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.
A Smarter Treatment
Accessibility Facilitated by Outpatient DeliveryPatients receive our NK cells in the outpatient setting—hospitalization is not required. Because community-based healthcare delivery facilities are available to the vast majority of patients throughout the country, this treatment is 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 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 PotencyOur 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.
Predicted to be safeThe ImmunityBio cell therapy platforms have been well tolerated, with a favorable preliminary safety profile. Our engineered natural killer cells 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 SystemUnlike 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 AvailableOur 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.
Investigational Therapies for Difficult Diseases
We are conducting a Phase II, open-label, randomized, three-cohort comparative study of our PD-L1 t-haNK natural killer cell product with ImmunityBio’s proprietary IL-15 superagonist Anktiva (N-803) and aldoxorubicin in combination with standard-of-care therapy, versus standard-of-care therapy alone for front-line maintenance, and second-line or greater treatment for locally-advanced or metastatic pancreatic cancer. All three study cohorts of the trial are open and actively enrolling patients at multiple centers across the U.S. (Trial name: QUILT 88)
Merkel Cell Carcinoma
We are conducting a Phase II, open-label, single-arm trial to evaluate the novel triple combination of our “off-the-shelf” investigational CD16-targeted natural killer cell therapy (haNK) with ImmunityBio’s proprietary IL-15 superagonist Anktiva (N-803) and avelumab (without chemotherapy) in subjects that have progressed after treatment with a checkpoint inhibitor for Merkel cell carcinoma. This trial is actively recruiting patients at multiple centers across the U.S. (Trial Name: QUILT 3.063)
Non-Small Cell Lung Cancer
We are conducting a Phase IIb, open-label, multi-cohort study of combination immunotherapy in patients with non-small cell lung cancer, or 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 ImmunityBio’s proprietary IL-15 superagonist Anktiva (N-803). This trial is actively recruiting patients at multiple centers across the U.S. (Trial name: QUILT 3.055)
Triple-Negative Breast Cancer
We recently concluded a Phase II, open-label, single-arm trial to evaluate the novel triple combination of our “off-the-shelf” CD16-targeted investigational natural killer cell therapy (haNK) with ImmunityBio’s proprietary IL-15 superagonist Anktiva (N-803) and avelumab following a tumor- conditioning regimen in subjects that have progressed on or after standard-of-care therapy for triple-negative breast cancer. Based on results from this trial, we plan to conduct an open label, randomized controlled phase II trial of PD-L1 t-haNK and N-803 in combination with standard-of-care therapy versus standard-of-care therapy alone in patients with third-line TNBC. This trial will begin enrolling patients in 2021.
We are conducting a Phase II/III, multicenter trial to evaluate the novel combination of our proprietary IL-15 superagonist Anktiva plus Bacillus Calmette-Guerin (BCG), a vaccine used against tuberculosis and for treating bladder tumors or bladder cancer, in patients with BCG unresponsive high-grade non-muscle invasive bladder cancer. The FDA had granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met. (Trial name: QUILT-3.032)
We are developing a protocol to treat recurrent glioblastoma using aldoxorubicin and our proprietary IL-15 superagonist Anktiva. Unlike doxorubicin, aldoxorubicin appears to penetrate the blood-brain barrier in humans and is associated with objective tumor responses, stable disease and prolonged survival.
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.
One Vaccine, Three Trials, Three Routes of Immune Protection
We are conducting three trials to evaluate the safety, reactogenicity, and immunogenicity of the combination of our T-cell hAd5 vaccine administered orally, sublingually (under the tongue) and subcutaneously (injection) to select an optimal combination dose for future studies. A Phase I trial has also been initiated in Cape Town, South Africa to assess the safety, reactogenicity, and immunogenicity of the T-cell hAd5 vaccine and select a dose for future studies. Trials using sublingual delivery and room temperature-stable oral capsules are anticipated to follow. (Trial numbers: NCT04591717, NCT04732468, NCT04710303)
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