NantKwest

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.

Retrieved on: 
Monday, March 8, 2021

In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation.

Key Points: 
  • 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.
  • Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date.
  • This novel design could address the multiple mutations occurring globally today, said Patrick Soon-Shiong, M.D., Executive Chairman of ImmunityBio and NantKwest.

ImmunityBio and NantKwest Announce FDA Authorization to Study hAd5 T-Cell COVID-19 Vaccine for Combination of Subcutaneous, Oral and Sublingual Boost to Induce T-Cell, Mucosal, and Antibody Immunity

Retrieved on: 
Thursday, February 11, 2021

The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts.

Key Points: 
  • The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts.
  • The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration.
  • Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California.
  • The first two cohorts of the Phase Ib, open label, dose-ranging study (NCT04591717) of the vaccine received two different dose levels (.5 and 1ml).

ImmunityBio Announces Positive Phase 2 Results Showing That Anktiva Restores the Activity of Checkpoint Inhibitors in Patients Who Have Relapsed Checkpoint Immunotherapy in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, January 28, 2021

These encouraging safety and efficacy data suggest that the addition of Anktiva to checkpoint inhibitors has the potential to restore and/or enhance sensitivity to checkpoint inhibitors.

Key Points: 
  • These encouraging safety and efficacy data suggest that the addition of Anktiva to checkpoint inhibitors has the potential to restore and/or enhance sensitivity to checkpoint inhibitors.
  • Tumor resistance to checkpoint therapy occurs when T cells are unable to recognize the tumor cell antigen.
  • Thus, the potential exists that Anktiva could be the combination backbone to all checkpoint therapy by activating both NK and T cells.
  • Lung cancer is the second most common cancer in men and women (excluding skin cancer), and non-small cell lung cancer accounts for 80% to 85% of all lung cancers, according to the American Cancer Society.

 ImmunityBio Announces Phase I Trial of COVID-19 Vaccine Candidate in South Africa as New Variants of SARS-CoV-2 Spread

Retrieved on: 
Tuesday, January 19, 2021

The same vaccine is currently being tested in a similar Phase I trial in the U.S., with no safety concerns identified to date.

Key Points: 
  • The same vaccine is currently being tested in a similar Phase I trial in the U.S., with no safety concerns identified to date.
  • These exciting results have catalyzed our interest in pursuing human trials of the oral vaccine in South Africa.
  • Understanding sensitivities related to adeno vaccine platforms in South Africa, we have taken the utmost care in designing our trial, said Dr. Amy Ward, principal investigator of the Phase I trial.
  • ImmunityBio has engaged with government agencies and indicated a commitment to ensuring this vaccine is available in South Africa.

ImmunityBio Simulations Reveal Why the New Strain of SARS-CoV-2 in South Africa is Spreading Fast and May ‘Escape’ Existing Immunity

Retrieved on: 
Tuesday, January 19, 2021

In the new study, MD simulation was applied to the highly concerning new strains of SARS-CoV-2 including the predominating variant in South Africa 501Y.V2 and the UK variant B.1.1.7.

Key Points: 
  • In the new study, MD simulation was applied to the highly concerning new strains of SARS-CoV-2 including the predominating variant in South Africa 501Y.V2 and the UK variant B.1.1.7.
  • As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest.
  • ImmunityBio, Inc. is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases.
  • Copies of documents filed with the SEC will also be available free of charge from NantKwest using the sources indicated above.

NantKwest, ImmunityBio Announce Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Trials

Retrieved on: 
Wednesday, January 13, 2021

The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer.

Key Points: 
  • The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer.
  • Based on the data from these trials, ImmunityBio is conducting a pivotal, three-cohort pivotal trial (QUILT 88) in metastatic pancreatic cancer.
  • A randomized Phase 2 study (QUILT 88, Cohorts A and B) for first- and second-line metastatic pancreatic cancer is actively enrolling at three sites.
  • On the basis of our initial studies, we initiated our QUILT 88 randomized trials in metastatic pancreatic cancer and are pleased to present today those findings, including Cohort C survival rates.

NantKwest Executive Chairman Dr. Patrick Soon-Shiong to Present at 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021

Retrieved on: 
Wednesday, January 6, 2021

NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced that Dr. Patrick Soon-Shiong M.D., Executive Chairman of the Board of Directors, will participate in the 39th Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced that Dr. Patrick Soon-Shiong M.D., Executive Chairman of the Board of Directors, will participate in the 39th Annual J.P. Morgan Healthcare Conference.
  • Dr. Soon-Shiong will also provide an update on the clinical progress of the two companies individual and collaborative therapies.
  • 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.
  • Copies of documents filed with the SEC will also be available free of charge from NantKwest using the sources indicated above.

ImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company

Retrieved on: 
Monday, December 21, 2020

The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.

Key Points: 
  • The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.
  • ImmunityBio is a leading late stage immunotherapy company activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune system to treat serious unmet needs within oncology and infectious diseases.
  • The company has established a robust next generation immunotherapy clinical pipeline with a strategy toward registrational intent in various indications, beyond checkpoint therapy treatment alone.
  • ImmunityBio, Inc. is a late stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease.

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

Retrieved on: 
Friday, December 11, 2020

By protecting the nasal passages (the primary point of entry for the virus), the vaccine has the potential to reduce reinfection.

Key Points: 
  • By protecting the nasal passages (the primary point of entry for the virus), the vaccine has the potential to reduce reinfection.
  • This study was designed to test the safety, immunogenicity and protection from infection and disease provided by ImmunityBios hAd5-COVID-19 vaccine.
  • ImmunityBios hAd5 vaccine activated T cells to provide protection, and N was particularly effective in this role.
  • ImmunityBios platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.

ImmunityBio, NantKwest Announce Positive Interim Phase 1 Safety Data of hAd5 COVID-19 Vaccine Dose Study

Retrieved on: 
Tuesday, November 10, 2020

We are grateful to the many volunteers who are participating in this important Phase 1 study of our COVID-19 vaccine candidate, said Patrick Soon-Shiong, M.D., Chairman and CEO of ImmunityBio.

Key Points: 
  • We are grateful to the many volunteers who are participating in this important Phase 1 study of our COVID-19 vaccine candidate, said Patrick Soon-Shiong, M.D., Chairman and CEO of ImmunityBio.
  • The Phase 1, open-label, dose-ranging study is being conducted on 35 participants aged 18 to 55 years old (NCT04591717).
  • The volunteers are divided into three groups, and each group receives different doses of the vaccine (5x1010 and 1x1011 viral particles).
  • The studys primary objective is to examine the safety and reactogenicity of two doses of the vaccine.