Therapy Areas: Devices
First Patient Dosed in Phase 1 Clinical Trial of Second-Generation COVID-19 Vaccine Candidate Delivering Both Spike and Nucleocapsid of SARS-CoV-2
21 October 2020 - - The first patient has been dosed in the Phase 1 clinical trial of hAd5-COVID-19, a novel COVID-19 vaccine candidate that targets the inner nucleocapsid (N) and the outer spike (S) protein, engineered to activate both T cells and antibodies against the coronavirus (SARS-CoV-2), US-based immunotherapy company ImmunityBio, a privately-held immunotherapy company, and clinical-stage, natural killer cell-based therapeutics company NantKwest, Inc. (NASDAQ: NK) said.

This is a novel COVID vaccine that uses a second-generation adenovirus that delivers multiple proteins of the SARS-CoV-2 with the potential for long-term immunity through memory T cells.

The Phase 1 trial, which is being conducted at the Hoag Hospital in Newport Beach, California, is currently enrolling healthy adult subjects up to age 55 with the goal of examining the safety and reactogenicity of two doses of the vaccine candidate.

NantKwest and ImmunityBio's hAd5-COVID-19 vaccine candidate is a uniquely engineered, second-generation human adenovirus serotype 5 vaccine that has been designed to deliver both the spike protein and nucleocapsid protein by dual constructs of SARS-CoV-2 to potentially generate B and T cell memory to the COVID-19 antigens and long-term immunity to the virus.

Most of the COVID-19 vaccines in late-stage clinical trials deliver only the monovalent spike protein on the surface of the virus to generate blocking antibodies.

Modified to enhance the safety of the vector and immunogenicity of the COVID insert, ImmunityBio's novel human adenovirus vector has demonstrated preliminary safety in over 125 patients in 13 Phase I and 2 trials to date.

Clinical studies performed by the National Cancer Institute have demonstrated that this novel Ad5 vector induces antigen-specific T-cell immunity in patients, even in the presence of pre-existing adenoviral immunity.

NantKwest and ImmunityBio are currently enrolling 35 healthy adults aged 18 to 55 years old in the Phase 1 study for the hAd5-COVID-19 vaccine candidate (NCT04591717). hAd5-COVID-19 will be administered as both a prime and boost using the same vector platform to enable sustained protection against SAR-CoV-2.

The study's main objective is to examine the safety and reactogenicity of two doses of the vaccine. The companies are also pursuing development for oral, inhalational, and intranasal administration of hAd5.

Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. and its affiliate NantKwest, Inc. agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate.

Should a product be commercialized successfully, the companies have agreed to a 60-40 percentage split of net profits, with the larger share going to the company that developed the product.

The agreement also details the structure of shared governance of the joint collaboration.

The Hoag Center for Research and Education is a strategic and operational platform that selects, oversees and conducts government, industry, and foundation sponsored research trials translating early stage research and development into bedside patient care.

HCRE's aim is to provide the most advanced device technology, biopharmaceutical treatments, medical software and artificial intelligence health applications to the patients in our community and beyond.

HCRE leadership procures, allocates and oversees the resources and regulatory requirements demanded of clinical trials, including patient safety and outcomes.

Through nimble collaboration and efficient patient enrollment, HCRE conducts more than 150 trials annually. Trials span the entire spectrum of Hoag's institute programs, including Cancer, Neurosciences, Women's, Heart and Vascular, as well as individual investigator-initiated trials.

Examples include anti-cancer vaccine therapy trials, Phase 1 cancer therapeutics, advanced cardiac and radiology interventional tools, applications of virtual and augmented reality tools for patient education and neuromodulation, cutting edge molecular imaging targets, Alzheimer's detection and targeted biotherapeutics.

Since March, Hoag has participated in more than 20 COVID-19 clinical trials, providing patient access to cutting-edge therapies and innovative treatment including options that have documented improved outcomes, including decreased mortality and decreased length of stay for hospitalized COVID-19 patients.

ImmunityBio, Inc. 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 2 or 3 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 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.

By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwest's goal is to transform medicine by bringing novel NK cell-based therapies to routine clinical care.

NantKwest is a member of the NantWorks ecosystem of companies.
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