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The Cancer Letter Inc.
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publication date: Jan 15, 2016
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Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement 

 

Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

I made it very clear upfront—what we will do and I will do is I will be the cattle prod from the philanthropy perspective, and I will be the cattle prod from the private sector in getting the pharma and biotech to work together,” Soon-Shiong said. “What the vice president can do from his perspective is look at the inefficiencies inside the government from any of the agencies, but I’ve got to tell you, what was incredibly exciting is there wasn’t any roadblock from the regulatory agencies. I mean, the FDA was amazingly supportive—Bob Califf [nominated to be the next FDA commissioner] and Janet Woodcock [director of the FDA Center for Drug Evaluation and Research] and Peter Mark [deputy director for the FDA Center for Biologics Evaluation and Research] were incredibly supportive.”

Soon-Shiong said his interaction with NCI draws on the institute’s expertise through a Cooperative Research and Development Agreement. NCI officials say the existence of the CRADA cannot be construed as an endorsement of Soon-Shiong’s Cancer MoonShot 2020 program.

 

Matthew Ong: What led you to convene this coalition and put together your “Cancer MoonShot 2020” program?

Patrick Soon-Shiong: This is an evolution, and it started, obviously, way back, as I started developing Abraxane. And by 2005, as I got the drug approved, I began to recognize that the immune system is what we needed to protect.

And so I was pushing on the concept of low-dose chemotherapy as early as 2005. I trained under Donald Morton [founder of the John Wayne Cancer Clinic] at UCLA as an oncologist-surgeon, and he was one of the forefathers of immunotherapies, because he was working with melanoma tissue and injecting it with cancer vaccines.

So when CancerVax [the company Morton founded] unfortunately failed, Don turned to me, and I continue to help support it, because I really believed in it. It failed only because Don unfortunately had designed a trial incorrectly—he had BCG as a control arm, which is another immunotherapy, and without realizing it, he was comparing immunotherapy to immunotherapy.

Nonetheless, it was very clear to me that we need to protect the immune system and walk away from maximum tolerated dose chemotherapy, and as you know, writing through The Cancer Letter, our protocols haven’t changed at all, frankly, all these years in chemotherapy. That was my level of frustration.



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