Full Press Release Details
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
CULVER CITY, Calif., December 20, 2021 - ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, has
successfully raised an aggregate $470 million of equity and debt financing in 2021, with $300 million in new debt financing from Nant Capital, LLC. With this new financing from ImmunityBio s founder, Executive Chairman and Global
Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, on December 17, 2021, the company is now well positioned to pursue its late-stage clinical portfolio, expand large-scale GMP manufacturing capacity, and advance recruitment of
a commercial organization in the urology market.
In just a short nine months since the formation of ImmunityBio following the merger with NantKwest
in March 2021, the progress made in advancing the late-stage clinical platforms in cancer and infectious diseases has been quite remarkable, said Soon-Shiong. In less than one year, the company has accomplished several important
milestones: advanced our Universal Boost COVID T-Cell Vaccine to Phase 3; acquired, developed, and scaled multiple vaccine platforms including DNA to RNA to Subunit proteins; expanded our GMP manufacturing
capacity across NK cells, fusion proteins, and RNA vaccines; advanced clinical trial enrollment across pancreatic, breast, and bladder cancers; was selected by the NCI and national cooperative groups for a large
Lung-MAP trial; advanced our HIV clinical program globally; and received issuance of seminal cancer vaccine and bladder cancer patents with terms up to 2038.
With $470 million of financing achieved since the merger, we now have the resources to rapidly advance our late-stage pipeline, build upon our
400,000 sq. feet of GMP biologic, vaccine, and NK manufacturing facilities for 2022 and expand our commercial operations in anticipation of our bladder cancer BLA filing in Q1, 2022, continued Soon-Shiong. I am proud of the tireless
efforts of management and of the entire organization who dedicated their efforts to accomplish these ambitious milestones and I am pleased to support the recently completed financing round.
ImmunityBio now has 21 active clinical trials, 13 of which are in Phase II or III development. In addition,
the company has held discussions with the FDA to file a biologics license application (BLA) for AnktivaTM (to be branded VesAnktivaTM for intravesical administration) plus BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS)
with a planned data cutoff date of January 2022, under discussions with the FDA. By that date, the median follow-up of patients with high risk CIS BCG responsive disease will exceed 24 months.
ImmunityBio and its scientists published over twenty scientific papers on its immunotherapy portfolio in 2021 and the company has over 750 granted patents for
its immunotherapy technologies, including the Nant Cancer Vaccine.
During the year, management and the clinical, regulatory, scientific, and
manufacturing teams made tremendous progress across the board at ImmunityBio. We are advancing our clinical development at an increasing rate with the goal of positioning ourselves to apply for regulatory approval in 2022, said Richard Adcock,
President and CEO of ImmunityBio. With the $300 million financing from Nant Capital combined with the equity raised over the last nine months, we have made the decision to pause the At-the-Market offering and we are well positioned to further accelerate development of our oncology and COVID-19 trials with the goal of bringing these promising
technologies to more people in need globally.
Clinical Year-End Review of Strategic Milestones:
The company reported that the primary end points were met for both CIS and Papillary BCG-unresponsive non-muscle invasive bladder cancer in October 2021 with a complete remission rate of 72% and a 12-month
disease-free rate of 57%, respectively.
At the end of November 2021, the company provided briefing books and updates to the FDA with November cutoff data
showing a 72% complete response rate in the CIS cohort and a median duration of complete response of 24 months. Of note, in those patients who responded to the investigational therapeutic, the probability of avoiding both progression of bladder
cancer and cystectomy for over 24 months exceeded 90 percent. The data to the FDA included findings that the combination of Anktiva and BCG had a high safety profile with zero percent treatment-related serious adverse events, zero percent
immune related adverse events, and 100 percent bladder cancer-specific overall survival at 24 months. The company plans on a data cutoff in January 2022, which would provide a median follow up in this CIS cohort in excess of 24 months, and
anticipates a BLA filing with this final analysis in Q1, 2022.
The papillary cohort continues to accrue and updates will be provided as part of an oral
presentation at the ASCO Genitourinary Cancers Symposium in February 2022.
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.
