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.
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.
Asit Parikh, head of the gastroenterology therapeutic area for Takeda, said: “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.
“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.”
Adam Simpson, president and CEO of PvP Biologics, said: “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.
“In addition, the significant non-dilutive financing provided by Takeda will accelerate therapeutic development of KumaMax.”
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.
Currently, the only treatment available for celiac disease patients is a strict gluten-free diet, which is challenging to maintain. For celiac patients attempting to maintain a gluten-free diet but who may accidentally ingest gluten, KumaMax has the potential to degrade the immune-reactive parts of gluten before they exit the stomach in order to decrease an immune response and reduce the symptoms and intestinal damage associated with celiac disease.
Tadataka “Tachi” Yamada, MD, chairman of PvP Biologics, said: “Celiac disease is a disorder in which the ingestion of even a trace amount of gluten can damage the small intestine.
“In pre-clinical experiments, KumaMax has shown the ability to degrade gluten with sufficient efficiency and effectiveness to indicate its exciting potential as an oral therapy for a disease that impairs the lives of millions.”
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.