NeoClone, an 8-year-old antibody manufacturer, said last week that it has received a $750,000 Phase II Small Business Innovation Research contract from the National Cancer Institute to continue developing an array-based ovarian cancer screening tool.
The Madison, Wis.-based company received a $100,000 Phase I SBIR in 2004 to initiate the work, and now the company plans to add hardware and one researcher to assist with the project. Additionally, the firm is now open to more array-related projects, according to a company official.
NeoClone CEO Deven McGlenn told BioArray News last week that the ovarian cancer test under development is the company’ first experience with arrays, but that it now sees an opportunity for greater activity in that market.
“The beauty of arrays is that you can screen a lot of different biomarkers efficiently with a relatively small amount of patient sample,” he said. "That’s why we believe that we think this technology can have a huge impact on the marketplace,” McGlenn said.
Until it began developing the array-based test, NeoClone had strictly been an antibody manufacturer, selling antibodies to biotech and pharmaceutical companies. Then it was contacted by Early Detection Research Network researchers at NCI to assist in developing a high-throughput ovarian cancer screening tool, although the first phase of the work with NCI was to test the quality of its antibodies on arrays, which were printed by fellow Madisonian GenTel Biosciences.
McGlenn said that the work with EDRN has been funded through contracts, rather than grants. Therefore NeoClone must produce results commensurate with the project in order to receive all of the funding for the phase of the project.
“Our goal for [the first] effort was just to show that we could make really good antibodies. We made a wide range of antibodies against three separate targets, and then we developed capture enzyme-linked immunosorbent assays and then we compared performance of capture ELISAs against currently available diagnostics,” he explained.
With the new funding, NeoClone will validate the targets on arrays with the ultimate goal of creating a 50-antibody multiplex array-based assay that NCI will use to screen a large number of samples with the hope of detecting early-stage cancer. GenTel will print the arrays for the second phase of the project as a subcontractor.
McGlenn said that in the future there is the possibility that NeoClone could move towards US Food and Drug Administration-approved diagnostics based on the assay, “but of course that’s years off.”
He said that more pressing is the creation of the screening tool, and that NeoClone and its partners “have a reasonably good chance” to have some portion of the 50 antibodies well-characterized enough for use research tool “by the latter part of 2008.”
McGlenn said that NeoClone will use the $750,000 contract to pay for a high-end scanner and hire another staffer. He said that the award is “just part of [NeoClone’s] revenue stream” and that the privately owned company has “done custom antibody work since day one, so we generate a fair amount of revenue.”
NeoClone’s partners at EDRN could not be reached for comment.
While NeoClone is excited by the opportunities of the array market, McGlenn was quick to point out that the firm has no interested in acquiring or generating array technology itself. Instead it has chosen to work with GenTel to create the arrays, sticking to its role as a content provider, one it will maintain as it moves forward with other possible array-related projects.
”To the degree that we have other partners that would want to work on microarray projects then of course we are very interested.”
“You have two components to any diagnostic test: You’ve got the content and then some way of delivering the content,” said McGlenn. “Our focus is strictly the development, so for this development we are subcontracting our array work to GenTel,” he said.
Robert Negm, GenTel’s vice president of business development, told BioArray News this week that NeoClone’s approach to developing monoclonal antibodies “overlaps with our expertise in multiplex immunoassay development.”
He said that privately owned GenTel is arraying NeoClone’s antibodies on its ultra-thick nitrocellulose slides through the services wing of its business, which accounts for roughly half of its annual revenues.
“One part of our business makes immunoassays that go into boxes that you can buy off the shelf. This falls under our services business. They provide us their reagents, and we do the tests to see which are truly specific and don't cross-talk with an antigen or another antibody,” he said.
Negm said that “this is a very routine part” of GenTel’s business. “When people come to us and we do it, they own the assays themselves. We keep a hands-off approach to the marketplace so that people can feel comfortable in using the assays as they wish. In this scenario we are an OEM provider,” he said.
Overall, Negm said that the NeoClone partnership is valuable to GenTel in terms of promoting its technology and capabilities as an assay developer. “The nice part about the NeoClone contract with NCI is that we are pretty solid assay developers right now, and so we are not a protein reagent company but NeoClone is,” he said.
Negm said that whether the partnership will result in “a high-throughput screening tool remains to be seen,” but that he can envision NCI and NeoClone achieving that final goal.
Both GenTel and NeoClone’s technologies cater to the biotech and pharmaceutical industries, and so it is possible that their interests could overlap in the future. McGlenn said that many of NeoClone’s customers use microarrays as an R&D tool and that he believes that there may be greater market opportunities for NeoClone in the array space in the future.
“To the degree that we have other partners that would want to work on microarray projects then of course we are very interested,” he added.