[Corrected 1/5/17, 8:07 am to show company was spun out of UW two months ago.] A San Diego-based startup spun out from the University of Washington just two months ago is today announcing a $35 million deal with Takeda, Japan’s biggest pharmaceutical.
PvP Biologics was founded to advance KumaMax, a synthetic enzyme (depicted in the above image) that shows promise as an oral drug for treating celiac disease. Almost from the beginning, the idea was to forego traditional venture financing and go straight to a pharma deal, PvP CEO Adam Simpson said by phone yesterday.
“It’s a very innovative transaction,” Simpson said.
Takeda agreed to provide all $35 million in exchange for an exclusive option to acquire PvP once the biotech has completed a pre-determined drug development plan and delivered a pre-defined data package for KumaMax. Takeda’s funding is intended to take the biologic drug through phase 1 proof-of-principle studies, Simpson said.
In a joint statement, Takeda and PvP Biologics describe KumaMax as an engineered, recombinant enzyme that remains active in the highly acidic conditions of the stomach. It has a “high specificity” for gliadin, a gluten fragment that triggers an immune response for some people that can lead to celiac disease.
“People with celiac disease mount an immune response to these incompletely digested gluten fragments as they pass into the intestines,” said Ingrid Swanson Pultz, a leader in computational enzyme design at the University of Washington’s Institute for Protein Design, which originally developed KumaMax. The enzyme has the potential to degrade the immune-reactive fragments of gluten before they move into the intestines, where the immune response wreaks havoc, PvP said.
(Pultz provided the computer-generated image of the KumaMax enzyme, created by Vikram Mulligan at the University of Washingon, depicting how KumaMax envelops a gluten protein fragment, shown as a yellow-green structure.)
“There’s currently nothing on the market for celiac disease, nothing that’s FDA-approved,” Simpson said. “We think it’s a tremendous unmet need.”
According to PvP Biologics, the only current treatment for celiac disease is a strict gluten-free diet, which can be challenging to maintain. The company estimates