Therapy Areas: AIDS & HIV
ImmunityBio, NantKwest Begin Dosing Participants in Global Trials for Novel COVID-19 Vaccine
9 March 2021 - - The first cohorts of US-based immunotherapy company ImmunityBio, Inc's and US-based clinical-stage, natural killer cell-based therapeutics company NantKwest, Inc's (NASDAQ: NK) South Africa and US COVID-19 vaccine trials have received their initial doses of the company's T-cell-based COVID-19 vaccine candidate, hAd5, the companies said.

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 US 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 US trials.

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.

The oral trial is a new study (NCT04732468) and the sublingual trial is the cohort C expansion to the Phase I subcutaneous trial (NCT04591717), which was initiated in October 2020.

Based on the findings of these trials, the optimal combination of administration route and dose will be determined and entered into the Phase II/III design.

As previously announced on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest.

The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.

ImmunityBio is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases.

The company's immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

This novel approach is designed to eliminate the need for high-dose chemotherapy, improve upon the outcomes of current CAR-T-cell therapies, and extend beyond checkpoint inhibitors.

ImmunityBio's platform is based on the foundation of three separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus vaccine technologies.

Anktiva (ImmunityBio's lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the US Food and Drug Administration for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

The company is also in Phase I or III trials for indications such as first- and second-line lung cancer, triple-negative breast cancer, metastatic pancreatic cancer, recurrent glioblastoma, and soft tissue sarcoma in combination with the company's synthetic immune modulator (Aldoxorubicin).

ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus vaccine technologies.

NantKwest (NASDAQ: NK) is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer cell therapies.

The activated NK cell platform is designed to destroy cancer and virally-infected cells.

The safety of these optimized, activated NK cells, as well as their activity against a broad range of cancers, has been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States.
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