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NantKwest gets FDA OK to enroll for trials of cancer vaccine

May 12, 2017

NantCell and NantKwest Inc. (NASDAQ: NK), two pioneering, next generation, clinical-stage immunotherapy companies focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients (ClinicalTrials.gov NCT03136406).

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 Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. “But we were not content just with the approval of Abraxane as being sufficient to transform this disease. In January 2016, we announced our Cancer Breakthroughs 2020 journey towards developing effective personalized cancer treatments to further harness the human body’s innate immune system as a paradigm change to treating patients with cancer. Today’s FDA clearance is a further step in our 25-year quest to develop this cancer vaccine that seeks to induce immunogenic cell death and orchestrate the innate and adaptive immune system of the patient through the delivery of molecularly informed, biological platforms. To our knowledge this is the first clinical study whereby protein nanoparticles (Nab) delivering low dose metronomic chemotherapy is combined with molecularly informed (GPS Cancer) tumor associated antigens activating dendritic and T cells by adenoviral and yeast vectors, and orchestrated with both endogenous (IL-15) and exogenous (off the shelf) activation of NK cells. This NANT Cancer Vaccine will be studied in patients suffering from all types of cancers and at all stages of disease in the coming 12 months, a Cancer Breakthroughs 2020 goal,” Dr. Soon-Shiong added.

“Cancer has historically been one of the most complex challenges that the medical community has tried to combat,” said John Lee, MD, FACS, Senior Vice President of Clinical Development at NantKwest. “Receiving authorization from the FDA for the IND application for the NANT Cancer Vaccine is a testament to our novel immunotherapy approach. Today marks an important milestone for cancer care and reinforces the need for a paradigm shift in the way we approach this deadly disease. NantKwest and NantCell are actively working to initiate the clinical trial across investigational centers and we look forward to offering the NANT Cancer Vaccine regimen to pancreatic cancer patients.”

“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 Leonard S. Sender, M.D., Senior Vice President of Medical Affairs for Pediatric, Adolescent and Young Adult Oncology at NantKwest. “NANT Cancer Vaccine is a unique, multi-agent protocol aimed at orchestrating all the components of the immune system needed to combat cancer.”

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