In October 2021, ImmunityBio announced that the study s third cohort, which includes patients with third-line or greater disease, is fully enrolled
and of the evaluable patients, 90% (43/48) have exceeded the historical survival rates of approximately two months with standard-of-care chemotherapy. Based on the
strength of this early data and the significant unmet medical need, ImmunityBio submitted an amendment to the FDA to increase enrollment in the third cohort ( Cohort C ), and enrollment is actively ongoing. The interim results of Cohort C
in the QUILT 88 study have been selected for presentation at the ASCO Gastrointestinal Cancers Symposium, January 2022 in San Francisco and the data to date continues to show that the historical overall survival in patients who have enrolled with
3rd, 4th, 5th and even 6th line metastatic pancreatic cancer exceeds any historical overall survival rate for this advanced stage of disease for which there is no further treatment options available.
ImmunityBio s study will test
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 the Institutional 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.
Both studies have opened and patients are actively enrolling. Preliminary data will be reported in 2022.
Since the inception of the pandemic, ImmunityBio and its scientists have hypothesized that antibody-based vaccines alone are insufficient
to prevent transmission and will not overcome viral evolution, resulting in loss of efficacy of antibody-based vaccines with the inevitable development of variants. The company from the onset believed strongly that an immune response generating
a combination of antibodies, T cells, and memory B cells is critical to prevent infection, reduce viral load, prevent transmission, provide durable protection and overcome this 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 ImmunityBio in September 2020, supported by
BARDA confirmed that ImmunityBio s second-generation hAd5 S+N vaccine accomplished the goal of reducing viral load following a COVID virus challenge, to non-detectable levels. The study was published on
September 2021 in Frontiers in Immunology entitled, Dual-Antigen COVID-19 Vaccine Subcutaneous Prime Delivery with Oral Boosts Protects NHP Against SARS-CoV-2 Challenge , showing the presence of memory B cells and a rapid antibody response post-challenge with killing of infected cells resulting in no detectable COVID viruses in the nasal and
On the basis of these findings, the ImmunityBio program was designed to pursue this strategy of driving T cell and
antibody protection, and to develop a second-generation vaccine with broad depth of antigenic coverage. Furthermore, the company pursued a strategy to develop a vaccine that could be manufactured at scale, at low cost, overcome cold-chain
distribution issues and provide long-lasting durable protection for the global population. The programs, initiated as early as March 2020, are described below and the initial findings have shown that hAd5 S+N vaccination as a single prime alone
induces a 10-fold increase in mean T cell responses in Phase 1 participants and are sustained against spike variants.
Since initiating the initial homologous prime boost trial in October 2020 in the United States, it has become apparent that a
mix-and-match strategy could provide maximal immune protection. The company has followed this path and the homologous and heterologous portfolio of vaccine platforms are at various stages of clinical development.
Homologous hAd5 S + N Platform Prime & Boost:
In October 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. In February 2021, this trial was expanded to South Africa (The ProVIVA-SA1 Trial).
To date, 74 participants have enrolled in the U.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 in South Africa in July 2021.
United States Studies: In April 2021, we reported on the preliminary data from the
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 that ImmunityBio provide multiple risk mitigations and management
measures, which ImmunityBio did and incorporated into all new COVID-19 study protocols, lifting all clinical holds. The immunogenicity assays from the U.S. trials are being validated and this process is
expected to be completed in Q1 2022. The ongoing U.S. trials will be completed as planned with the subjects who have been enrolled.
ImmunityBio has acquired the rights to multiple platforms and initiated a consortium including the Baylor College of Medicine, Infectious
Disease Research Institute (IDRI), Amyris, Inc. and EnGeneIC 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 in April 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 the Baylor 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 in South Africa and Botswana 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 in November
2021, expansion of its vaccine program.
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 affecting South Africa and other countries. Phase 1 studies of subcutaneous
dosing in the U.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 in January 2022.
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 in South Africa.
SASA RNA Prime + Nabisome EDV or RBD Subunit Protein Boost
Nabisome (EDV) Platform: In November 2021, EnGeneIC and ImmunityBio 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 in Australia. 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 in Australia and the U.S. and use Nabisome in
combination with SASA RNA in the PULA trial in Botswana. The PULA Mix-and-Match Trial will be submitted in Q4 2021 for regulatory review.
RBD Recombinant Protein Subunit + Adjuvant Platform: In November 2021, ImmunityBio announced it had licensed a recombinant protein COVID-19
vaccine (RBD Subunit) candidate from Baylor College of Medicine, which was developed at the Texas Children s Hospital Center for Vaccine Development. Protein-based vaccines have long been used to confer immunity against hepatitis B and human