Culver City-based ImmunityBio’s Covid-19 vaccine candidate drug has won approval from the Food and Drug Administration to begin Phase 1 clinical trial testing, the company announced Oct. 15.
Patrick Soon-Shiong (photo by Ringo H.W. Chiu)
ImmunityBio has been developing the human adenovirus drug, known as hAd5-Covid-19, in conjunction with Culver City-based NantKwest Inc. Both companies are part of billionaire Patrick Soon-Shiong’s NantWorks family of companies. Soon-Shiong is the chief executive of each company.
With FDA approval in hand, ImmunityBio said it will recruit 35 patients for the trial, which is set to begin at Hoag Hospital’s Irvine facility by the end of the month.
According to the ImmunityBio announcement, the vaccine candidate targets both the inner nucleic acid protein and outer spike protein within the coronavirus that causes the Covid-19 disease. The drug is engineered to activate antibodies against the coronavirus. By targeting both sites within the coronavirus, the company claims the vaccine candidate provides recipients with “durable, long-term cell-mediated immunity with potent antibody stimulation” against both sets of proteins.
“While there are a number of vaccine candidates in development, we believe most are limited by their sole focus on antibody responses to the monovalent spike protein, which may be insufficient to activate the full potential of the immune system to fight the coronavirus,” Soon-Shiong said in the announcement. “By targeting the nucleocapsid protein on the interior of the virus particle as well as the spike protein on the virus’ surface, we believe this vaccine can stimulate both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2,” he added.
If this trial and subsequent Phase 2 and 3 clinical trials prove successful, ImmunityBio plans to administer the hAd5-Covid-19 vaccine to patients in two doses: a “prime” dose and a “boost” dose. The company said it is also pursuing preclinical development for oral, inhalable and nasal delivery modes for the drug.
NantKwest shares rose 6.3% on Oct. 15 to close at $9.62. ImmunityBio is privately held.
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