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

  • Combination in 30 Patients with Advanced Metastatic Cancer Refractory
    to Multiple Previous Therapies
  • Zero Incidence of Cytokine Release Syndrome in Any of the 300 Doses in
    30 Patients
  • All Patients Received NK Cell Infusion and Novel Cancer Memory Vaccine
    Combination as Outpatients with No Immune-Related Adverse Events
  • In Highly Refractory Late-Stage (4th Line or Greater)
    Advanced Metastatic Triple Negative Breast Cancer, 80% Disease Control
  • In Highly Refractory Late-Stage Advanced Metastatic Pancreatic Cancer
    (3rd Line or Greater), 90% Disease Control with Median
    Overall Survival of 9.5 Months, Greater Than Historical Controls (8.7
    Months) in Patients with Standard of Care First Line Therapy
  • 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
  • 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) and 100% of Patients with Papillary Carcinoma Remain
    Disease-Free Following Fusion Protein Activation of NK and T Cells.

CULVER CITY, Calif.–(BUSINESS WIRE)–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.

Contacts

NANT
Jen Hodson
562-397-3639
Jen@nant.com

leverton

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