NantKwest and NantCell Announce FDA Authorization for the NANT Cancer Vaccine Clinical Trials, the First Novel Combination of Innate and Adaptive Immunotherapy in Patients with Pancreatic Cancer
The NANT Cancer Vaccine, the First Simultaneous Combination of Off the Shelf Natural Killer Cells (NK) With Endogenous Adaptive Dendritic, T Cell and NK Cell Activation
Personalized Molecular Informed Therapy with
A Cancer Breakthroughs 2020 Milestone to Address Multiple Cancer Types at All Stages of Disease
The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low-dose radiation and chemotherapy with molecularly-informed, tumor-associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.
“Abraxane, a nanoparticle albumin-bound (Nab) paclitaxel, was the first
protein-based drug to alter the survival of metastatic pancreatic cancer
in over 20 years,” noted
“Cancer has historically been one of the most complex challenges that
the medical community has tried to combat,” said
“Cancer cells often go undetected by the immune system; recently, it was
found that cancer cells place a brake on the immune system by checkpoint
receptors. This discovery has brought forth a new revolution of
immuno-oncology with the launch of multiple checkpoint inhibitors. We
realize, however, that checkpoint inhibition alone is insufficient to
fully activate the immune system to combat the cancerous tumor,” stated
Cautionary Note Concerning 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, among others, statements concerning
or implying the timing and conduct of our clinical studies, the
anticipated safety and efficacy of our NK cell therapy and the
accomplishment and timing of related regulatory determinations and
filings. 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. Risks and uncertainties include, but are not
limited to, the rate of subject enrollment in our clinical studies; the
number of subjects that will need to be enrolled in the trial;
difficulty obtaining and maintaining regulatory approvals; our limited
experience in conducting clinical studies and significant issues
regarding our clinical studies, including, but not limited to, the
successful opening and the continued participation of clinical sites and
their ongoing adherence to protocols, assumptions regarding enrollment
rates, timing and availability of subjects meeting inclusion and
exclusion criteria, changes to protocols or regulatory requirements, the
ability to comply with and meet applicable laws and regulations,
unexpected adverse events or safety issues and the sufficiency of
funding and adverse events affecting our ability to manufacture and
supply cell therapy for our clinical studies. There can be no assurance
that data from any of our clinical studies will be sufficient to support
an application for marketing in any country or that any such application
will ever be approved. These and other risks regarding our business are
described in detail in our
About NANT Cancer Vaccine
The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low dose radiation and chemotherapy with molecularly informed tumor associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.
About
NantKwest’s unique NK cell-based platform, with the capacity to grow active killer cells as a biological cancer therapy, has been designed to induce cell death against cancer or infected cells by three different modes of action: (1) Direct killing using activated NK cells (aNK) that release toxic granules directly into the cell through cell to cell contact, (2) Antibody-mediated killing using haNKs, which are NK cells engineered to incorporate a high affinity receptor that binds to an administered antibody, enhancing the cancer cell killing effect of that antibody, and (3) Chimeric Antigen Receptor (CAR) activated killing using taNKs, which are NK cells engineered to incorporate CARs to target tumor-specific antigens found on the surface of cancer cells.
Our aNK, haNK® and taNK TM platform addresses certain limitations of T cell therapies including the reduction of risk of serious “cytokine storms” reported after T cell therapy. As an “off-the-shelf” therapy, NantKwest’s NK cells do not rely on a patient’s own often compromised immune system. In Phase 1 clinical trials in patients with late stage cancer, NantKwest’s NK cells have been successfully administered as an outpatient infusion therapy without any reported severe side effects, even at doses of 10 billion cells.
By leveraging an integrated and extensive genomics and transcriptomics
discovery and development engine, together with a pipeline of multiple,
clinical-stage, immuno-oncology programs that include a Phase 2 trial
for a rare form of melanoma and the planned initiation of a clinical
trial of NK cells targeted to breast cancer, we believe
About NantCell
NantCell, a wholly-owned subsidiary of
NantCell's mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive “omic” analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive “omic” analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. Through these integrated diagnostic methods, the company is pursuing the vision of treating the biology of cancer rather than the anatomy, and driving the immune system inherited by all to defeat cancer. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.
About
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Source:
NantWorks
Jen Hodson, 562-397-3639
jhodson@nantworks.com