FDA authorizes for the NANT Cancer Vaccine Clinical Trial
NantCell and NantKwest announced that the FDA has authorized NANT Cancer Vaccine for clinical trial enrollment (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.
Leonard S. Sender Senior VP of Medical Affairs for Pediatric, Adolescent and Young Adult Oncology at NantKwest said that 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. They realize, however, that checkpoint inhibition alone is insufficient to fully activate the immune system to combat the cancerous tumor. Nant Cancer Vaccine is a unique, multi-agent protocol aimed at orchestrating all the components of the immune system needed to combat cancer.
NantKwest Chairman and CEO, Patrick Soon-Shiong said that nanoparticle albumin-bound (Nab) paclitaxel, Abraxane was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years. To their 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.