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Quark Taps Glaucoma Drug to Be Its First Novel RNAi Agent, CEO Speaks Out on Silence

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Quark Pharmaceuticals has sharpened its focus on glaucoma, moving to the front of its preclinical pipeline an siRNA-based drug candidate designed to protect ocular neurons from the damage that characterizes the disease, a company official told RNAi News this week.
 
Although Quark had previously disclosed its interest in glaucoma, the program had appeared to be less advanced than others under development and is not currently noted on the company’s website. But now the indication has jumped a few places in the queue.
 
The pipeline changeup also highlights a sore spot between Quark and licensing partner Silence Therapeutics. According to Quark President and CEO Danny Zurr, the structure of the glaucoma treatment, called IGNi, will be proprietary and not fall under any of the intellectual property the company had previously licensed from Alnylam Pharmaceuticals and Silence Therapeutics.
 
The two Quark drugs currently in the clinic, as well as a product candidate that recently received clearance to enter clinical testing, all fall under that IP — a situation that Zurr said has resulted in Silence at times overstating its role in Quark’s research and development efforts.
 
“Much to my dismay, Silence … is trying to present to the public that [our clinical candidates are] their products,” something that Alnylam has not done, he said. A forthcoming announcement, however, is expected to help clarify the situation and provide details on Quark’s novel siRNAs.
  
According to Zurr, the glaucoma program stems from a longstanding interest the company has had in neuroprotection, which includes a collaboration between Quark and Rutgers University on RNAi-based treatments for spinal cord injury. Work in this area yielded a drug that appears capable of preventing the retinal ganglion cell death believed to cause vision loss in glaucoma patients.
 
Current glaucoma treatments are designed to reduce intraocular pressure, which can slow the progression of the disease, but don’t address the loss of ganglion cells, Zurr said.As such, “there is an unmet medical need [in trying to] preserve and protect those … cells,” he said.
 
Quark has been quick to move forward on IGNi, putting it virtually alongside its most advanced preclinical siRNA candidate, AHLi-11, which is designed to treat acute hearing loss associated with acoustic trauma or ototoxic drugs, Zurr said.
 
He declined to offer a timeline for when either of the drugs might enter the clinic. However, he said in an April press release that Quark anticipates having five drug candidates in human testing before the end of 2008.
 
Quark already has in the clinic the phase I wet age-related macular degeneration drug RTP801i-14, which Quark licensed to Pfizer in 2006 (see RNAi News, 9/28/2006), and AKIi-5, a phase I preventative for acute renal failure in patients undergoing major cardiac surgery (see RNAi News, 11/22/2007).
 
Last month, the company announced that the US Food and Drug Administration had approved its investigational new drug application for DGFi, an siRNA designed to prevent and/or treat delayed graft function in kidney transplant patients (see RNAi News, 6/26/2008).
 
Sounding Off on Silence
 
In advancing DGFi ahead of most of its other preclinical programs, Quark has taken a major step towards establishing itself as an independent RNAi drug developer that owes nothing to peers in the field with established IP estates.
 
Increased attention to its proprietary molecules is also expected to prevent the kind of misunderstanding that occurred between Quark and Silence.
 

Silence is “trying to create the image that [our pipeline] is their pipeline. If you open [their] website, all of a sudden you see our pipeline.”

“All the products we have in the clinic now … are all based on [IP] licenses we took from Alnylam and Silence,” Zurr said this week. But this is where those companies’ involvement in Quark’s R&D efforts ends, he stressed.
 
“We took licenses on certain structures of siRNAs from these two companies, period,” he said. The drugs are designed against “our targets and [are under] our development.”
 
Still, Silence is “trying to create the image that [our pipeline] is their pipeline,” Zurr said. “If you open [their] website, all of a sudden you see our pipeline.”
 
Silence CEO Jeff Vick told RNAi News this week, however, that Quark has “no current concerns” with its statements or pipeline chart.
 
“It was a misunderstanding in how press releases were written, [and] … as soon as he brought that to our attention, we made sure the wording was fixed” in future announcements, he said. “This is old history … [that] goes back to before I joined the company” in 2007 (see RNAi News, 8/2/2007).
 
“When last I spoke with [Zurr], he said he’s happy with our statements,” Vick added. “When I present the pipeline, I’m always very clear [in saying] that these are Quark’s products.”
 
Following Vick’s interview with RNAi News, Silence announced that he had resigned from the company for personal reasons.
 
A Quark spokeswoman, however, said that the discussions between Zurr and Vick over the issue have resulted in a “compromise” that has improved the situation but not rectified it completely. She did not elaborate.
 
IPO Touch and Go
 
After pulling the plug on a proposed initial public offering in the US last summer amid unfavorable market conditions and an unwillingness to cut the offerings’ proposed share price (see RNAi News, 8/2/2007), Quark began eyeing 2008 as the year it would go public.
 
But by late 2007, plans for an IPO were put on hold indefinitely. This week, Zurr confirmed that Quark is still holding off on any kind of public offering since “the IPO market for biotech companies in the United States is currently non-existent.
 
“Even if we’d like to go for an IPO, this is not the right time,” he said. But having just closed a $27 million private financing round (see RNAi News, 4/10/2008), and poised to receive additional milestones from its partner Pfizer, “we are sitting on a very nice cushion … so there is no real need for additional money at the moment,” he added.
 
But Zurr didn’t completely close the door on a possible IPO.
 
“You normally go public because you need additional cash to move forward, [and while] … there is no immediate need now after the last financial round … the moment there is an opening, whether its in the United States or another market, we will certainly seize the opportunity,” he said.

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