In its quest to transform itself from a general technology company into a biotechnology firm, nascent MCU Designs last month won a $213,000 Small Business Innovation Research grant to further develop an automated microfluidics-based cell pharmacology profiling system.
The platform would be the San Diego-based company’s first product targeted toward the biotechnology and, more specifically, drug-discovery markets, despite the fact that the firm’s key personnel have extensive experience in these markets, a company official told CBA News this week.
But MCU Designs may face a major hurdle out of the gate: Its proposed screening platform is based on intellectual property controlled by Caliper Life Sciences. However, MCU said it believes its technology is different enough to avoid any IP disputes.
MCU Designs was founded in 2003 by Alex Okun, a former employee of Axiom Biosciences, which was acquired in 2002 by Sequenom, according to Ilya Okun, Alex’s father and a consultant to MCU Designs.
According to Ilya Okun, MCU’s flagship product was far outside the biotechnology realm: an optical and electronic testing device for detecting minor but potentially dangerous flaws in aluminum oxygen tanks for divers. Okun said that MCU still designs and sells that product today, which has become an “industry standard.”
Recently, however, MCU has decided to revisit its biotechnology roots, Okun said. While at Axiom, the Okuns and others had developed a product dubbed the high-throughput pharmacology system, a microfluidics-based platform for potency profiling of compounds against primarily cellular GPCR targets.
“This system was creating a gradient of the concentration of the compound on the fly,” Okun said. “In the usual screening process you dilute a compound several fold, measure signals at each point – usually six or eight concentration points – and then you plot the data to get potency, like an IC50 or EC50. Our system measured the signal as a function of a steady concentration gradient.”
Despite achieving a few independent validations by pharmaceutical partners, the platform never really gained a foothold in the drug-discovery market. In addition, according to Okun, the company faced some intellectual property battles with then-emerging Caliper, which had filed for patents on a similar microfluidics-based pharmacology profiling system.
“What happened was that our first patent was issued two years before the first patent from Caliper,” Okun said. “But it so happened that they had filed months before us. Then when lawyers started looking at notes, it happened that our notes preceded their notes.”
But when Sequenom acquired Axiom in 2002, Sequenom “didn’t want any litigation,” and presumably wasn’t interested in playing in the cell-based drug-discovery arena, Okun said, so it “basically just gave Caliper the rights to these patents.”
Okun declined to provide details about specific patents that were involved. A Caliper spokesperson told CBA News that it could not comment on the patents without specific numbers.
In any event, Caliper now owns certain aspects of the IP in question, according to Okun. And Caliper, of course, still sells a microfluidics-based pharmacological profiling system – its flagship LabChip technology – which was originally designed for high-throughput biochemical screening but has also more recently been adapted for cell-based assays.
Sequenom “didn’t want any litigation,” and presumably wasn’t interested in playing in the cell-based drug-discovery arena, so it “basically just gave Caliper the rights to these patents.”
Okun said that MCU believes its new product, although based on similar concepts, differs enough from the original patents to avoid any potential IP disputes with Caliper. What’s more, he said, is that Caliper, to his knowledge, doesn’t yet sell a screening platform for concentration gradient types of assays.
“Our new product has quite different IP,” Okun said. “The schema is very different.”
According to Okun, the new system will still assay cells against a concentration gradient of compounds, but it will also measure how signals develop over time. “So our new system will be merging these two dimensions – concentration and time – into one process,” he said. “That will create a 3D picture of the signal propagation within the cell.”
MCU is designing the instrumentation from off-the-shelf components such as CCD cameras, excitation light sources, and optical filters, and will use fluorescence readouts to measure the activation of cellular GPCRs in response to different compound gradients.
“In theory, though it was developed specifically for GPCRs, you could do ion channels with membrane potential sensitive dyes, or any other signal that produces fluorescence,” Okun said. He declined to provide any more details about how the system achieves a compound concentration gradient or time resolution due to the sensitivity of the pending IP. MCU Designs has recently filed for several patents on the new product.
The National Institute of General Medical Sciences awarded MCU Designs a Phase I SBIR grant in September worth approximately $213,000 to further develop the instrumentation. The company won the two-year grant through a proposal it submitted to the National Institutes of Health’s Molecular Libraries Screening Instrumentation program, Okun said.
Gregory Kaler, an MCU employee and former Axiom staffer along with the Okuns, is the principal investigator on the grant.