Though it’s only a month into a strategic drug development agreement between ImQuest Pharmaceuticals Inc. and Samjin Pharmaceutical Co. Ltd., the alliance already has yielded its first licensing deal.

ImQuest, which has a right to first refusal for molecules developed by Seoul, South Korea-based Samjin, picked up Samjin’s entire pyrimidinedione series of compounds in development to treat HIV, including a lead molecule, IQP-0410, which is being investigated as a front-line therapy for HIV infection. Financial terms of the deal were not disclosed.

This is "a series of compounds with some highly significant anti-HIV activity," said Robert Buckheit, president and chief scientific officer of Frederick, Md.-based ImQuest, and a "very interesting biological profile in that these compounds have two mechanisms of action."

Pyrimidinediones are designed to work both by inhibiting reverse transcriptase, the mode of action seen with New York-based Bristol-Myers Squibb Co.’s Sustiva (efavirenz), and by inhibiting viral entry into target cells, a mechanism similar to Fuzeon (enfuvirtide). Fuzeon was co-developed by Trimeris Inc., of Morrisville, N.C., and Basel, Switzerland-based F. Hoffmann-La Roche Ltd.

"In one small molecule, we actually have anti-HIV activity that’s essentially at a level equivalent to a combination of Sustiva plus Fuzeon," Buckheit said.

The dual mechanism of pyrimidinediones could help simplify the treatment regimen for HIV patients, but unlike some combination products, "we don’t have to worry about two separate toxicity profiles or interactions," Buckheit told BioWorld Today. He added that in a recently completed acute toxicity study of IQP-0410, "we were able to dose up to 2,000 mg/kg per day, and we did not see any adverse reactions or signs of toxicity."

ImQuest anticipates filing an investigational new drug application for IQP-0410 early in the fourth quarter, with clinical trials to begin in 2007.

Under the terms of the licensing agreement with Samjin, ImQuest agreed to provide preclinical and drug development support for the 68 molecules included in the pyrimidinedione series. The company already has identified a compound for potential development as a topical HIV microbicide for use in the developing world.

"So that could certainly be our focus for another 2007 trial," Buckheit said, adding that the company is in discussions to partner that product.

For IQP-0410, the plan is for ImQuest to complete Phase I and possibly Phase II before considering out-licensing or partnership opportunities. However, "if the data look really good, that might be enticing enough to make us jump into a Phase III study on our own," he said.

"One of the things we’re trying to do is to really focus on what we’d call novel, or first-in-class types of inhibitors," he said. ImQuest’s HIV program "is not trying to compete in the existing classes of protease inhibitors or the [reverse transcriptase] inhibitors. We’re really looking for things that can advance the field into new areas."

ImQuest was founded last fall as a drug development unit under the larger ImQuest Life Sciences Holdings Co., which also includes service provider ImQuest BioSciences, a unit that does early development and preclinical work for pharmaceutical and biotech companies in the areas of infection, cancer and immunoassays.

As part of that arrangement, the pharmaceuticals unit is intended to act as "a vehicle to take compounds that are very attractive and help move them into clinical trials," Buckheit said. "The goal is really to bridge the gap" between the preclinical development of ImQuest BioSciences and late-stage clinical trials.

ImQuest is looking to build a multiple-product pipeline through its continued work with Samjin, which could add potential programs in hepatitis C, influenza or drug-resistant bacteria. They also want to negotiate licensing deals with other firms in the areas of infection, cancer and inflammation.

The company has 12 employees, and "our game plan is to run as virtually as we possibly can for as long as we can," Buckheit said.

Up to this point, ImQuest’s funding has come primarily from angel investors, though the company likely will start to seek additional funding, through either venture capital investments or partnerships, as it begins moving its first products into clinical trials.

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