ImmunityBio Announces Completion of $470 Million Post-merger Financing to Fund Late-stage Cancer Clinical Trials, Phase 3 of COVID T-Cell Universal Boost Vaccine Trial and Provides Update on Bladder Cancer BLA Filing
ImmunityBio has announced the initiation of Phase 3 enrollment for the SISONKE Universal Boost COVID T-Cell vaccine trial in previously vaccinated participants in South Africa. The company has also expanded its GMP manufacturing capacity for various vaccine platforms across the U.S., South Africa, and Botswana. Significant clinical developments include a planned data cutoff for bladder cancer trials in January 2022 and a BLA filing expected in Q1 2022. ImmunityBio raised $470 million in financing in 2021 to support its clinical trials and expand operations. Key milestones include progressing 13 Phase 2/3 trials and securing pivotal patents.
- Raised $470 million in equity and debt financing in 2021, including $300 million from NantCapital.
- Initiated Phase 3 enrollment for the SISONKE Universal Boost COVID T-Cell vaccine trial.
- Met primary endpoints in bladder cancer trials with a 72% complete remission rate.
- Expansion of GMP manufacturing capacity across multiple locations to enhance production capabilities.
- 21 active clinical trials with 13 in Phase II or III development.
- Planned BLA filing for Anktiva in Q1 2022 following promising clinical data.
- None.
Year-End Review:
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SISONKE Universal Boost COVID T-Cell vaccine trial initiates Phase 3 enrollment in
South Africa in previously vaccinated participants -
Increased GMP manufacturing capacity for RNA, DNA, Subunit Proteins, and Adjuvants vaccine platforms in
U.S. ,South Africa , andBotswana -
Non-Muscle Invasive Bladder Cancer (NMIBC) planned data cutoff in
January 2022 with median follow-up exceeding 24-months for carcinoma in situ (CIS) cohort; Biologics License Application (BLA) filing planned for Q1, 2022 - Thirteen (13) Phase 2 / 3 clinical trials in progress for the treatment of multiple tumor types, COVID, and HIV
- Seminal immunotherapy patents issued with terms extended to 2038
“In just a short nine months since the formation of
“With
“During the year, management and the clinical, regulatory, scientific, and manufacturing teams made tremendous progress across the board at
Clinical Year-End Review of Strategic Milestones:
1. BCG-Unresponsive Non-Muscle Invasive Bladder Cancer CIS (QUILT 3.032)
The company reported that the primary end points were met for both CIS and Papillary BCG-unresponsive non-muscle invasive bladder cancer in
At the end of
The papillary cohort continues to accrue and updates will be provided as part of an oral presentation at the ASCO Genitourinary Cancers Symposium in
Seminal patents covering intravesical administration of BCG and Anktiva were issued (US 11,173,191 B2 and US 9,925,247 B2) providing term coverage until 2035.
2. Pancreatic Cancer (QUILT 88):
On
3. Natural Killer Cell Platform Advances
A. PD-L1 T-haNK
- Manufacturing Scale: The company has significantly advanced the manufacturing scale of PD-L1 t-haNK in 2021 and has now achieved 200-liter scale in the last nine months. At this scale, a single manufacturing campaign yields approximately 700 billion PD-L1 t-haNK cells, sufficient for 350 doses. The company has successfully manufactured and cryopreserved trillions of PD-L1 t-haNK cells and is advancing to 500-liter scale in 2022. The company believes it is the first to achieve this large-scale manufacturing capability and capacity in the field of natural killer cells.
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Clinical Trials with PD-L1 T-haNK:
- TNBC: The company continues to study this engineered NK-92 cell line in Phase 1 / 2 trials in Triple Negative Breast Cancer to increase effectiveness of Trodelvy (sacituzumab govitecn-hziy) (CT.gov NCT04927884)
- Metastatic pancreatic cancer to prolong survival rate (CT.gov NCT04390399)
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Head & Neck Cancer to increase the effectiveness of Keytruda (pembrolizumab) plus N-
803 (CT .gov NCT04847466)
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Mechanism of Action: On
March 2021 , in collaboration withNational Cancer Institute (NCI), ImmunityBio’s PD-L1 t-haNK was reported to be a potent cell therapy agent against myeloid-derived suppressor cells (MDSC) and overcome T cell escape in multiple types of resistant tumors.
