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“I never thought, in my wildest dreams, that I would be able to take something from the laboratory to the bedside. I thought we’d start something and someone else would refine it over a couple of generations of research careers. To have this happen is incredible."

Portrait of Professor David S. Wilkes, whose start-up ImmuneWorks was created with help from IURTC.

David S. Wilkes, Calvin H. English Professor of Medicine and Professor of Microbiology and Immunology

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David S. Wilkes

Calvin H. English Professor of Medicine and Professor of Microbiology and Immunology

For those with advanced lung disease or damage, a lung transplant has been a way to buy a little more time. In fact, patients who receive newly transplanted lungs have just a 50/50 chance of being alive five years later.

Professor David Wilkes, who has devoted his career to improving lung transplant survival rates, may have discovered a way to improve the odds. When donor lungs are introduced in a transplant, Wilkes and his co-investigators learned that a protein called type-V collagen, or collagen V, is released from its normal residence inside connective tissue.

It is the presence of collagen V that incites the body to begin the autoimmune response that can eventually lead to the rejection of a transplanted lung. Professor Wilkes suspected it might be possible to suppress that autoimmune response by conditioning the body with small doses of collagen V before transplantation. Initial animal trials were promising, and the National Institutes of Health encouraged him to write a grant proposal for developing pharmaceutical-grade collagen V.

To create the compound, Professor Wilkes, IU School of Medicine Professor Michael Klemsz, and partners formed a company called ImmuneWorks in 2006, with the help of IURTC.

In 2009, ImmuneWorks received “orphan drug” designation from the United States Food and Drug Administration for its IW001 (bovine Type V Collagen oral solution)—a designation granted for medications that will be used in populations smaller than 200,000 patients.

“The seven years of market exclusivity granted under the orphan drug designation is important for companies such as ours that are developing drugs for small markets because it creates certainty around our market and intellectual property,” says Wade A. Lange, president and chief executive officer of ImmuneWorks.

In 2010, ImmuneWorks entered into a development agreement with Lung Rx, LLC, a subsidiary of United Therapeutics Corporation, to pursue development of IW001 for the treatment of pulmonary fibrosis and primary graft dysfunction in patients receiving lung transplants. Human clinical test is expected to begin in 2010.

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