Christiana Care Gene Editing Institute prepares new lung cancer drug application based on its research

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Christiana Care Health System’s Gene Editing Institute is preparing its preliminary investigational new drug application (IND) with the U.S. Food and Drug Administration. This marks the first time Christiana Care’s Gene Editing Institute is developing its own investigator-initiated clinical trial for FDA approval.

The  Gene Editing Institute will use the CRISPR genome editing platform to improve the effectiveness of chemotherapy for treating K-ras-positive non-small-cell lung cancer.

 Patients with the  disease have such a strong resistance to chemotherapy that even patients not yet treated for their cancer are resistant to it. Other patients become resistant to chemotherapy after treatment..

 “While we all hope for cures, the pioneering work of our gene editing team is making it a priority to improve the lives of today’s patients who are suffering with cancer and other diseases,” said Janice E. Nevin, M.D,   CEO of Christiana Care Health System

 “This exciting study represents a trio of firsts,” said Nicholas J. Petrelli, M.D., Bank of America endowed medical director of the Helen F. Graham Cancer Center & Research Institute at Christiana Care. “It will be the first lung cancer clinical trial carried out by a gene editing program embedded in a community cancer center. While our Gene Editing Institute has a great deal of translational research experience, this will be its first study to move scientific discovery toward an IND application. And, it will also be the first time that we will be investigating technology that was grown organically at the Gene Editing Institute.”

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“We are confident that the results of our animal studies now enable us to take the next step in the FDA approval process for a cancer clinical trial using CRISPR,” said Eric Kmiec, Ph.D., director of Christiana Care’s Gene Editing Institute. “It is an exciting journey. Our effort positions the Gene Editing Institute as a leader in bringing this heralded technology to people who need it most. Lots of translational scientists are providing advice on this genetic target. Once we get to a clinical trial, our results could have a major impact on our patients, and patients around the country and world.” 

The Gene Editing Institute will work closely with  regarded Certara’s regulatory science division, Synchrogenix, in its IND application with the FDA. 

“Certara brings expertise for this process and we are delighted to have them on board,” said   Kmiec. The company has authored more than 20 investigational new drug applications the past two years.

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