NantKwest Announces Promising First in Human Clinical Results of 300 Doses Of CD16 Targeted, Off-The-Shelf Cryopreserved Natu...
08 11월 2018 - 7:28AM
Business Wire
- 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.
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 Antigens5. Yeast (Ye)
Vaccine-Delivering Personalized Tumor Antigens6. 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.
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NANTJen Hodson562-397-3639Jen@nant.com
NantKwest (NASDAQ:NK)
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