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: [[ticker:BIIB]]) talked about yesterday with investors in its annual R&D day.