B. M-ceNK
- Manufacturing Scale: The company has achieved a first-in-class manufacturing scale of highly potent natural killer cells isolated from autologous or allogeneic peripheral blood retrieved by an outpatient process of blood withdrawal and separating out white cells, termed apheresis. Over 3,000 percent M-ceNK (memory cytokine enhanced natural killer cells) cell expansion was achieved from a single apheresis. The company has successfully established proprietary proliferation and cryopreservation techniques and this first-generation manufacturing method enables as many as twenty (20) doses of 1 billion M-ceNK cells from a single apheresis. The second-generation manufacturing process has advanced the yield from 20 billion to ~100 billion M-ceNK cells, translating into ~100 doses from a single autologous or allogenic apheresis sample.
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Clinical Trials with M-ceNK in Solid Tumors: In
May 2021 , the company announced that the FDA authorizedImmunityBio to conduct a first-in-human trial to study the cryopreserved memory cytokine-enhanced NK cell (M-ceNK) platform in solid tumors. An initial study involving 20 subjects (15 healthy donors and 5 cancer patients) showed that healthy and patient-derived M-ceNK cells killed NK-resistant tumor cells with equal potency as shown in pre-clinical models. - Mechanism of Action: In an initial, proof-of-concept clinical study, memory-like NK cells with freshly isolated cytokine-stimulated NK cells demonstrated encouraging results in patients with liquid tumors. These m-ceNK cells, or memory-cytokine enriched NK cells, have been designed for autologous cell therapy, but have also been generated as an allogeneic product from cord blood. The m-ceNK product is characterized as CD56+ cells that are armed with NK cell activating surface receptors required for proliferation, homing and tumor recognition and binding. Both the healthy- and cancer patient-derived m-ceNK cells killed NK-resistant tumor cells with equal potency when tested against tumor cells of different origins, including breast, Merkel, ovarian, adenocarcinoma, and lymphoma.
C. CD-19 t-haNK
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Manufacturing Scale: Since the
June 2019 announcement of FDA authorization to launch the first engineered GMP-grade cryopreserved bi-specific NK cell therapy targeting CD-16 and CD-19 in patients with lymphoma, the merged company undertook manufacturing improvements to scale the product prior to initiation of clinical trials. These advances have been successfully completed and the amended manufacturing process has been submitted to the FDA. CD-19 T-haNK has been manufactured at 200-liter scale and the GMP product is now ready for clinical trials. - Clinical Trials: A clinical trial in advanced B cell lymphoma is anticipated to begin in the first half of 2022.
4. N-803 (Anktiva) and
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Lung Cancer : InOctober 2021 ,ImmunityBio announced that N-803 has been chosen by Lung Cancer Master Protocol (Lung-MAP), a public-private partnership—which includes theNational Cancer Institute (NCI), the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG),Friends of Cancer Research , and theFoundation for the National Institutes of Health (FNIH)—to study N-803 (Anktiva) in the Lung-MAP trial.
ImmunityBio’s study will N-803 (Anktiva) in combination with Merck’s Keytruda (pembrolizumab) in up to 478 second-line patients with tumors that are not targetable with a drug, which accounts for the majority of NSCLC cases.
In Q4 2021,ImmunityBio received approval from theInstitutional Review Board (IRB) overseeing the Lung-Map study to proceed with the trial—one of the National Cancer Institute’s largest lung cancer clinical trials with more than 700 sites. - Pancreatic Cancer, Triple Negative Breast Cancer, Head & Neck Cancer: N-803 and Aldoxorubicin are used in combination with PD-L1 t-haNK in Phase 1 / 2 clinical trials described above.
- Glioblastoma: A Phase 1 / 2 trial has been submitted for the study of N-803 and Aldoxorubicin in Glioblastoma. Further progress will be provided in 2022.
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HIV with N-803: In
June 2021 ,ImmunityBio announced the opening of a Phase 1 ‘HIV Cure Study’ in patients off therapy and a Phase 2 study in acutely infected patients. Sponsored by theNIAID and AIDS Clinical Trials Group , an “HIV cure study” will evaluate whether Anktiva (N-803) alone or together with broadly neutralizing antibodies can control HIV following interruption of antiretroviral therapy (ART). The Phase 1 open-label, randomized study will enroll 46 people living with HIV whose virus has been suppressed by ART for approximately two years, including at least 30 percent cisgender women or transgender men. A second clinical trial studying Anktiva in HIV is being conducted by theU.S. Military HIV Research Program inThailand . The Phase 2 study is evaluating Anktiva in combination with antiretroviral therapy (ART) during acute HIV infection as an experimental therapy to target and inhibit early establishment of HIV reservoirs in infected individuals.
