put together a new management team of industry veterans that includes Stephen Brady, the chief business officer; Richard Kenney, the chief medical officer; Jan Henrick ter Meulen, the chief scientific officer; and Frank Hsu, the vice president and head of oncology. Brady and Kenney are based in the San Francisco Bay Area, and the company has agreed to open a new office there for them, and to house more of the clinical development team as the company grows, Paya said. For now, Immune Design plans to keep its team lean with about 30 employees, so that it can use all of its existing resources to run a series of clinical trials that will establish safety and some early signs of effectiveness over the next three years, Paya said.
Paya, an immunologist and former faculty member at the Mayo Clinic, joined Immune Design a little more than two years ago. He came to the company after a stint as the president of Elan, the company that had part ownership in the hit multiple sclerosis drug natalizumab (Tysabri), when he was there. Paya’s new team comes with a lot of experience at places like Merck, Crucell, Genzyme, and Proteolix.
Immune Design has always had plenty of big names on its side. Its board includes Baltimore (the Nobel laureate biologist); Ed Penhoet, the founder and former CEO of Chiron; and Bruce Carter, the former CEO of ZymoGenetics. The scientific advisory board is similarly loaded, with Carl June of the University of Pennsylvania; Larry Corey of the Fred Hutchinson Cancer Research Center; Inder Verma of the Salk Institute; and Rick Klausner, the former head of the National Cancer Institute, now with gene sequencing powerhouse Illumina (NASDAQ: [[ticker:ILMN]]).
Skeptical readers at this point know that lots of biotech companies that rally big scientific names never amount to anything. So what does Immune Design actually do? It takes a little bit of science to get a grasp on that.
Immune Design was founded five years ago with technology from Baltimore’s lab at Caltech. The Baltimore lab contributed modified lentiviruses that are supposed to get inside cells, and act as targeted vehicles for immune stimulation. Targeted immune boosting is thought to be better than general immune boosting, because it should be more potent, and be less likely to provoke an immune response against healthy tissue—known as autoimmunity.
Besides Baltimore’s targeting vectors, the company also began with synthetic immune-boosting compounds called adjuvants from Steve Reed’s lab at Seattle-based IDRI. Reed and his group had credibility in this department, as they developed an immune-booster purchased by GlaxoSmithKline, and which is used today to increase the effectiveness of its cervical cancer vaccine, known as Cervarix. The long-term vision was to combine Baltimore’s targeted delivery vehicle with Reed’s immune-boosting compounds, to get a high-powered immune response aimed right to the tumor.
Immune Design has gained confidence in the last year after figuring out how to turn Baltimore’s academic prototype into an industrial workhorse. The platform has been given a name, DCVex, and the company believes (based on animal studies) that it can stimulate a powerful and long-lasting group of killer T cells that can hunt down and attack tumors. Immune Design plans to make this lentiviral delivery vector, in combination with a single marker commonly found on tumors, into a product against multiple tumor types, Paya said. He didn’t identify the specific antigen, but said the company will name it publicly in the not-too-distant future. The initial product candidate has been dubbed ID-LV305.
A second product candidate uses one of the company’s synthetic immune-boosting compounds (adjuvants) to stimulate Toll-like receptor 4 (TLR4). This compound, called ID-G305, is supposed to generate T-helper cells of the immune system that are specific to the tumor, while further revving up the other “killer” T cells, and sparking antibody-producing B cells and cells of the innate immune system to provide a multi-pronged attack. These products will be tested separately at first, to determine their safety and efficacy alone, and then perhaps combined into a more potent dual offering, Paya says. The components may also be used in combination with one of the “checkpoint inhibitors” in development by companies such as Bristol-Myers, Merck, and Roche/Genentech (see my coverage from the American Society of Clinical Oncology for more on the Merck and Roche/Genentech drugs and this recent survival data update from Bristol-Myers).
It should be noted that immunology remains a vastly complicated, and still poorly understood field of biology. Researchers don’t know what causes most autoimmune diseases, or have a good idea of how to treat them. One of the big stumbling blocks with cancer immunotherapy is that researchers haven’t traditionally been able to select patients upfront who are most likely to respond to treatment. In the case of Bristol-Myers’s ipilimumab, only a minority of patients respond, yet the drug costs more than $100,000 and comes with some significant side effects. Paya says Immune Design plans to get around this problem by developing a companion diagnostic, based on simple immunohistochemistry techniques, which it believes will select the patients most likely to respond to its immunotherapy.
As followers of the Dendreon story know, it was also tripped up by an expensive and logistically demanding process for the company to be able to stimulate immune cells outside the body and have them shipped back to the patient and re-infused. Immune Design, like many other newer-generation immunotherapy companies, is seeking to sidestep that process by stimulating the desired immune response through a simple injectable drug. In Immune Design’s case, it envisions products that consist of the lentivirus and the specific tumor antigen, or the lentivirus/antigen combo and the immune-boosting adjuvant, Paya says.
