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Press Release

NantKwest Announces Promising First in Human Clinical Results of 300 Doses Of CD16 Targeted, Off-The-Shelf Cryopreserved Natural Killer Cells (haNK) in a Novel Cancer Memory Vaccine Immunotherapy

NantKwest Inc.
Posted on: 08 Nov 18

The recent successes of immunotherapy, such as checkpoint inhibition, have spawned a wave of enthusiasm for immuno-oncology. Unfortunately, only a subset of cancer patients respond to checkpoint inhibitor monotherapy, and many of these checkpoint-responsive patients will eventually relapse. In addition, cellular therapy in the form of CAR-T cells has shown little evidence of effectiveness in solid tumors. Thus, there remains a huge unmet need to address the rising pandemic of cancer with a paradigm shift in treatment. One such opportunity is to orchestrate, at a molecular level, the complete immune system by a protocol that unleashes cellular therapy in the form of Natural Killer (NK) cells, T cells, dendritic cells and macrophages — the effector cells responsible for tumor cell death — with simultaneous activation of the body’s signaling system of cytokines and chemokines to induce Immunogenic Cell Death (ICD). This paradigm change holds the potential to coordinate NK and T cells responses while inducing ICD with metronomic chemo-radiation, and a common cancer vaccine for all tumor types regardless of anatomical origin.

A fundamental principle is to avoid high dose chemotherapy and utilize low dose metronomic, albumin-based chemo combination therapy with NK and T cell immuno-stimulatory fusion proteins. The novel approach of this Cancer Memory Vaccine is to activate the patient’s own NK cells with fusion proteins, supplemented by administration of off-the-shelf tumor targeted NK cell infusions, combined with inducing neoantigen and tumor associated antigen-specific memory T cells using adenovirus and yeast vaccines. Through this novel approach, the goal is activation of the entire immune system to induce antigen-specific memory T cells through the orchestration of immunomodulatory and immuno-stimulatory immune cells. The vision of Dr. Soon-Shiong’s novel Cancer Memory Vaccine, building on the approved nanoparticle (Nab-Paclitaxel, Abraxane) is to achieve chemo-free, biologically driven immunotherapy for the early treatment and prevention of cancer beyond 2020.

Dr. Patrick Soon-Shiong, Chairman & CEO of NantKwest said, “High dose, uninformed, toxic chemotherapy damages the immune system and induces what is known as tolerogenic cell death. Natural Killer cells are the core innate immuno-protective mechanism against cancer. By developing a system of activating the patient’s own Natural Killer cells and T cells, as well as augmenting the patient’s NK killing ability with engineering off-the- shelf NK transfusions, we hypothesize that resistant cancer can be overcome. We believe that current checkpoint inhibitors alone are insufficient to achieve long-term remission and only by inducing both the innate and adaptive immune system, and by orchestrating the treatment in a temporal-spatial sequence, will we induce T cell memory and long-term durable response. These early results of 300 doses of the Cancer Memory Vaccine in 30 patients over the course of the last 14 months are encouraging and suggest that we may be on the correct path to a paradigm change, leading ultimately to a chemo-free treatment of cancer patients, early in the course of their disease and ultimately to a path of cancer prevention.”

From August 2017 to October 2018, safety and efficacy clinical trials were completed using this novel first-in-human combination immunotherapy cancer vaccine and the data were presented by Dr. Patrick Soon-Shiong at the 2018 Society of Immunotherapy of Cancer (SITC) in Washington, DC. Summary of the data presented is as follows:

  • First-in-Human Novel Immunotherapy Combination: The Cancer Memory Vaccine Beyond Checkpoints
    • First Immunotherapy Combination of:
      1. Low Dose Metronomic Nab-Paclitaxel (Abraxane)
      2. Off-The-Shelf Cryopreserved Targeted Natural Killer Cells (haNK)
      3. NK & T Cell Stimulators by IL-15 Fusion Protein (N-803)
      4. Adenovirus (Ad) Vaccine-Delivering Personalized Tumor Antigens
      5. Yeast (Ye) Vaccine-Delivering Personalized Tumor Antigens
      6. Checkpoint Inhibitor (PD1 and PD-L1)
  • Evidence of Clinical Safety in the Outpatient Setting of the Cancer Memory Vaccine Combination
    • 30 Patients Receiving 300 Doses (August 2017 - October 2018) of CD16 Engineered Off-The- Shelf Natural Killer Cells (haNK) With No Immune Related Adverse Events (irAE)
    • Compared Favorably to that of Patients Receiving CAR T Cell Therapy: Zero Incidence of Cytokine Release Syndrome in Any Patient Receiving NK Cell Therapy
  • Early Clinical Efficacy of Results of Cancer Memory Vaccine Combination Are Highly Promising
    • In Highly Refractory Patients with Advanced Metastatic Triple Negative Breast Cancer (4th Line and Greater), the Cancer Memory Vaccine Resulted in 80% Disease Control
    • In Highly Refractory Patients with Advanced Metastatic Head and Neck Cancer (4th Line and Greater), the Cancer Memory Vaccine Resulted in 67% Disease Control with a Complete Response in One Patient
    • In Highly Refractory Patients with Advanced Metastatic Pancreatic Cancer (3rd Line or Greater), the Cancer Memory Vaccine Resulted in 90% Disease Control and a Median Overall Survival of 9.5 Months (Exceeded the Historical Overall Median Survival in First Line Patients of 8.7 Months)
  • Early Clinical Efficacy of Results of Endogenous NK Activation by Fusion Protein Are Highly Promising
    • Utilizing Endogenous NK Stimulation Alone with IL-15 Fusion Protein (N-803) in Refractory Patients with Bladder Cancer who Failed Standard of Care, 86% Complete Response Was Achieved in Patients with Carcinoma In-Situ (CIS) of the Bladder Following Fusion Protein Activation of NK and T Cells
    • Utilizing Endogenous NK Stimulation Alone with IL-15 Fusion Protein (N-803) in Refractory Patients with Bladder Cancer who Failed Standard of Care, 100% of Patients with Papillary NMIBC (High-Grade Ta/T1) Remain Disease-Free for 3 to 15 Months (All Ongoing to Date) Following Fusion Protein Activation of NK and T Cells
    • NantKwest has Entered in an Exclusive Collaboration Agreement with NantCell to Combine Off-The-Shelf Targeted NK Cells with IL-15 (N-803)

About NantKwest Inc.

NantKwest is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases and inflammatory diseases.

NantKwest is uniquely positioned to implement precision cancer medicine, with the potential to change the current paradigm of cancer care. Natural Killer cells are ancient cells in the human body designed to recognize and detect cells under stress or infected. The NantKwest “off-the-shelf” activated Natural Killer (NK) platform has the capacity to destroy cancer and virally infected cells from the body. The safety of our NK cells as well as their activity against a broad range of cancers have been tested in multiple phase 1 clinical trials in the United States, Canada and Europe. In addition to our NK cells capability to be administered in the outpatient setting as an “off-the-shelf” living drug, it serves as a universal cell-based therapy without need for individualized patient matching. Moreover, our NK cell based platform has been bioengineered to incorporate chimeric antigen receptors (CARs) and antibody receptors to further optimize targeting and potency in the therapeutic disease.

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 NantKwest 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 our NK cells as well as other therapeutics as part of the NANT Cancer Vaccine platform as a cancer treatment.

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 our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181107005969/en/

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Last updated on: 08/11/2018

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