Seattle-based Immune Design took a big step forward as a company in 2010 when it struck a deal to let AstraZeneca’s MedImmune unit test out its proprietary vaccine boosters, or adjuvants. Now, it’s got a bigger goal in mind: using a broad collaboration with two big non-profit organizations to break into the hot field of cancer immunotherapy.
Immune Design has formed a partnership with the Ludwig Institute for Cancer Research and the Cancer Research Institute, two New York-based non-profits that support cancer research and sponsor and conduct clinical trials. The partnership doesn’t include any particular financial consideration for Immune Design. Rather, it’s about access, and setting up the company’s long-term business plan.
Specifically, should Immune Design show that two of its experimental drugs—a vaccine (LV305) designed to stimulate an immune system response, and a synthetic chemical compound known as an adjuvant (glucopyranosyl lipid A) used to boost the vaccine’s effectiveness—are both safely tolerated, and have a meaningful clinical effect in humans, investigators running clinical trials at Ludwig and CRI could potentially add them into studies testing combinations of cancer immunotherapies.
“These are things as a small private company we would not have been able to afford,” says Immune Design CEO Carlos Paya. “[It] allows companies like ours that don’t have all the tools together to have our tools being tested in combination with other companies’ tools.”
Immune Design hopes to ultimately show through these trials that a cancer immunotherapy drug works better with the help of its vaccine and adjuvant. The Ludwig institute and CRI, for example, signed a deal with MedImmune in October allowing the organizations to use three of its cancer antibodies—among them tremelimumab, which belongs to a class of drugs designed to release the braking mechanism in the immune system called CTLA-4—in clinical trials of cancer immunotherapy combinations.
Trial investigators could, for example, ultimately decide to combine something such as tremelimumab with Immune Design’s boosted vaccines to create a more potent treatment.
“If you combine a big engine of making an immune response with these [CTLA-4 blocking antibodies], the obvious logic would be that you have synergy or additive value,” Paya says.
That’s a lot of if’s and uncertainty to get through. But the partnership does get Immune Design’s foot in the door, right as 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.
“We expect to have that cash soon, in the next three to four months,” he says.