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U of Rochester Spinout CellTraffix Seeks to Bolster IP Position Through MIT Research

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This article has been updated from a previous version, which incorrectly stated that CellTraffix had an option to non-exclusively license IP resulting from its sponsored research agreement with MIT. In fact, CellTraffix has an option to either exclusively or non-exclusively license the technology. 
 
Researchers from the Massachusetts Institute of Technology and the University of Rochester have demonstrated how technology developed by UR spinout CellTraffix for selectively “trapping” blood cells might be adapted for human applications such as treating metastases, “reprogramming” stem cells, and diagnosing various diseases.
 
In addition, the MIT tech-transfer office has applied for a US patent surrounding the technology enhancements, which CellTraffix has taken an option to license under a sponsored research agreement between the two organizations, a CellTraffix official said last week.
 
CellTraffix, a privately held biotechnology firm located in Rochester, NY, is based on technology developed by Michael King, an associate professor of chemical engineering at UR.
 
The company was founded to commercialize a flow chamber device developed by King for separating, concentrating, or purifying cells by leveraging cell rolling, a biological phenomenon in which cells slow down on their way through blood vessels so they can be trafficked to different parts of the body to be used in, for example, an immune response.
 
The core technology, described in US Patent Application Nos. 20060183223 and 20070178084, specifically uses a class of molecules called selectins that are largely responsible for cell rolling. King developed intellectual property describing a method to coat a biocompatible substance or device with selectins for specific cells, which CellTraffix exclusively licensed from UR.
 
According to King, who remains a UR professor but also serves as chair of CellTraffix’s scientific advisory board, the company was seeking a way to improve the attachment chemistry of the selectin molecules to the surface of the device. Currently, the selectins are attached to the surface using simple physiosorption, which, King said, lasts a couple of days and is adequate for using the devices for in vitro experiments or in small animals such as rats.
 
“We have been testing [the devices] in rats here, which works fine, but the eventual applications – especially the anti-cancer applications – are designed to be longer-term implants,” King told BTW. “We recognized that the attachment methods we were using were probably not the most appropriate techniques.”
 
Therefore, CellTraffix turned to the laboratory of Robert Langer, institute professor of chemical and biomedical engineering at MIT and a well-known expert on tissue engineering and drug delivery. Jeffrey Karp, at the time a postdoc in the Langer lab, took the lead on the project under a sponsored research agreement with CellTraffix that the organizations began in 2006.
 
Karp and colleagues have since developed a biocompatible coating for the glass surface of the device that allows the selectin molecules to stay attached for at least 30 days – the first step toward making the device implantable in humans.
 
“Selectins are so important for physiological and pathological processes such as cancer metastases,” Karp said. “How do cells essentially get from one place in the body to another? People have been really interested in studying this.
 
“Because we’re so interested in the development of a device and not just a scientific endeavor, we looked to the practical side and asked, ‘What are some of the criteria that are going to be necessary for a device?’” Karp added. “And one is that cell rolling be maintained for a substantial period of time. We did this with covalent chemistry, and we maintained a 30-fold enhancement. We could have gone longer as well, but we just stopped after 30 days.”
 
Karp also said that the new technology enables better patterning and orientation of the selectin molecules on the device surface.
 
A full description of the methods developed by Karp and colleagues is published in the Oct. 20 online issue of Langmuir. Because the sponsored research agreement was with MIT, its Technology Licensing Office took the lead in patenting Karp and colleagues’ innovation.
 
Karp, who is now an instructor in medicine and health sciences and technology at the Harvard Medical School Brigham and Women’s Hospital, continues to collaborate with the Langer lab on the project as an MIT affiliate professor, and in January 2008 will begin the second year of the two-year sponsored research agreement, “so we’ll continue to generate IP and write papers based on what we find in the lab,” which MIT will continue to manage, he said.
 
Building an IP Position
 
The new patent applications, currently under review by the US Patent and Trademark Office, have not yet been published in the USPTO database. According to Doug Naab, vice president of business development and licensing at CellTraffix, the company has an option to either exclusively or non-exclusively license any IP that results from the MIT research, and will likely exercise that option in the coming weeks.
 
“It’s sort of an automatic – it’s built into the sponsored research,” Naab said. “It’s just sort of a key you need to turn. It’s a pretty straightforward, standard licensing agreement, but this is something that we are going to pursue. It will, in some way, become part of our product mix, because the adhesion of the molecules covalently to the surface is important.”
 
Naab declined to disclose financial details of the sponsored research agreement. Calls to the MIT TLO were not returned in time for this publication.
 
MIT reserves the right to license Karp’s invention to parties besides CellTraffix, but it would likely be of little use to the university on its own since it is based on the CellTraffix core technology.
 

“It will, in some way, become part of our product mix, because the adhesion of the molecules covalently to the surface is important.”

Naab said that non-exclusivity, or the “slicing and dicing” of patents, is simply the reality of licensing university IP. “If we do elect a non-exclusive license, then theoretically they could license to other people,” he said. “The issue is that we have surrounding patents, so we would probably be in a position to block people … or license our technology out, which would be another step along the path [to commercialization]. But [licensing this] will provide both a block and enabler to people we choose to eventually license to.”
 
In the meantime, CellTraffix is still sorting out its IP position regarding the original technology that it exclusively licensed from UR. Naab and King said that the patents have yet to be officially awarded, but that they have received a notice of allowance on at least one of the patent applications.
 
“We have a pretty good position in terms of the patents and applications,” Naab said. “We’re trying to build a sufficient magnitude of IP in this area involving patents and know-how. We also have our own scientists in house doing work, and are near to establishing our own lab space here in Rochester to do some of the development work and secure some patents in that area as well.”
 
King said that the first product from CellTraffix would likely be an in vitro research kit for the enrichment and purification of specific cell populations, which would be based solely on the UR patents. “We’re really seeing a lot of publications that describe very effective, rapid enrichment of stem cells from blood,” King said. “I probably can’t say too much more about the specific cell types we would target, but you can guess it will be related to stem cells and the like.”
 
This product would hopefully hit the market before the end of next year, King said.
 
CellTraffix’s “homerun” product, King added, would be a device that could be implanted in humans for filtering and neutralizing cancer cells from the bloodstream, which would require the MIT IP.
 
Other potential applications for the device include trafficking or “reprogramming” stem cells and diagnosing a variety of diseases based on the isolation of specific cells from the bloodstream.
 
CellTraffix has so far received an undisclosed amount of funding from angel investors, which is “sufficient” for the company to tackle the development of its first device, Naab said. The company is currently seeking additional funding for its future projects, he added.

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