Both studies have opened and patients are actively enrolling. Preliminary data will be reported in 2022.
5. COVID Program to Overcome Spike Variants and Induce T Cell Immunity
Since the inception of the pandemic,
In order to reduce viral load, T cells are necessary to kill virally infected cells in the nasal and lung passages and thereby prevent transmission even from highly transmissible variants. The non-human primate COVID virus challenge study performed by
On the basis of these findings, the
Since initiating the initial homologous prime boost trial in
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Homologous Platform
Homologous hAd5 S + N Platform Prime & Boost:
InOctober 2020 , the FDA authorized a Phase 1 trial of ImmunityBio’s dual construct Spike + Nucleocapsid (hAd5 S+N) COVID-19 vaccine, designed to drive both T cell and antibody immunity. The company undertook a rigorous development strategy to explore multiple methods of administration (oral, intranasal, subcutaneous, and combinations of each) to determine the best site of delivery to achieve maximum antibody, T cell and mucosal immunity. InFebruary 2021 , this trial was expanded toSouth Africa (The ProVIVA-SA1 Trial). To date, 74 participants have enrolled in theU.S. and South African Phase 1 studies. Data acquisition and analysis from both trials is ongoing. Preliminary analysis has shown that subcutaneous dosing of hAd5 S+N provides strong T cell responses to both Spike and Nucleocapsid antigens with no serious adverse events reported to date. These studies formed the basis of the Universal T Cell Boost Trial (SISONKE Boost Trial) activated inSouth Africa inJuly 2021 .
United States Studies: InApril 2021 , we reported on the preliminary data fromthe United States trial showing that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induced a 10-fold increase in T cell response—equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus. In light of the FDA Guidance to the industry regarding risks of thrombosis with thrombocytopenia syndrome (TTS) that were observed with other adenoviral vectored COVID-19 vaccines, the FDA requested thatImmunityBio provide multiple risk mitigations and management measures, whichImmunityBio did and incorporated into all new COVID-19 study protocols, lifting all clinical holds. The immunogenicity assays from theU.S. trials are being validated and this process is expected to be completed in Q1 2022. The ongoingU.S. trials will be completed as planned with the subjects who have been enrolled.
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Heterologous Mix-and-Match Program
ImmunityBio has acquired the rights to multiple platforms and initiated a consortium includingBaylor Medical College ,Infectious Disease Research Institute (IDRI), Amyris, Inc. andEnGeneIC to develop, manufacture and scale second-generation vaccines that combine different advanced DNA, RNA, protein constructs, and adjuvants. The company has adopted a long-term approach to addressing COVID and future pandemics and believes these mix-and-match components are critical to providing accessible, broad, and durable protection against current and future variants such as Delta and Omicron variants.
“Developing a novel vaccine candidate during a global pandemic has been challenging for a number of reasons, which have affected all drug developers,” said Soon-Shiong. “When we first announced our intent to develop a COVID-19 vaccine inApril 2020 , we indicated a vaccine that generates long-lasting, cell-mediated T cell immunity would require the use of genomics, molecular dynamics, and new vectors. We also hypothesized that a heterologous approach (mix-and-match) would strengthen immune response. Almost two years into the pandemic and dozens of virus mutations later, these predictions are proving more accurate than ever, which is why we are partnering with IDRI, Amyris, Inc.,EnGeneIC , and theBaylor College of Medicine to develop next generation mRNA, recombinant protein vaccine candidates and first-in-class invariant NK-T Cell (iNK-T) COVID vaccines. We anticipate being able to move quickly to enroll participants in our COVID-19 trials inSouth Africa andBotswana and, ideally, bringing a highly effective vaccine to market in the next 12-18 months.”ImmunityBio has undertaken the strategy that a mix-and-match approach of different vaccine platforms (DNA, RNA and subunit proteins) would provide the strongest durable immunity and allow large-scale manufacturing, mitigating supply chain limitations of any single platform. To execute on this strategy, the company announced inNovember 2021 , expansion of its vaccine program.
