The U.S. Food and Drug Administration (FDA) has granted investigational new drug status to the NANT cancer vaccine, to be assessed in a Phase 1/2 clinical trial (NCT03136406) for pancreatic cancer patients who progressed during or following standard-of care therapy.
The vaccine, developed by NantCell and NantKwest, is the first combination immunotherapy protocol that orchestrates the delivery of metronomic low-dose radiation and chemotherapy with molecularly informed tumor-associated antigen vaccines and off-the-shelf “natural killer” (NK) cells.
“Abraxane, a nanoparticle albumin-bound paclitaxel, was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years,” Dr. Patrick Soon-Shiong, chairman and CEO of NantKwest, said in a press release. “But we were not content just with the approval of Abraxane as being sufficient to transform this disease.”
Soon-Shiong said that in January 2016, the Los Angeles-based clinical-stage immunotherapy firm launched Cancer Breakthroughs 2020 — a program to develop effective personalized cancer treatments that further harness the human body’s innate immune system as a “paradigm change” to treating cancer patients.
“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,” Soon-Shiong said. “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.”
The vaccine, he said, consists of protein nanoparticles designed to deliver low-dose metronomic chemotherapy, combined with tumor-associated antigens that activate cells from the adaptive and innate immune system — dendritic and T-cells. The vaccine also contains IL-15, which activates NK cells, and off-the-shelf activated NK cells.
The upcoming clinical trial will assess the vaccine’s safety and efficacy in up to 80 pancreatic cancer patients who progressed on or after standard-of-care first-line therapy and chemotherapy.
Patients with a complete response in Phase 1 will enter the Phase 2 part of the study, and may remain for up to one year. Treatment will continue until disease progression, unacceptable toxicity or consent withdrawal, or until the investigators feel it is no longer in the subject’s best interest to continue treatment.
Nearly 54,000 Americans will develop pancreatic cancer this year, and just over 43,000 will die of the disease, according to American Cancer Society statistics. Pancreatic cancer accounts for about 3 percent of all U.S. cancer cases, and about 7 percent of all U.S. cancer deaths.
“Cancer has historically been one of the most complex” of all medical challenges, said Dr. John Lee, NantKwest’s senior vice-president of clinical development, adding that the FDA authorization is a testament to the company’s 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.”