Soon-Shiong's I-O outfits get FDA nod to start cancer vaccine trials

Human tumor cells from the pancreas
The phase 1b/2 study should generate results in 2018.

Biotech billionaire Patrick Soon-Shiong has been through the media wringer in the last few months, and so he'll welcome an FDA green light that will draw attention back to his immuno-oncology programs.

The U.S. regulator has just granted approval to Soon-Shiong's immuno-oncology companies NantKwest and NantCell to start recruiting patients into the first clinical trial of a cell-based immunotherapy for pancreatic cancer.

The NANT Cancer Vaccine is billed as the first combination of off-the-shelf natural killer (NK) cells and a "molecularly informed tumor associated antigen vaccine," given along with low-dose radiotherapy and chemotherapy. The phase 1b/2 clinical trial will test the immunotherapy in around 80 people with pancreatic cancer whose disease has progressed despite first-line standard-of-care therapy, and is due to complete before the end of next year.

Best known for bringing Abraxane to market and selling the drug and company Abraxis to Celgene for nearly $3 billion in 2010, Soon-Shiong has been making headlines of late with his NIH-partnered Cancer Moonshot 2020 consortium, which aims to have new therapies for 20 tumor types in trials involving 20,000 patients by that year.

Critics have cited a lack of progress in that initiative, however, while Soon-Shiong has also had to weather allegations that he has been donating millions of dollars to philanthropic causes, only to claw back the money into businesses he himself owns. A donation to the University of Utah is being investigated by state lawmakers, reports STAT. The biotech magnate has taken to Twitter to refute those claims and talk up the prospects for the NANT Cancer Vaccine.

The pancreatic cancer trial is the a key step forward for the Moonshot 2020 program, he said, adding that NantKwest and NantCell are actively working to initiate the clinical trial across investigational centers.

"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," said Soon-Shiong.

It seems he could not resist indulging in a little hyperbole, however, saying that vaccine will be studied "in patients suffering from all types of cancers and at all stages of disease in the coming 12 months."