- First two cohorts fully enrolled; Low dose cohort reports no serious adverse events (SAEs), high dose cohort safety analysis ongoing
- Subject screening is ongoing for Phase I expansion cohorts
- Phase 2 / 3 hAd5 COVID-19 trial in design
CULVER CITY & EL SEGUNDO, Calif., November 10, 2020 — ImmunityBio, a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have administered their second-generation bivalent, human adenovirus (hAd5) COVID-19 vaccine candidate in a Phase 1 trial with no SAEs reported in the low dose cohort, safety assessments are ongoing for the high dose cohort. The trial, being conducted at Hoag Hospital in Newport Beach, California, has enrolled 20 volunteers across two dose levels and subject screening for the Phase I expansion cohort is ongoing.
Developed by ImmunityBio and manufactured by NantKwest, this second generation hAd5-vector vaccine is unique in targeting both spike (S) and nucleocapsid (N) SARS-CoV-2 proteins. The vaccine is designed to generate both antibodies and CD4+ and CD8+ T cell responses, all of which we believe are necessary for generating long-term immune memory. A recent study of responses of T cells from convalescent plasma collected from previously-infected SARS-CoV-2 patients demonstrated that the hAd5 vaccine could stimulate recall of SARS-CoV-2 specific CD4+ and CD8+ memory T cells from these patients to the S and N proteins delivered by the hAd5-COVID-19 vaccine. This finding of immune recall suggests that the hAd5 COVID-19 vaccine could potentially elicit cell-mediated immune responses in convalescent, previously infected patients to stimulate and boost memory T cells specific to SARS-CoV-2.
“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. “Given the urgent need for long-term protection from SARS-CoV-2 viruses and the alarming increase of infection in our country, we’re heartened by what we’ve observed so far and hope to be able to move quickly to a Phase 2/3 randomized, double-blind control trial, involving a larger group of volunteers including persons previously infected with SARS-CoV-2.”
Phase 1 Trial Design
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 (5×1010 and 1×1011 viral particles). Participants receive two subcutaneous injections 21 days apart. The study’s primary objective is to examine the safety and reactogenicity of two doses of the vaccine. Additionally, immunogenicity, duration of immune response, and occurrence of symptomatic COVID-19 will be assessed.
For more information about the trial, please contact firstname.lastname@example.org.
Unique Design of ImmunityBio’s hAd5 Adenovirus-Based COVID-19 Vaccine
Leveraging knowledge gained and using tools in-hand from ImmunityBio’s ongoing development of an adenovirus-based vaccine for the treatment of cancer (The NANT Cancer Vaccine), the company has developed a unique second-generation COVID-19 vaccine. This vaccine is distinctive in multiple aspects of design from the current COVID-19 vaccines in late-stage clinical trials, including:
- the adenovirus vector platform (E2b-deleted region within hAd5)
- the immunogenic SARS-CoV-2 protein antigens selected (S & N)
- the potential for antibody and T cell immune response enhanced by molecular trafficking of the SARS-CoV-2 N protein to lysosomal intracellular compartments
- the potential to provide multiple routes of administration (subcutaneous, intranasal and oral) to potentially achieve mucosal, antibody, and long-term cell mediated immunity
- the possibility to overcome cold-chain limitations with refrigerated (-20 °C and 2-8 °C) and room temperature-stable vaccines
About the ImmunityBio and NantKwest Joint Collaboration Agreement
Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. and its affiliate NantKwest, Inc. (NASDAQ: NK) 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.
ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate 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 the outcomes of current CAR T-cell therapies, and extend beyond checkpoint inhibitors.
ImmunityBio has established three fundamental platforms to drive long-term immunological memory. These include first-in-class antibody cytokine fusion proteins, synthetic immune modulators, and second-generation vaccine vector platforms.
ImmunityBio’s lead cytokine infusion protein, a novel interleukin-15 (IL-15) superagonist complex (AnktivaÔ), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, 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 (hAd5) vaccine platform.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities and clinical trials.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
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 (NK) 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. 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. For more information, please visit www.nantkwest.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer or other critical illnesses, including COVID-19. Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are described in detail in its Securities and Exchange Commission filings, including in NantKwest’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.