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it is just months away from beginning its first early-stage clinical trials, according to Paya.
Here’s how Immune Design sees this playing out: The company will initially focus on early clinical tests of LV305 alone, its adjuvant alone, and both combined, all while the combination immunotherapy trials are unfolding at Ludwig and CRI. Once Immune Design produces initial data from those early studies—Paya expects that that should roll in by the end of 2014—then the trial investigators can figure out which of Immune Design’s technologies to use with other cancer immunotherapy combinations.
If those studies produce the results Immune Design hopes they do, Paya says, Immune Design could leverage those data to try to work together with the company owning the other drug in the regimen. It could also begin evaluating its strategic options, such an IPO, a large partnership with a pharmaceutical company, or another potential exit strategy for its investors.
“We can then, in a way, choose which direction we would like to go,” he says. “My job is to drive to that value inflection point and then have a number of options to decide from.”
Immune Design was formed in 2008 by Nobel laureate David Baltimore of Caltech, Larry Corey of the Fred Hutchinson Cancer Research Center, and Steve Reed of the Infectious Disease Research Institute in Seattle. Paya, the former president of Elan, became CEO in April 2011.
The company is based on the combination of two ideas: first, a drug delivery technology that triggers a specific immune defense against specific targets by stimulating the dendritic cells of the immune system, which warn other cells of the immune system of invading pathogens. Second, the ability to combine that technology with its vaccine-boosting adjuvants, producing a more powerful, targeted immune response than vaccines of the past.
Immune Design first planned to use that technology to treat chronic infections such as herpes, and used its adjuvant to sign a $242 million partnership to help MedImmune enhance experimental vaccines for respiratory syncytial virus (RSV), Epstein-Barr virus, and cytomegalovirus (CMV) infections. But according to Paya, the company then saw a bigger opportunity for its technology in the field of cancer immunotherapy, where it could be used to stimulate the immune response of patients with weak immune systems.
Cancer immunotherapy dominated the headlines at the American Society of Clinical Oncology’s annual meeting this year as companies such as Bristol-Myers Squibb, Roche/Genentech, and Merck all presented compelling data on promising drugs that harness the power of the immune system to fight cancer.
“In a way, the timing was right, because now the field is exploding and we’re ready to go to the clinic in the next few months where we can test all these hypotheses in cancer patients,” Paya says. “[H]opefully [we can] be one of the companies that has the best technology to drive an immune response.”
Immune Design has raised $50 million in venture funding from The Column Group, Versant Ventures, and Alta Partners, and Paya says the company is in the process of raising a new round to bankroll all the early stage clinical trials it aims to start over the next year.