The Covid-19 vaccine candidate being developed by two of billionaire Patrick Soon-Shiong’s companies moved a step closer to deployment last month as the Food and Drug Administration approved expansion of their Phase 1 clinical trial.

Culver City-based ImmunityBio Inc. and frequent partner company NantKwest Inc. of El Segundo have been developing a Covid vaccine using T-cell immunotherapy.
 
The idea is to stimulate the body’s immunity cells, known as T-cells, to remember antigens associated with the coronavirus, thereby triggering the body’s immune response. The vaccine targets the coronavirus surface spike proteins and proteins inside the virus nucleus.

ImmunityBio launched a clinical trial of this vaccine candidate last fall, using Hoag Hospital in Newport Beach as the principal trial site.

Both ImmunityBio and NantKwest are part of Soon-Shiong’s NantWorks family of companies. ImmunityBio has researched and developed the vaccine candidate while NantKwest has used its T-cell technology to manufacture the vaccine candidate.

The companies petitioned the FDA late last year to expand the clinical study to add two new delivery methods to the standard injection shot: an oral capsule that is swallowed, and tablets that are placed under the patient’s tongue and dissolve.
 
These new formulations, which the companies said had been successfully tested on primates, can be stored at room temperature.

The companies jointly announced Feb. 11 that the FDA granted their petition and that an additional 105 clinical trial participants would be enrolled by the end of this month.

Soon-Shiong in the announcement said these new formulations would help in the fight against Covid in three ways: broadening a vaccine’s reach beyond the surface spike proteins of the coronavirus into its nucleus, directly impacting the upper respiratory trhealthact where the virus typically enters the body, and reducing the need for costly and complicated refrigeration of vaccine drugs.
 
“We believe that the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to create a vaccine that activates not only antibodies but also memory B- and T-cells to multiple antigens,” Soon-Shiong said in the announcement.
 
“Furthermore, room-temperature stable formulations for oral delivery have the potential to solve the cold-chain challenges of distribution,” he added.