- ImmunityBio’s COVID-19 vaccine candidate was selected for Operation Warp Speed, a national program to accelerate COVID-19 vaccine development. Candidate is the first human adenovirus (Ad5) vaccine designed to deliver both Spike (S) and Nucleocapsid (N) DNA for potential long-lasting humoral and cell-mediated immunity
NantKwestand ImmunityBio have signed a binding term sheet for the joint development, manufacture and marketing of vaccines and therapeutics for COVID-19
FDA authorization of 2nd generation human adenovirus (Ad5-Covid-S/N) vaccine candidate anticipated in
June 2020, trials to follow
- NantKwest GMP manufacturing plant available to produce vaccine at scale
- FDA authorized ImmunityBio’s IL-15 Investigational New Drug application for treating patients at different stages of COVID-19 infection
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This novel, E1, E2b, E3 deleted, human adenovirus vector has demonstrated safety in over 125 patients in 13 Phase 1 and 2 trials to date. Clinical studies performed by the
The companies also announced that the
To support these coordinated efforts from vaccine to therapeutics, the two companies have signed a binding term sheet to jointly develop, manufacture, and market therapeutics and vaccines for COVID-19. The binding agreement outlines how development costs will be shared, how profits will be apportioned for any successfully marketed products, and the structure of shared governance of the joint work.
“ImmunityBio is honored to have been selected as one of the 14 companies for Operation Warp Speed and is committed to moving our vaccine candidate through the process to prevent people from contracting this deadly virus,” said
Covid-19 Vaccine: Immunologically “Stealth” Ad5 platform uses E1, E2B, E3 deleted human adenovirus to deliver unique N+S COVID construct with potential for DNA transcription for months leading to long term cell-mediated immunity
ImmunityBio’s COVID-19 vaccine candidate is a novel, engineered Ad5 vaccine (as compared to the one based on the chimpanzee adenovirus currently in COVID-19 vaccine trials in
This human adenovirus platform represents an improvement over first-generation adeno-associated virus vectors, which produce large amounts of adenoviral fiber, which leads to high levels of adenoviral-neutralizing antibodies that, in turn, diminish the ability for the vaccine to be produced in the patient and thus limit ongoing immune response. In addition, the absence of the production of these adenoviral neutralizing antibodies enables this second-generation adenovirus to be administered as a prime and boost (homologous vaccination).
The vaccine is based on a human adeno virus platform, engineered to prevent the generation of adenoviral proteins with the objective that they remain “stealth” after being injected. This potentially allows long-term production of the vaccine construct in the body, even in the presence of pre-existing neutralizing antibodies. With this unique property of being “immunologically silent” in the human body, the vaccine may produce the vaccine blueprint signal for months, thus maximizing the opportunity to establish long term immunity and potential T-cell memory. This Ad5 platform has already demonstrated safety in elderly and immuno- suppressed patients in the oncology setting. Large- scale manufacturing facilities at
- ImmunityBio’s Ad5 platform is designed to be “immunologically stealth,” enabling the DNA delivered by this “quiet” adenovirus system to continuously produce its vaccine antigen for potentially over four months. This is in sharp contrast to mRNA vaccines, which can only survive a few days in-vivo.
- In multiple clinical studies in patients with advanced cancer, this second-generation Ad5 platform showed immune response even in the face of adenoviral-neutralizing antibodies. Overcoming this immune resistance made multiple re-dosing possible.
- A track record of preliminary safety of high doses (up to 15 times the anticipated COVID-19 vaccine dose) has been shown in Phase I and Phase II studies in immunosuppressed cancer patients.
- The IND has been filed with the FDA and clinical trials are anticipated to begin in June.
- Two GMP-ready manufacturing plants have been readied for COVID-19 vaccine production with capacity for 100 million doses by year-end.
COVID-19 therapeutics address the evolving stages of disease, from moderate infection to severe acute respiratory distress syndrome (SARS)
Therapeutic immunomodulators for patients with mild-to-moderate COVID-19 symptoms:
- ImmunityBio’s N-803: Interleukin 15 (IL-15) ‘superagonist’ cytokine (Nogapendekin alfa inbakicept) to stimulate natural killer cells and CD8+ T-cells; FDA IND authorization received (NCT 04385849).
- Highly selective Interleukin 15 ‘superagonist’ N-803, which has higher activity and is longer lasting than native IL-15, and has the potential to overcome low natural killer cell and T-cell count in patients with COVID-19 infections.
- A randomized, blind, placebo-controlled Phase 1b trial will assess N-803’s safety and immunostimulatory activity in COVID-19. Thirty subjects who have tested positive for SARS-CoV-2 and have confirmed mild-to-moderate COVID-19 symptoms will be enrolled.
Phase 1 trials expected to begin in
Los Angelesarea hospitals in June 2020.
- NantKwest’s haNK: CD-16, off-the-shelf natural killer cells to enhance antibody killing of infected cells, given alone or combined with Convalescent Plasma (CP); Pre-IND has been submitted to the FDA.
Therapeutic for severe and critically ill COVID-19 patients on ventilator support:
- NantKwest’s MSCs: Bone marrow-derived mesenchymal stem cells (MSC) to mitigate ‘cytopathic storm’; FDA authorization received (IND 019735).
May 18, 2020, the Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease requiring ventilator support. The therapeutic will be administered to 45 patients in critical care or an ICU setting. The primary objectives of the study include overall safety, and reduced time on a ventilator. The secondary objective is the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.
Trials to begin in early
June 2020in the Los Angelesarea.
“While we urgently research vaccines for COVID-19, we need to find effective therapeutics for treating all stages of the infection, which places divergent pressures on the immune system at different stages,” said
Agreement to Jointly Develop, Manufacture and Market COVID-19 Therapeutics and Vaccine
Under the terms of the agreement, the parties will share equally in all costs relating to developing, manufacturing, and marketing of the product candidates globally, and the global net profits from the collaboration products will be shared 60%/40% in favor of the party contributing the product on which the sales are based. All net profits from sales of combined collaboration products will be shared equally. This collaboration will be supervised by joint committees, comprised of an equal number of representatives from both companies.
haNK is a registered trademark of
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are described in detail in its
ImmunityBio’s first-in-human platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, activating both the innate (natural killer cell) and adaptive immune systems. The product pipeline includes an albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15 cytokine superagonist (N-803), checkpoint inhibitors, macrophage polarizing peptides, bi-specific fusion proteins targeting TGFb and IL-12, adenovirus, and yeast vaccine therapies targeting tumor-associated antigens and neoepitopes.
ImmunityBio’s goal is to develop therapies, including vaccines, for the prevention and treatment of cancer, HIV, influenza, and the coronavirus SARS-CoV-2.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities and clinical trials.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.