1. Heterologous SISONKE Universal Boost T Cell Trial (South Africa ):
J&J Ad26 Prime + hAd5 S + N Boost Enters Phase 3
The SISONKE Universal Boost T Cell Trial was the first DNA / DNA heterologous mix and match trial of Ad26 and hAd5. The Phase 1 / 2 / 3 trial was designed to study the efficacy, safety, and immunogenicity of ImmunityBio’s T-Cell COVID-19 vaccine as a boost in participants who have already received a spike-only antibody-based vaccine. The study is designed to explore whether the T-cell-based vaccine could prevent breakthrough infections from the Delta variant in health care workers who are already vaccinated. The goal of the hAd5 S+N vaccine is to potentially provide increased protection and long-term immunity against the multiple variants and multiple waves affectingSouth Africa and other countries. Phase 1 studies of subcutaneous dosing inU.S. have demonstrated no serious adverse events and potent T-cell responses after a single prime dose.
The SISONKE Universal Boost Phase 2 trial is fully enrolled with 60 participants with no serious adverse events. The Phase 3 trial is now open and enrollment will begin inJanuary 2022 .
2. Heterologous THEMBA Trial (South Africa ):
SASA RNA Prime + hAd5 S+N Boost
The THEMBA trial is the first heterologous RNA / DNA prime boost study of self-amplifying self-adjuvating RNA (SASA-RNA), next-generation nano-lipid carriers with hAd5 S+N. The trial is under regulatory review at SAHPRA and the company is awaiting authorization to begin the study inSouth Africa .
3. Heterologous PULA Trial (Botswana ):
SASA RNA Prime + Nabisome EDV or RBD Subunit Protein Boost
Nabisome (EDV) Platform: InNovember 2021 ,EnGeneIC andImmunityBio signed an exclusive, worldwide license agreement to develop the first invariant NK – T (iNK-T) cell vaccine for the treatment of COVID. This nano cell technology, termed Nabisome EDV, is now in Phase 1 clinical trials inAustralia . To date, the initial dose of 2x109 EDV IM dose has been shown to be safe with promising antibody, memory B cell and T-cell activity.ImmunityBio plans to expand this trial inAustralia and theU.S. and use Nabisome in combination with SASA RNA in the PULA trial inBotswana . The PULA Mix-and-Match Trial will be submitted Q4 2021 for regulatory review.
RBD Recombinant Protein Subunit + Adjuvant Platform: InNovember 2021 ,ImmunityBio announced it had licensed a recombinant protein COVID-19 vaccine (RBD Subunit) candidate fromBaylor College of Medicine , which was developed at the Texas Children’sHospital Center for Vaccine Development . Protein-based vaccines have long been used to confer immunity against hepatitis B and human papillomavirus (HPV), as immune responses often target proteins that are part of viruses and bacteria. This recombinant protein vaccine technology is proven and well-established. Production of these vaccines can be easily scaled up in low-resource countries. Paired with powerful adjuvant formulations developed by IDRI and partners, protein-based vaccines can provide broad protection against multiple coronavirus variants and are stable at room temperatures.ImmunityBio will lead development, manufacture scale up and commercialization of the recombinant protein vaccine candidate inSouth Africa .
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Vaccine Manufacturing Capacity
ImmunityBio has expanded manufacturing capacity for each of these platforms (hAd5, SASA RNA, Adjuvants, and RBD subunit) in theU.S. , as well as secured manufacturing sites inSouth Africa andBotswana with strategic collaborators. The SASA RNA manufacturing capacity will support theImmunityBio /Amyris COVID-19 joint venture.
About
ImmunityBio’s clinical pipeline consists of 21 clinical trials—13 of which are in Phase II or III development—across 12 indications in solid and liquid cancers (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Currently 17 first-in-human immunotherapy agents are in clinical testing and, to date, over 1,800 patients have been studied with our antibody cytokine fusion proteins, albumin chemo immunomodulators, Adeno and yeast vaccines and our off-the-shelf natural killer cell products. Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the
The company’s platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and state-of-the-art, off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding plans regarding ImmunityBio’s ATM offering, the timing of the filing of ImmunityBio’s BLA, timing of regulatory approval of ImmunityBio’s product candidates, additional manufacturing capacity to produce vaccines, the development of therapeutics for cancer and infectious diseases, the efficacy of the combination approach in conferring long-term immunity against COVID-19 and its variants, potential advantages of ImmunityBio’s vaccine candidates as compared to existing COVID-19 vaccines, and clinical trial enrollment and advancements, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues”, “could”, “estimates,” “expects,” “intends,” “may,” “plans,” “potential”, “predicts”, “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to
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