INNOVATION: DEVELOPING NEW DRUGS AND NEW DRUG DELIVERY SYSTEMS IN LAWRENCE
| 2014 Q4 | story by LIZ WESLANDER    | photos by STEVEN HERTZOG |
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Deciphera lab

Hidden in plain sight among unassuming buildings in downtown and north Lawrence are two high-tech biotechnology companies that are working on innovative cancer treatments that could be available on the market in the future.

CritiTech, a Lawrence born-and-bred drug development company, operates both its labs and business offices in a space along E. 1450 Rd just north of downtown. Deciphera, with its business headquarters in Boston, Mass. has biology and chemistry labs located on the 600 block of Massachusetts Street- right across from the Free State Brewery.

Daniel Flynn, the CSO and Founder of Deciphera Pharmaceuticals, received his Ph.D. in medicinal chemistry at the University of Kansas. Flynn said that when he established Deciphera in 2003, he could have located the company’s research labs anywhere in the country. He chose Lawrence.

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CritiTech lab equipment

“I wasn’t wooed here, I came voluntarily.” Flynn said. “Even back 10 years ago there was a beginning of a desire from the thought leaders of the city wanting to bring Lawrence forward as a regional biotech hub. I wanted to be a part of that.”

Deciphera’s labs were originally located at KU’s Life Science Research Laboratories, at 1501 Wakarusa. In 2011, they moved to their downtown location.

“It’s surprising that we would have a research lab above Chico’s and the Gap, but we worked with city commission to make them comfortable with being us downtown,” Flynn said. “Lawrence is a wonderful town to work in. At least a third of our hires have been KU graduates or KU-affiliated. We have had no problem tapping into the human resources that have been available here.”

Deciphera specializes in developing cancer-fighting pharmaceuticals that use a technology called kinase inhibitors. Kinases are enzymes that transmit signals within cells to help the cells function. Kinase have “switch” mechanisms that allow the enzymes to “turn on” to perform its function, and “turn off” when not needed. Mutations in a kinase switch can cause a kinase to remain on continually, which can cause a cell to become cancerous. Kinase inhibitors work by targeting the faulty kinase switch, which cuts off the ability of tumor cells to thrive and spread.

“Our approach to cancer is not the standard chemotherapy, which is designed to kill any cell whether it is cancer or not,” Flynn said. “Kinase inhibiters are targeted therapeutics – they go into a cell and target the runaway kinase. The side-effect profile is much more favorable this way.”

Flynn said that Deciphera has spent the past five to six years focusing on researching and developing its specialized kinase inhibitor technology platform to produce drug candidates. It now has five drug candidates at various stages development that utilize the company’s technology. The ultimate goal is to advance these candidates into human clinical trials so that they may ultimately be available on the market to treat cancer patients. Clinical trials measure outcomes and assess the safety and effectiveness of a new drug or combination of drugs. New pharmaceuticals undergo three phases of clinical trials before being approved for marketing. Deciphera currently has three drug candidates in Phase I clinical trials, including one that is being developed in partnership with pharmaceutical giant Eli Lily.

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Dechipera, front row left to right: Cynthia Leary, Anjanette Wilhelm & Daniel Flynn. Back row: Mike Kauffman, Bryan Smith, Linda Martin, Susan McElwain & John Lord

Flynn said that partnering with Eli Lily in the early stages of clinical trials was in Deciphera’s best interest for this particular drug. However, the company plans to conduct Phase I trials for its other drug platforms in its Lawrence labs when possible. It will then seek strategic partnerships with pharmaceutical companies once the drugs have advanced to later phases.

“Our design is to finish Phase I clinical trials in-house,” Flynn said. “It is all about risk and reward. If we have internal phase-one data that looks good, that leads to more favorable partnerships in the future.”

Deciphera recently hired Mike Taylor, a veteran of the bioscience deal-making industry, to serve as its new president and CEO. Taylor communes between Lawrence and Boston offices.

“It’s great to have him on board,” Flynn said. “He brings a good business acumen to the company.”

Deciphera currently has 16 total employees between the Lawrence and Boston offices. Although the company is currently focusing its attention on a few of its drug platforms, Flynn said that Deciphera has no shortage of other drugs with the potential to advance into clinical trials.

“We have a backlog of assets,” Flynn said. “Most companies our size have one or two assets, and they live or die based on those. We have a wealth of riches in our war chest.”

Where Deciphera uses its technology to create new drug formulations to fight cancer, CritiTech specializes in reformulating and improving pharmaceuticals that are already on the market. CritiTech is currently working on a reformulated version of the widely administered chemotherapy drug, Paclitaxel. The reformulated drug, which CritiTech has named Nanotax, performed favorably in a recent Phase I clinical trial focusing on ovarian cancer patients at the KU Medical Center.

CritiTech reformulates existing drugs using proprietary technology that transforms existing drug formulations into very fine particles. The core base of CritiTech’s technology was developed at KU by researcher, Bala Subramaniam, and CritiTech has continued to evolve and expand this technology, according to CritiTech President Matthew McClorey. Reformulating existing drugs into smaller particles can have a number of benefits, including making drugs less toxic, more effective and easier to administer.

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President of CritiTech Matthew McClorey

McClorey said that CritiTech’s reformulation of Paclitaxel into Nanotax is an ideal example of what can be done with CritiTech’s technology. Paclitaxel is currently administered to ovarian cancer patients intravenously using a toxic delivery agent called Cremaphor. By reformulating Paclitaxel into smaller particles using its technology, CritiTech’s reformulated version, Nanotax, can be administered straight into the abdomen using water or saline.

“This is important because the Cremaphor creates significant toxicity for the patients. And because the Paclitaxel is administered into the vein, those toxic effects are systemic,” McClorey said. “The results of Nanotax Phase I trial indicated that it can be delivered at the site of the tumor, in a higher concentration, for a longer period of time, and without the typical side effects and toxicity that is associated with the drug that is currently on the market.”

McClorey said that CritiTech plans to move Nanotax forward in advanced clinical trials, and hopes the drug will be on the market in a few years. He also said that there is a good possibility that Nanotax will be applicable to other cancers including breast, liver and colorectal.

“We think we can improve the lives of ovarian cancer patients with this drug,” McClorey said. “We need to do expanded trials to prove that out, but that is why we are doing what we are doing – to improve the quality of life for these women and hopefully help them to live longer.”

With a solid example of what CritiTech’s technology can do well under way, the company is now starting to offer the technology’s service to other drug companies. Just as CritiTech developed a new and improved version of Paclitaxel, it wants to help other pharmaceutical companies.

“We have started providing this third-party drug development in this past year,” McClorey said. “We have had some contracts coming in from companies that are exploring the use of our technology as applied to the compounds that they are developing. Just like we developed a new and improved version of Paclitaxel, we want to help other pharmaceutical companies develop a new and improved version of their products.”

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