ImmunityBio Expands Trials of T-Cell-Based COVID-19 Vaccine Candidate as a ‘Universal Boost’ in Vaccinated Subjects and Receives Approval to Test Intranasal Spray in South Africa

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced two South African studies to examine the potential for using its hAd5 T-cell-based COVID-19 vaccine candidate to provide extended protection for subjects with prior COVID-19 vaccinations or infections. One trial will study the use of ImmunityBio’s hAd5 candidate as a “Universal Boost” for healthcare workers previously vaccinated with a currently available spike-only antibody-based vaccine. The other will study the safety and effectiveness of the vaccine candidate intranasally in previously infected subjects.

The multiple administration methods for the vaccine candidate offer the potential for protecting patients with a single jab followed by a nasal spray. The nasal spray and oral capsule routes also have the potential to provide mucosal immunity, which could reduce both the chance of infection and the potential spread of the virus via the respiratory tract.

“The COVID-19 pandemic continues to be a major public health crisis in South Africa and in other parts of the world. It requires new solutions,” said Glenda Gray, M.D., President and CEO of the South African Medical Research Council. “Providing people with long-term immunity is vital as is making it easier for people to become vaccinated in circumstances where jabs are difficult to administer. These new trials will provide important data on a potential path forward to dealing with this crisis.”

“We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in the U.S., which show that just a single prime subcutaneous vaccination of our COVID-19 vaccine candidate induces a 10-fold increase in T cell response—equivalent to T cell responses from patients previously infected with SARS-CoV-2,” said Leonard Sender, M.D., Chief Operating Officer of ImmunityBio.

“The pre-clinical finding that our COVID-19 vaccine candidate administered via a jab and a nasal spray has the potential to provide the same level of immune protection from SARS-CoV-2 as a prime plus boost has important implications for vaccination efforts in rural and disadvantaged communities and countries,” said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. “Reducing the frequency of vaccine boosts and simplifying the distribution and administration of vaccines is critical to ending the COVID-19 pandemic globally and preventing future ones. These findings taken together with our studies in non-human primates, which showed that our COVID-19 vaccine candidate when administered as a jab followed by oral capsules conferred complete protection from a viral challenge, provide encouraging evidence that our vaccine via multiple needle-free routes could enhance its distribution and access globally.”