Takeda and PvP Biologics have formed an 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.

PvP will conduct all research and development through phase 1 proof-of-principle studies per a pre-defined development plan. 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.

“This agreement with PvP Biologics reinforces Takeda’s commitment to developing therapeutics targeting celiac disease. KumaMax could address a significant unmet need for celiac patients who try, but are unable to completely avoid gluten exposure in their diets, and thus continue to experience debilitating symptoms,” said Asit Parikh, head of the gastroenterology therapeutic area, Takeda. “We are pleased to be partnering with PvP Biologics, a company whose management team has a proven track record of successfully bringing assets that target chronic inflammatory GI diseases through development.”

“Takeda’s GI experience and capabilities are a great fit with our goal of developing a novel oral enzyme therapy to make a meaningful impact on the lives of people with celiac disease,” said Adam Simpson, president and chief executive officer, PvP Biologics. “In addition, the significant non-dilutive financing provided by Takeda will accelerate therapeutic development of KumaMax.”