Integrated Diagnostics is best known as the Seattle startup looking to carry out Lee Hood’s vision of spotting cancer in a drop of blood. But the company is moving ahead on another bold vision, in which it is seeking to disrupt the world of molecular imaging.
InDi is announcing today it has set up a new division, called InDi Imaging, in Southern California near the Caltech lab of co-founder Jim Heath. The new division, which CEO Al Luderer says could be eventually spun out into an independent company, will be led by veteran executive Norm Hardman, a former president and CEO of Amicus Therapeutics (NASDAQ: FOLD) and chief operating officer of Onyx Pharmaceuticals (NASDAQ: ONXX). InDi Imaging will also be advised by UCLA professor Michael Phelps, a pioneer of positron emission tomography (PET) scanning, one of the workhorse technologies of modern medical imaging.
The idea here is to basically swap small molecules for the large molecules now used in the imaging world. Today’s PET scanners depend on using genetically engineered antibodies that are attached to a radioactive tracer, which makes it possible for imaging instruments to construct a 3-D image of what’s happening inside the body. While antibodies are good at specifically hitting certain molecular targets of interest, they are also bulky large molecules that can’t hit all molecular structures in and around cells, they can cause immune reactions, they need to be carefully handled to remain stable, and they are difficult and expensive to manufacture at large scale.
InDi says it can make small-molecule peptides, through synthetic chemistry techniques, that are cheaper and easier to manufacture in large volumes. These small molecules should also be able to precisely bind with just as many biological targets or more, while cutting down on immune-system reactions, Luderer says.
“This allows you to do things you couldn’t do before,” Luderer says. “It will work like an antibody, but without the drawbacks.” He adds: “This is like going from black and white with no sound to Technicolor and surround sound. It’s big.”
It’s taken the InDi team a couple of years to figure out the strategy for how to best use this technology in the business world, Luderer says. It considered developing it as a replacement for proteins used in scientific instruments known as mass spectrometers, and then as a replacement in the antibody kits currently prepared by medical imaging suppliers. But essentially those ideas were dismissed as too small. “It became clear that’s not where the value proposition is,” Luderer says.
InDi’s plan for creating its own PET imaging probes leans in part on the “click chemistry” work of Nobel laureate Barry Sharpless and colleagues at The Scripps Research Institute in San Diego, as well as Heath and his team at Caltech. The way it works, the chemists synthesize a peptide that’s 15 to 16 amino acids long, and that can be built to bind specifically with all kinds of conventional biological targets, such as the prostate-specific antigen (PSA), the HER2 protein that contributes to tumor growth, or any specific portions of a target of interest, Luderer says.
The research is still very much in the early stages, probably 12 to 24 months away from its first clinical trials, he says. But InDi has gained confidence in the technology in recent months after using this chemistry platform to detect mouse tumors.
The technology here is quite different from what InDi uses in its core diagnostic business, and it is also on quite different financial and regulatory paths. Essentially, the diagnostic side of InDi is on track to develop its first commercial product, a blood test for lung cancer, by the end of March 2013. The InDi diagnostics business will be run out of a centralized CLIA-certified lab, but it won’t need to spend the time and money to get an FDA approval like a pharmaceutical company would.
The imaging side of the business, however, is on a track that’s more drug-like, in which the company will need to design clinical trials to help it win FDA clearance to start marketing the chemistry for medical imaging purposes. Once the InDi Imaging business plan takes shape this fall, the parent company should be able to lay the groundwork for a spinout and separate Series A financing, Luderer says.
Luderer says he sees potential opportunity in selling InDi Imaging technology to all kinds of physicians who use imaging. But pharmaceutical companies are another potential type of customer. Drug companies have been showing more interest lately in using advanced imaging technologies to help improve their success rate in the development of new drugs—something that Weston, MA-based Biogen Idec (NASDAQ: BIIB) talked about yesterday with investors in its annual R&D day.