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RNAi Startup SanoGene Moves Brain Cancer Drug into IND-Enabling Studies

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Having recently appointed the first two members of its scientific advisory board, RNAi therapeutics startup SanoGene has begun studies to support an investigational new drug application for its lead drug candidate, a company official told RNAi News last week.

SanoGene was founded to develop and commercialize an expressed RNAi technology developed in the lab of cancer researcher Jasti Rao at the University of Illinois College of Medicine at Peoria, according to company co-founder, President, and interim CEO Caralynn Nowinski.

"The technology itself is an expression-based RNAi system, with the idea [that] targeting multiple genes in a simultaneous fashion [can have] synergistic effects," she said. After a technology-evaluation period following its founding in 2006, SanoGene acquired the exclusive worldwide rights to the intellectual property covering the technology about a year ago.

The company's flagship drug candidate, a locally delivered treatment for glioblastoma multiforme dubbed SG-1311, is designed to inhibit two different proteases that Nowinski said are "particularly over-expressed" in the disease.

She declined to provide specific details about the drug or SanoGene's core technology, but publications by Rao may offer some clues.

In 2004, he and colleagues published data showing that RNAi-based inhibition of matrix metalloproteases-9 and cathepsin B led to a reduction in tumor growth and angiogenesis in both in vitro and in vivo models. That same year, he reported that inhibition of cathepsin B and urokinase-type plasminogen activator receptor led to reduced glioma cell invasion and angiogenesis in vitro and in vivo, as well as a regression of pre-established intracranial tumors.

Last year, Rao published a paper describing how the simultaneous down-regulation of uPAR and MMP-9 induces apoptosis in glioma cells.

But Rao is not affiliated with SanoGene, Nowinski said, describing the company's acquisition of the RNAi technology as "a pure exercise of technology transfer." As such, one of her key tasks over the past 12 months has been to establish SanoGene's scientific team, she said.

Last week, the company announced that it had signed on two cancer researchers, the Translational Genomics Research Institute's Daniel Van Hoff and IDM Pharma's Jeffrey Sherman, to its scientific advisory board (see RNAi News, 5/21/2009).

And while SanoGene remains on the lookout for additional SAB members, it isn't likely to begin building up an in-house research and development team just yet.

"At this point, the idea is [to be] lean and mean, [and we're taking] a much more virtual company approach," Nowinski said. "Much of what we're doing is through academic collaborations and through contract research."

Specifically, SanoGene is working with North Carolina-based contract research and development group Cato Research to advance SG-1311 under a deal the companies inked in 2008. SanoGene was also provided with an undisclosed amount of seed financing by Cato under the arrangement, which was facilitated by Joel Eisner, a principal at Cato venture capital affiliate Cato BioVentures and SanoGene's operations and business development liaison.

Meanwhile, SanoGene's academic collaborations, which remain undisclosed, are primarily focused on evaluating other opportunities for the company's platform technology in order to expand its pipeline, Nowinski noted. She added that cancer remains the firm's focus, and any indications it may end up pursuing will likely be within oncology.

But as a small company, SanoGene is keeping most of its attention on its lead candidate. According to Nowinski, SanoGene has done a limited amount of in vivo work on SG-1311, and the results of those studies suggest the drug is both safe and effective.

Still, "we're really just launching our IND-enabling program," she said, declining to comment on when SG-1311 may be ready to enter the clinic.

At the same time, SanoGene is on the prowl for additional seed money, Nowinski said, although how much the company is looking to raise is not being publicly undisclosed.

As with just about every other company developing RNAi-based therapeutics, SanoGene views industry partnerships as a key source of financing and a vital piece of the drug-development puzzle, she noted. But with the demand for strong data increasing among the big pharma and biotech firms interested in RNAi alliances, Nowinski cautioned that a deal probably isn't just around the corner.

"We think strategic partnering is going to be a key aspect of our commercialization strategy and one that we've been actively pursuing since the earliest point in the company," she said. And while a partnership isn't on the "immediate" horizon, "as we add more value to the technology, I think we'll have an opportunity not too far in the future."

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