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ImmunityBio and NantKwest Begin Dosing Participants in Global Trials for Novel COVID-19 Vaccine; Subcutaneous Route in South Africa, Oral and Sublingual in the U.S.

Nachrichtenquelle: Business Wire (engl.)
08.03.2021, 15:00  |  383   |   |   

ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced the first cohorts of their South Africa and U.S. COVID-19 vaccine trials have received their initial doses of the company’s T-cell-based COVID-19 vaccine candidate, hAd5. This candidate is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus. These trials will determine which route combination provides the strongest immune response and long-term immunity, as well as the vaccine candidate’s effectiveness against the growing number of mutated variants of the virus.

In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation. The Phase I trial in Cape Town, South Africa is using subcutaneous administration and nine participants have been dosed to date. It is expected to be followed by sublingual delivery and room temperature-stable oral capsule trials. The two U.S. Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date. In total, 140 participants will be enrolled in the South African and U.S. trials.

“Current COVID-19 vaccines only target the S protein, the primary source of virus mutations. These mutations may render existing vaccines less effective, so we have designed our vaccine differently and are driving T cells to both S and N. Thus, the immune system could clear the infected cell rather than merely block the virus from entering the cell. This novel design could address the multiple mutations occurring globally today,” said Patrick Soon-Shiong, M.D., Executive Chairman of ImmunityBio and NantKwest.

Cape Town, South Africa Trial

The Phase I trial is being conducted at the Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa) Khayelitsha Clinical Research Site. Participants will receive two subcutaneous injections of the vaccine candidate 21 days apart and will be closely monitored for safety outcomes and immune responses generated. The evaluation of this novel COVID-19 vaccine, designed to be formulated in a room-temperature-stable capsule and can be administered sublingually, is a critical step for South Africa in the fight against the pandemic. The capsule and sublingual formulations protocol will be evaluated in a follow-on trial.

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ImmunityBio and NantKwest Begin Dosing Participants in Global Trials for Novel COVID-19 Vaccine; Subcutaneous Route in South Africa, Oral and Sublingual in the U.S. ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced the first cohorts of their South Africa and U.S. COVID-19 vaccine trials …

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