Since the beginning of the pandemic, we have believed that a highly mutable spike (S)-only focused, antibody-based vaccine approach that could require boosters approximately every six months would prove insufficient to overcome viral evolution. We hypothesized that T-cell responses would be critical for viral clearance and long-term immunity, thus we focused on a vaccine strategy that would also include the more highly conserved SARS-CoV-2 nucleocapsid (N) protein, known to stimulate T-cell activity. Based on data from a viral challenge study of our S + N vaccine in non-human primates and early clinical trial results – and given the mass adoption of S-only vaccines – we are now assessing S- and N- based vaccines as universal T-cell booster candidates in a set of trials currently underway in South Africa.

COVID 4.015 – THEMBA self-amplifying (sa)RNA Vaccine Boost—South Africa

antibodies-can-block-infection-when-presentThe THEMBA trials, initiated in South Africa in 2022, are the first clinical studies of our joint venture AAHI-SC series saRNA vaccine technology delivered with next-generation nano-lipid carriers (NLCs). The Phase 1 trial to assess different doses of S- and N-based vaccines as boosters for previously vaccinated and/or infected individuals is ongoing in the first quarter of 2023. The safety, reactogenicity, and immunogenicity of the saRNA-based AAHI-SC vaccines as boosters will be studied in a Phase 1/2 trial. In a planned Phase 2 trial, the AAHI-SC vaccines will be compared to the currently available Janssen, Moderna or Pfizer-BioNTech vaccines.

Dr. Patrick Soon-Shiong
Global Chief Scientific and Medical Officer, ImmunityBio
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 design a vaccine that activates not only antibodies but also memory B and T cells to multiple antigens. Furthermore, room temperature-stable formulations for oral delivery have the potential to solve the cold-chain challenges of distribution, and the ability to generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.

Recent News

Dr. Patrick Soon-Shiong’s recent testimony to the U.S. Subcommittee on Africa, Global Health, and Global Human Rights addressed the need for a more durable and broad-acting #COVID vaccine that is room-temperature stable to increase vaccination rates in Africa. Link to recording

How Can ImmunityBio Help You?

Solutions for Patients

Many therapies for treating cancer and infectious disease severely weaken the immune system—the human body’s most important natural disease-fighting weapon. But ImmunityBio creates targeted, personalized immunotherapies that are designed to strengthen the immune system and enable it to outsmart your disease.

Opportunities for Trial Investigators

Immunotherapies and cell therapies are key to future cancer treatments. Our investigational IL-15 superagonist, N-803, and NK-92®-engineered cells have demonstrated wide therapeutic potential across multiple tumor types, and, in clinical studies, have proven to be well-tolerated, making them ideal for clinical trial investigations.

Solutions for Research Scientists

Our NK-92® cell line provides a versatile bioanalytical testing solution that helps researchers develop functional killing assays that are more consistent and reliable than donor blood and reporter gene assays.

ImmunityBio is continuously pursuing new immunotherapies designed to attack disease by enhancing the patient’s immune system, not weakening it.