ImmunityBio and NantKwest have dosed the first patient in phase I clinical study of a novel Covid-19 vaccine candidate called hAd5-Covid-19.
NantKwest and ImmunityBio’s hAd5-Covid-19 is a novel Covid-19 vaccine candidate designed to target the inner nucleocapsid (N) and the outer spike (S) protein, as well as activate both T cells and antibodies against the coronavirus (SARS-CoV-2).
The hAd5-COVID-19 vaccine is a second-generation human adenovirus serotype 5 vaccine that will help deliver both the spike protein and nucleocapsid protein by dual constructs of SARS-CoV-2 to potentially generate B and T cell memory to the Covid-19 antigens and long-term immunity to the virus.
The phase 1 trial is being carried out at the Hoag Hospital in Newport Beach of California. It is currently recruiting healthy adult subjects up to age 55 to assess the safety and reactogenicity of two doses of the vaccine candidate.
ImmunityBio’s novel human adenovirus vector is said to demonstrate preliminary safety in more than 125 patients in 13 phase I and II trials to date.
Both firms are currently recruiting 35 healthy adults aged between 18 years and 55 years old in the phase 1 study for the hAd5-COVID-19 vaccine candidate.
The companies will administer hAd5-COVID-19 as both a prime and boost using the same vector platform to provide sustained protection against SAR-CoV-2.
The main objective of the study is to evaluate the safety and reactogenicity of two doses of the vaccine. Both firms will also pursue development for oral, inhalational, and intranasal administration of hAd5.
In August this year, ImmunityBio and its affiliate NantKwest agreed to equally share the costs of development, manufacturing, marketing and commercialisation of the products related to Covid-19, including the hAd5 vaccine candidate.
The firms will share profits in a 60-40 ratio, and the larger share will be provided to the company that developed the product.
ImmunityBio and NantKwest chairman and CEO Dr Patrick Soon-Shiong said: “Our vaccine candidate, hdA5-COVID-19, targets both the nucleocapsid protein on the interior of the virus particle and the spike protein on the virus’ surface.
“We believe this dual targeting is a key advantage that may lead to the stimulation of both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2, which is an important differentiator from other vaccine candidates that only target the spike protein.”
Recently, ImmunityBio secured authorisation from the US Food and Drug Administration (FDA) to commence a phase I clinical study of its novel Covid-19 vaccine candidate, called hAd5-Covid-19.