• World’s first combination of tumor-targeted, off-the-shelf PD-L1-targeted Natural Killer cells with IL-15 fusion protein (N-803) to induce immune system activation of both the NK and T-cells demonstrated complete response in second-line metastatic pancreatic cancer, confirmed by PET/CT scan.
  • Results consistent with durable complete responses recently reported in Triple Negative Breast Cancer (TNBC) when off-the-shelf CD-16 NK therapy was combined with ImmunityBio’s N-803.
  • Over 130 doses of PD-t-haNK cells safely administered in Phase 1 trial with no severe treatment-related adverse side effects.
  • NantKwest plans to initiate registration trials in recurrent metastatic TNBC and pancreatic cancer patients that failed standard of care.
  • N-803 received Breakthrough Designation from the FDA for BCG Unresponsive CIS non-muscle invasive bladder cancer.
  • NantKwest plans to apply for Breakthrough Therapy Designation for advanced TNBC and pancreatic cancer.

CULVER CITY, Calif., January 14, 2020 – NantKwest Inc., (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company today announced results from their Phase 1 trial investigating a novel, first-in-human immunotherapy consisting of NantKwest’s off-the-shelf, PD-L1 tumor-targeted NK cells (NCT04050709). In addition, NantKwest and ImmunityBio, Inc., a privately held immunotherapy company, reported on a compassionate use expanded access IND combining the PD-L1-targeted NK cell with ImmunityBio’s IL-15 fusion protein (N-803) in a patient with metastatic pancreatic cancer who had relapsed after prior standard of care therapy. 

The findings on the Phase 1 safety and early signals of efficacy were reported by Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest, at the J.P. Morgan Healthcare Conference in San Francisco. 

“We hypothesize that a common treatment protocol that harnesses both the natural-killer cell and the T cells could be effective in treating cancer across multiple tumor types. This has been supported by the early signals of safety and efficacy in Phase 1 and 2 studies of NantKwest’s natural killer cells in advanced cancers. We recently reported at the 2019 Society for Immunotherapy of Cancer conference (SITC) complete responses in third-line Merkel cell carcinoma and fourth-line head and neck cancers when haNK CD-16 NK cells combined with Pfizer’s PD-L1 antibody, Avelumab, and with ImmunityBio’s N-803, an IL-15 superagonist were administered,” said Dr. Soon-Shiong. “Most recently we reported complete responses using combination therapies which included haNK, Avelumab and N-803 in Triple Negative Breast Cancer.  Durable complete responses were observed in these patients who had failed all standards of care therapy for breast cancer. The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in December 2019.“

“The evolution of the next generation NK in our platform was now to enable haNK cells to target tumors by expressing PD-L1 CAR (chimeric antigen receptor) on the surface of haNK NK cells.  These PD-L1.taNK NK cells have the properties of targeting PD-L1 on tumors, without the need of an additional PD-L1 checkpoint, Avelumab.”  

The FDA authorized the first-in-human safety studies of PD-L1.t-haNK (Quilt 3.064; NCT04050709) at doses of two billion cells administered bi-weekly as outpatients. No dose limiting or treatment-related events were noted in patients treated to date in this first dosing cohort. The study is now enrolling the dose cohort of four billion cells per infusion.

PD-L1.t-haNK Combined with N-803 IL-15 Protein for Treatment of Metastatic Pancreatic Cancer

An expanded access regimen incorporating N-803 with PD-L1.t-haNK was authorized to treat a patient with metastatic pancreatic cancer who had failed standard of care, based on the safety and efficacy data of the Phase 1 trial in 11 patients with metastatic pancreatic cancer who had received haNK and N-803. After five infusions of PD-L1.t-haNK and N-803, the patient’s tumor metastasis resolved completely per CT/Pet scan and the complete response has been confirmed by a repeat CT/Pet scan. Patient continues to receive ongoing treatment.

“We are extremely pleased that the FDA granted us this expanded IND authorization to initiate this novel immunotherapy treatment enabling the cross-talk of the innate natural killer system with the adaptive T cell,” said Dr. Soon-Shiong. “Achieving complete response in metastatic pancreatic cancer and durable, complete responses in metastatic TNBC patients that have failed all current standards of care is a promising finding which may further validate our approach to orchestrate both the innate and adaptive immune system,” continued Soon-Shiong. “Pancreatic cancer and TNBC are highly aggressive cancers with limited treatment options. These results are important, proof-of-concept supporting our hypothesis that comprehensively activating the immune responses of the NK, T and Dendritic cells, the “triangle offense”,  would induce immunogenic cell death leading to durable responses, even among this challenging patient population. Based on these encouraging findings, we plan to initiate clinical trials to confirm efficacy in second-line metastatic pancreatic cancer and third-line Triple Negative Breast cancer.”

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally induced 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 from the body. The safety of NantKwest’s optimized, activated NK cells, as well as their activity against a broad range of cancers, have 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 delivering living drugs in a bag and 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 https://www.nantkwest.com.

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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, 2019. 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.

About ImmunityBio 

ImmunityBio is a privately held immunotherapy company with a broad portfolio of biological molecules, including an albumin-linked chemotherapeutic, peptides, fusion proteins, cytokines, monoclonal antibodies, adenovirus, and yeast vaccine therapies.

ImmunityBio’s oncological goals are two-fold: To employ its broad portfolio of biological molecules to activate endogenous NK and CD8+ T cells, and to develop a T cell memory cancer vaccine to combat multiple tumor types without the use of high-dose chemotherapy. 

The company’s platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, addressing both the innate (activated macrophage and natural killer cell) and the adaptive immune system (dendritic, CD4 and CD8 killer T cells).  In 2020, ImmunityBio is planning to enroll patients in late-stage trials with molecules across multiple indications including triple negative breast cancer, lung cancer, head and neck cancer, Merkel cell carcinoma, and glioblastoma.

In the field of infectious disease, ImmunityBio’s goal is to develop vaccine therapies for the prevention and treatment of Influenza, Zika, Ebola, and HIV. For more information, please visit our website at https://www.immunitybio.com/

 

Forward Looking Statements

 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 cancer.  Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of ImmunityBio’s IL-15 based Cytokine therapy, N-803, and other therapeutics as part of the ImmunityBio portfolio.

 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.  We disclaim any obligation to update these statements except as may be required by law.

Investors Contact:

Investors@ImmunityBio.com

Investors@NantKwest.com