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Intradigm Eyes Cancer for First Clinical Candidate; Will Go It Alone if Necessary

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Intradigm has found its lead RNAi-based drug candidate in ICS-283, and while the drug’s target — the VEGF pathway — is nothing new in the RNAi field, the company is likely to pursue a novel indication for the compound.

John Spears, Intradigm’s CEO, has said in the past that its anti-VEGF agent could have potential in ocular, neovascular, and oncologic indications (see RNAi News, 2/27/2004), but it appears that the company is strongly leaning towards cancer, specifically colorectal cancer, and that it is not shy about developing the drug on its own.

Although other RNAi drug firms have expressed an interest in oncology, and some even have basic research programs ongoing in that area, Intradigm would be the first to jump right in.

“It uses two levels of selectivity,” he told RNAi News on the sidelines of the GeneExpression Systems’ RNAi-2004 meeting this week in Waltham, Mass. “One is the neovasculature targeting selectivity, and the other is the VEGF pathway-inhibition targeting activity.”

Given the potential for anti-angiogenics in combating cancer, Intradigm is strongly considering tackling oncology with its drug. “We’re pretty sure cancer is the best place to go first into the clinic,” Woodle said, with expansion into other “diseases of angiogenesis” possible down the road.

Woodle said that Intradigm is currently talking with possible partners for ICS-283, but noted that the company is willing to go ahead with clinical development of the drug if the right collaborator is not found.

“We may well identify a good partnership, but to get into a phase I study in oncology is probably about 30 patients or so — it’s not the multi-million dollar clinical development that occurs in a lot of situations,” he said. As such, he said he believes Intradigm is more than capable of handling the development effort alone, adding that phase II studies in cancer also “can be done in a relatively small group of patients.”

“In oncology, it’s not so difficult to go forward,” Woodle added. “John [Spears] and myself, we have a lot of experience in oncology drug development aspects. We can find a good CRO to work with us, find many academic oncology groups to put together the clinical work, and take it forward.”

Woodle said that the company expects to initiate the first clinical study of ICS-283 in treatment-refractory patients with various solid tumors, and is targeting an investigational new drug application filing in mid-2005.

Afterward, a decision would be made on which type of cancer Intradigm would specifically go after with its drug. Woodle said that the company is currently “assembling a good clinical team to help us identify what should be the first” indication. But as of right now, colorectal cancer is an attractive possibility, in part because of the success of another company’s drug.

In February, the US Food and Drug Administration approved Genentech’s Avastin, an antibody-based drug that targets VEGF, as a first-line treatment for colon cancer in combination with chemotherapy.

To Woodle, the approval of Avastin “helps validate that a patient population can benefit from VEGF pathway [targeting drugs]. Yet, that antibody is not completely eradicating disease in that patient population,” he said.

Avastin “is very good to take care of existing protein — it binds the protein,” Woodle said. “We think that an siRNA inhibitor that is able to stop production of the VEGF pathway protein would make a very nice fit with an approved agent that can bind to existing protein.

“That’s the way cancer therapy often is: Bring on a new agent to help the other agents do their job even better,” he added.

Intradigm is likely to have made a decision on whether colorectal cancer will be the first indication pursued for ICS-283 sometime this summer, Woodle said, and that choice will be reflected in the patients selected for the initial clinical trial.

He said that since phase I trials evaluate safety (although cancer drug studies often begin with phase I/II trials), the drug would probably be tested first as a monotherapy. The possibility of testing ICS-283 in combination with Avastin — or any other drug, for that matter — is something that will be determined later on.

Getting There

In preparation for the IND filing, Intradigm is looking for a contract manufacturer for ICS-283, Woodle said. Although, “some of [the manufacturing] may be done within Intradigm, the majority of it will be [done by] … a contractor,” he said.

Intradigm is also working with a regulatory consulting group to help map out the company’s strategy for dealing with regulatory hurdles and prepare for its pre-IND meeting with the FDA, Woodle said. Time with the agency has not been scheduled, but a pre-IND sit-down could occur as soon as this summer, he added.

As for how Intradigm will afford all of this, Spears told RNAi News in a telephone interview that the company is in the process of a Series C round of financing, through which he hopes to raise between $10 million and $15 million.

He noted that these funds should be more than enough to fund Intradigm (a company of about 12 employees) through a phase I trial of ICS-283, which he estimates will cost between $1 million and $1.5 million.

Spears declined to speculate on when the financing might close.

— DM

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