Ex-Dendreon CEO, Gold, Returns to Wall Street as Alpine, Nivalis Merge

Xconomy Seattle — 

Mitch Gold, the controversial executive who oversaw the rise of now-defunct cancer immunotherapy pioneer Dendreon, is about to head back to Wall Street.

Gold’s latest startup, Seattle cancer and autoimmune drug developer Alpine Immune Sciences, has struck a deal to go public by reverse merging with struggling Nivalis Therapeutics (NASDAQ: NVLS). Nivalis, of Boulder, CO, had been developing therapies for cystic fibrosis, but its lead drug failed a Phase 2 trial in November, leaving the company’s fate unclear. Nivalis announced a strategic review and a restructuring earlier this year, and ultimately came to a deal with Alpine.

Nivalis’s failure has created an opportunity for Alpine to sidestep an IPO, a strategy a number of privately held biotechs have used over the years to go public more quickly and cheaply. In the deal, Alpine’s shareholders OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures—the biotech hedge fund that seeded Alpine and that Gold helped form in 2013 with former investment analyst David Miller—will pump $17 million in new cash into the combined company. That will leave Alpine’s stockholders with a 74 percent stake, and Nivalis’s shareholders with the remaining 26 percent.

The new company will be renamed Alpine, headed by Gold (pictured) as chairman and CEO, and will have $90 million in cash after the deal closes. Nivalis will keep two seats on what will now be a seven-member board of directors.

The move marks a return to the public markets for Gold, who had a controversial run as the former CEO of Dendreon. Gold led a pioneering effort in the field of immunotherapy by beating the odds to win FDA approval of sipuleucel-T (Provenge), an immunotherapy for prostate cancer, in April 2010. Gold raised about $2 billion to help Dendreon bring the drug to market and pocketed almost $27 million in two days of share sales after sipuleucel-T won FDA approval. But the treatment was a commercial bust for a variety of reasons, so Dendreon faltered, was buried in more than $600 million in debt, and filed for bankruptcy in 2014. Sipuleucel-T was ultimately sold to Valeant Pharmaceuticals (NYSE: VRX).

Yet since Dendreon’s FDA approval, immunotherapy has gained steam. Several antibody drugs called checkpoint inhibitors are now approved for a variety of cancers, and the first approved cell therapies known as “CAR-T” treatments—which, like sipuleucel-T, use a patient’s own cells—could hit the market this year. While immunotherapy’s reach at this point remains limited, its appeal and potential is significant, which is why there is so much money being invested in improving it.

Gold, meanwhile, left Dendreon in 2012 and has since enjoyed more success in the biotech startup world. He founded Alpine Biosciences in 2012, which was sold to Oncothyreon (now Cascadian Therapeutics) for $27 million in an all-stock deal. He formed Alpine BioVentures a year later, and then seeded Alpine in 2015.

Alpine is developing new protein-based immunotherapies with an in-house technology that’s able to bind to multiple targets in the immune synapse—where immune cells connect with one another—rather than a single one, like most approaches. The company says it’s able to impact these interactions with a single molecule, and either spur on or tamp down an immune response, meaning its approach might have use either for cancer or autoimmune or inflammatory diseases. The company does this by engineering specific types of ligands (signaling molecules) meant to bind to more than one target simultaneously.

Alpine doesn’t have any clinical data to support this approach as of yet—its first trial won’t begin until late next year. But Alpine’s work in cancer did attract the interest of Kite Pharma (NASDAQ: KITE) in 2015, which struck a collaboration with the company on a separate technology that might help boost the effectiveness of CAR-T treatments.