name: QUILT-3.092)

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