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Agreements

Date: 2017-01-05

Type of information: Development agreement

Compound: KumaMax

Company: Takeda Pharmaceutical (Japan) PvP Biologics (USA - WN)

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Type agreement: development

Action mechanism:

  • enzyme/synthetic protein. KumaMax is a preclinical, uniquely engineered, recombinant enzyme that is active under acidic stomach conditions and has high specificity for the parts of gluten that cause the autoimmune reaction leading to celiac disease. It targets parts of gluten that cause the autoimmune reaction leading to celiac disease.  This synthetic protein has been created by the UW Institute for Protein Design created. It emerged from a groundbreaking platform credited to a team led by computational biologist David Baker, 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.
  • PvP Biologics exclusively obtained the license in November 2016 to develop KumaMax.
 

Disease: celiac disease

Details:

  • • On January 5, 2017, Takeda Pharmaceutical and PvP Biologics, a University of Washington spin-out, announced a global agreement for the development of KumaMax, a novel enzyme designed to break down the immune-reactive parts of gluten in the stomach, thereby avoiding the painful symptoms and damage done in the small intestine from accidental gluten ingestion. Under the terms of the development agreement, PvP will conduct all research and development through phase 1 proof-of-principle studies per a pre-defined development plan. It is estimated that celiac disease affects 1 in 100 people worldwide. Celiac disease causes significant health problems, including acute gastrointestinal symptoms, malnutrition, weakness, and failure to thrive. Celiac disease can develop at any age and, if left untreated, can lead to additional serious health problems.1 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. Towards this end, we are advancing a product candidate designed to break down the immuno-reactive 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 University of Washington and exclusively in-licensed by PvP Biologics. PvP Biologics has corporate offices in San Diego and research laboratories in Seattle.

Financial terms:

  • Takeda will fund $35 million for PvP’s expenses related to the plan in exchange for an exclusive option to acquire PvP following receipt of a pre-defined data package. Upon PvP’s successful completion of the development plan, Takeda may exercise its option to acquire PvP by paying an undisclosed fee as well as development and regulatory milestones.

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