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this program would wither in academia, and it really needed private investment dollars and a business focus and discipline to really move forward into a useable product. As he says, getting the team in place was vital.
Reed started out as the founding CEO, and originally agreed to spend 80 percent of his time team with the startup, devoting the rest to his research and administrative duties at IDRI. This makes him an extremely busy guy, especially since he’s traveling the world to global health conferences, and he’s frequently invited by politicians to offer advice on vaccine policies. In fact, Reed just finished co-authoring a strategy paper requested by President Obama on this very question, in the wake of the H1N1 outbreak from a year ago.
So, assembling the right 25-person roster was critical in the early days. At the highest levels, Reed is getting help from Bruce Carter, a part-time executive chairman of the board, a local biotech pioneer who has a golden Rolodex from his many years as CEO of Seattle-based ZymoGenetics (NASDAQ: ZGEN). Tom Dubensky, a former R&D leader at Anza Therapeutics and Onyx Pharmaceuticals, was brought in as chief scientific officer. The newest recruit is chief business officer Sammy Farah, formerly a scientific liaison at Merck and a member of the biotech investing team at Versant Ventures—one of Immune Design’s backers.
Immune Design isn’t saying a lot yet about the data it has gathered to support its founding idea. For now, the GLA adjuvant and the lentiviral vector system from Caltech are being developed on parallel tracks, with an eye toward eventually merging the delivery capability and the increased potency. So far, the GLA adjuvant has been added to a standard flu vaccine, and run through a clinical trial in people over the age of 65, who often don’t mount a strong enough response to flu vaccine to fight off the pathogen. That trial wasn’t statistically designed to prove the adjuvant-boosted vaccine works better, but it did demonstrate the adjuvant was safe and able to trigger an immune response at a couple different doses.
That study was an important bit of proof for the concept of the adjuvant, Reed says. The trial laid the groundwork for Immune Design’s next step, which is to incorporate the adjuvant into an internally-developed vaccine for an undisclosed infectious disease. The flu vaccine trial was critical to earning the confidence of investors to ante up in a second round, and it has sparked dialogue with Big Pharma partners that have the money to speed up the development process.
Immune Design is currently in “advanced negotiations” with a Big Pharma partner that wants a license to incorporate the GLA adjuvant into vaccines for specific uses, Reed says. He said he hopes to announce that deal soon.
Further back in the pipeline, Immune Design is working to reproducibly make the lentiviral vector system at commercial scale. That work has been progressing well enough that it should be poised to enter its first clinical trial in 2011, Reed says.
The plan is to use that lentiviral system to specifically stimulate dendritic cells, a certain cell type made famous by Seattle-based Dendreon (NASDAQ: DNDN). While Dendreon made headlines this year with the first-ever FDA approved drug that actively stimulates the immune system against cancer, biotech entrepreneurs like Reed see ways to advance the field much further. The Dendreon process requires the dendritic cells be stimulated outside the body, and re-infused into the patient after they have been stimulated to fight prostate cancer cells. Immune Design hopes to create a simpler product, that’s essentially a targeted lentiviral vector, combined with a protein marker on cancer cells, and an adjuvant for extra immune-stimulating kick. This could be formed into an injectable therapy, without the hassle of blood draws, and re-infusions.
Certainly, Immune Design benefitted from some good timing. The H1N1 global pandemic last year created a real sense of urgency among governments and Big Pharma companies to find a way to stockpile vaccines for a worst-case scenario. That instantly thrust Reed and his team into top policy circles, because their adjuvants could be a cost-effective strategy to inoculate many more people than health authorities can today. Adding adjuvants to the existing vaccine manufacturing processes could greatly increase potency, and allow officials to use much lower doses. That means that many more people could get immunized without forcing Big Pharma companies to spend the time and money on building new vaccine factories.
The increased urgency helped Immune Design secure a $3 million biodefense contract to do some further testing of its adjuvant, the kind of “non-dilutive” financing that venture capitalists like to see. Reed, who just turned 60, says the company’s progress reminds him of those early days at Corixa, which went on to do multiple partnerships and an IPO.
“I’m really excited about this company,” Reed says. “We have a great team, and great technology.”