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Integrated Diagnostics Launches Spin-out InDi Molecular to Commercialize PCC Reagents

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Integrated Diagnostics said this week that it has spun out its protein catalyzed capture agent business into a new firm, InDi Molecular.

The new outfit, which aims to market its PCC agents as alternatives to antibodies for use in the in vivo imaging, therapeutic, in vitro diagnostic, and biological tools markets, launched with $1.5 million in seed funding from InterWest Partners and company co-founders.

With the launch of InDi Molecular as a separate entity, InDi has cleared the way for a new round of financing to support the commercial launch of its proteomic lung cancer diagnostic, Albert Luderer – who will serve as CEO of both firms – told ProteoMonitor.

Launch of the test remains scheduled for 2013, Luderer said, adding that "all development [of the test] is complete and locked down. So we are very close."

InDi Molecular's PCC reagents use click chemistry combined with pairs of random peptide libraries – one containing acetylene functionalities and the other containing azide groups – to create affinity reagents to given proteins. Target proteins are screened against these libraries to find peptides that bind them, and when these peptides bind, the protein epitope acts as a catalytic point for the acetylene- and azide-containing peptides, which then link together via click chemistry, forming multi-peptide, protein-binding constructs that can then be pulled down and identified.

The company licensed the PCC technology from the California Institute of Technology, where it was developed by CalTech professor and InDi Co-founder Jim Heath (PM 10/28/2011).

InDi formed a separate division called InDi Imaging to house the PCC business in 2012 with plans to spin it out into a separate company that same year (PM 6/15/2012). These plans, however, were delayed by a year due to difficulties in lining up the needed financing, Luderer told ProteoMonitor this week.

In fact, he noted, the firm was ultimately unable to secure the roughly $10 million it hoped to raise to support the launch, having instead to rely on the $1.5 million provided by InterWest and company founders including Luderer, Heath, Lee Hood, and University of California, Los Angeles, professor and inventor of PET imaging, Michael Phelps.

Luderer, who previously served as president and CEO of BioTrove, now part of Life Technologies, said the company received "a lot of interest" from venture capital funds, but "had no takers." In part, he said, this was due to the fact that InDi had not had time to develop the PCC technology sufficiently. He suggested as well that the technology's novelty and the fact that with it the company aims to supplant a well-established, widely used reagent in monoclonal antibodies, also likely led to investor reluctance.

"When you've been dealing with monoclonal antibodies for 25 [or] 30 years, and they have been very successful, [moving to PCCs] is a very large shift in thinking," he said. "You are getting compared to something that has a strong base and thousands of different examples [of utility], and so you need to be able to generate enough examples of performance and applications that you can convince someone that an investment is appropriate."

With this in mind, InDi Molecular is shifting from its previous strategy, which was focused on applying the reagents to PET imaging and therapeutics, to a focus on demonstrating their usefulness as biological research tools and in in vitro diagnostics. While work remains ongoing on the imaging and therapeutics front, "we have really reached out to the in vitro diagnostic and biological tool companies to enter discussions about whether there would be interest in partnering and potentially developing products in those spaces," Luderer said.

According to Luderer, PCCs have several potential advantages over monoclonal antibodies including better specificity and the ability to target regions of proteins not accessible to monoclonals. He noted that while the binding affinities of the company's initial reagents were not quite as good as in monoclonals, it has since developed PCCs that match and in some cases exceed antibody affinities.

The bulk of the company's in vitro diagnostic work to date has focused on PCCs for detection of HIV, Luderer said. In 2011, InDi and Heath's lab at CalTech received $500,000 from the Bill and Melinda Gates Foundation to develop PCCs to HIV (PM 12/23/2011), and through this work have developed a three-PCC cocktail for HIV detection that is currently in field trials in India.

This cocktail has been shown to be stable for months at 60 degrees Celsius, Luderer said, noting that the reagents' stability offer another potential advantage compared to traditional antibodies.

Also potentially advantageous – particularly for infectious disease work – is the ability to target PCCs to any desired region of a protein, Luderer said.

"In the infectious disease area, where you are concerned about mutation frequency, we have methodologies that allow us to target regions that are highly conserved, to build universal reagents that should work independently of how the rest of the virus is mutated," he said.

From start to finish, development of a fully-characterized PCC suitable for use in an in vitro diagnostic, such as the HIV product, currently takes from six to nine months and costs several hundred thousands of dollars, Luderer said. He added that the company believed that in mass production they could prove significantly less expensive than monoclonals.

With its current funding, InDi Molecular has resources for five to six quarters, Luderer said, in which time it aims to continue technical development of the PCC reagents while trying to establish partnerships with in vitro diagnostic and tool firms. The company is aiming for a series A funding sometime in 2014, he added.

It plans to continue work on the PET imaging side of the business, as well, he said, focusing in particular on reagents for targeting the protein VEGF with the goal of gathering data to apply for an investigational device exemption that would allow for testing in humans.

Any in-human PCC imaging trials, however, will likely wait until the company has found a partner for those efforts, Luderer said. It currently has work ongoing in mouse models.

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