Clinical-stage, natural killer cell-based therapeutics company, NantKwest and ImmunityBio, a privately-held immunotherapy company announced ImmunityBio has been selected to participate in Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Efforts will focus on the development, testing, and large-scale manufacturing of ImmunityBio’s COVID-19 human adenovirus vaccine (hAd5) candidate. This is the first vaccine designed to deliver both Spike (S) and Nucleocapsid (N) DNA, offering the potential for patients to develop long-lasting immunity to the virus.
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 National Cancer Institute have demonstrated that this novel Ad5 may induce antigen-specific T-cell immunity in patients, even in the presence of pre-existing adenoviral immunity.
The companies also announced that the U.S. Food and Drug Administration (FDA) has authorized the use of ImmunityBio’s IL-15 (generic name nogapendekin alfa inbakicept) to treat patients prior to the onset of severe disease by potentially activating natural killer cells to mitigate viral replication. On May 18, NantKwest announced FDA authorization to study the use of mesenchymal stem cell treatments to modulate the immune system’s excessive response to COVID-19 infection, thereby potentially reducing the debilitating and sometimes fatal effects of the disease.
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 Patrick Soon-Shiong, M.D., Chairman and CEO of ImmunityBio and NantKwest. “Using our unique technologies, we are working just as furiously to develop therapeutics for people who are already infected. With this work, we hope to contain and eventually conquer the virus.”
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 Europe, or the first-generation human adenovirus in trials in China), and the first COVID-19 vaccine designed to deliver both Spike (S) and Nucleocapsid (N) DNA, which offers the potential for patients to develop long-lasting immunity to the virus.
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 NantKwest have been activated, with an expectation of delivering an Ad5 vaccine in high volumes later this year.
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