UW Spin-Out Seeks to Develop Celiac Disease Therapy

December 20, 2016

SEATTLE and SAN DIEGO, Dec. 20, 2016 – PvP Biologics, a University of Washington spin-out, is advancing a scientifically designed enzyme that could help people with celiac disease.

The UW Institute for Protein Design created the enzyme, called KumaMax. It targets parts of gluten that cause the autoimmune reaction leading to celiac disease. The disease affects an estimated 2.4 million Americans.

PvP Biologics exclusively obtained the license in November 2016 to develop KumaMax. This is the Institute of Protein Design’s first promising synthetic protein to be slated for development for potential clinical usage.

The enzyme emerged from a groundbreaking platform credited to a team led by computational biologist David Baker, UW professor of biochemistry and Institute for Protein Design director. The software, called Rosetta, makes it possible to create made-to-order proteins unlike any found in nature. These include novel enzymes, like KumaMax, potent antivirals, nanocage drug delivery vehicles, and complex, self-assembling protein nanostructures.

“By using the powerful computational software developed at the Institute,” said UW Medicine translational investigator Ingrid Swanson Pultz, co-founder of PvP Biologics, “we constructed an enzyme to survive and function in the harsh acidic environment of the stomach and to specifically degrade gliadin, the immunoreactive part of gluten.”

Gluten is a protein present in wheat and other cereal grains. In people with celiac disease, the gluten component, gliadin, triggers an immune reaction. The lining of the small intestine becomes inflamed.  Consequently, nutrient absorption is impaired.  A treatment approach to break down gliadin in the stomach might prevent the autoimmune reaction.

Celiac disease causes significant health problems, including acute gastrointestinal symptoms, malnutrition, weakness and failure to thrive. In severe cases, celiac disease can spur intestinal cancer and lymphoma, a cancer of the immune system.

For some people with celiac disease, even a trace amount of gluten can be a serious health hazard.  UW Medicine researchers were encouraged because early preclinical studies have shown KumaMax is highly effective at breaking down gliadin in acidic stomach conditions.  This raised hope that it could be administered in a form that can be swallowed.

Celiac disease is currently treated by a gluten-free diet, which is costly and difficult to maintain. Many patients continue to report persistent symptoms despite adhering to a gluten-free diet.

“At PvP Biologics, we plan to rapidly advance KumaMax into clinical trials with the ultimate goal of helping people who have celiac disease avoid the painful symptoms and damage done in the small intestine from accidental gluten ingestion,” said Adam Simpson, president and chief executive officer of PvP Biologics.

An early version of the enzyme was designed and constructed as part of the International Genetically Engineered Machine (iGEM) Competition and Howard Hughes Medical Institute support for the Baker lab. The Life Sciences Discovery Fund supported further development of the enzyme, and awarded a competitive $250,000 matching grant in 2015 to conduct animal efficacy studies and safety testing for the enzyme, as well as to develop a cost-efficient and scalable production method.  The amount was matched by philanthropic donor funding.

The Institute for Protein Design benefits from a UW program for investigators to take discovery through to commercialization.

PvP Biologics was launched through CoMotion at the UW, the collaborative innovation hub dedicated to expanding the societal impact of the UW community. By developing and connecting local and global innovation ecosystems, CoMotion helps innovators achieve the greatest impact from their discovery.

PvP Biologics will be completing preclinical studies to advance KumaMax into clinical trials necessary for U.S. Food and Drug Administration (FDA) approval.

About UW Medicine 

UW Medicine is one of the top-rated academic medical systems in the world. With a mission to improve the health of the public, UW Medicine educates the next generation of physicians and scientists, leads one of the world’s largest and most comprehensive medical research programs, and provides outstanding care to patients from across the globe. The School of Medicine faculty is second in the nation in federal research grants and contracts with $727.5 million in total revenue (fiscal year 2015) according to the Association of American Medical Colleges.  For more information, go to

About PvP Biologics

PvP Biologics is developing an oral enzyme for the treatment of celiac disease. Our mission is to develop a highly effective therapeutic product to reduce the burden of living with this disease. Toward this end, we are advancing a product candidate designed to break down the immunoreactive parts of gluten in the stomach and thereby avoid the painful symptoms and damage done in the small intestine from accidental gluten ingestion. The technology was invented at the Institute for Protein Design at the University of Washington and exclusively in-licensed by PvP Biologics. PvP Biologics has corporate offices in San Diego and research laboratories in Seattle.

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