[4] Joe O'Neill was appointed as CEO in 2005,[5] because of his work as the chief architect of the President's Emergency Plan for AIDS Relief, known as PEPFAR.
[13] Nature Medicine later reported on an independent group of scientists at Stanford University who published results of a Phase I clinical trial using this technology to treat patients suffering from B-cell lymphoma.
[14] After incubation and pre-clinical validation by IRC, the dendritic cell product was licensed to a startup in exchange for founders stock, $500,000 in cash and royalties.
The cell-based immune therapy, based on that invention, Sipuleucel-T, more commonly known as Provenge, became the first FDA-approved immunotherapeutic cancer vaccine.
[23] Its developer, Novartis, required a complex manufacturing infrastructure capable of delivering an immunotherapeutic of consistent quality in order to produce the clinical and commercial quantities needed to obtain FDA approval.
[23][24] On August 13, 2017, Kymriah became the world's first gene therapy to reach the market,[25] an approval that was recognized by FDA Commissioner Scott Gottlieb with these remarks, "Today marks another milestone in the development of a whole new scientific paradigm of the treatment of serious diseases.
He wrote, "The study was stopped prematurely due to the decrease in AIDS-related illness resulting from the introduction of more effective antiviral drug combinations.
The problematic outcome adversely impacted funding, and so, after raising $350 million, the Company abandoned the project and liquidated its assets in 2008.