- Takeda has exercised its option to buy U.S.-based PvP Biologics after seeing Phase 1 data from its only candidate, a celiac disease drug called KumaMax that was invented by a University of Washington undergraduate team.
- The deal will be worth up to $330 million for PvP's owners, based on development and regulatory milestones for KumaMax, which will now be called TAK-062. Takeda signed PvP to an option deal in 2017, which provided $35 million to cover research costs and allowed the company to bypass traditional venture capital funding.
- In Takeda's pipeline, TAK-062 will join TAK-101 in clinical trials for celiac disease. The latter was in-licensed from COUR Pharmaceutical last year.
TAK-062 was designed as a highly potent super glutenase, which can help break down gluten in the digestive system. A synthetic biology team from the University of Washington designed it as part of a contest, using an enzyme secreted by the bacteria Alicyclobacillus sendaiensis, and then modified it to have greater activity and specificity.
Celiac disease patients have an immune response when they consume gluten, which damages their digestive systems.
PvP has tested TAK-062 in a Phase 1 trial in both healthy patients and those with celiac disease. In the healthy patients, the trial measured the drug's ability to degrade gluten, in addition to safety and tolerability.
The two companies did not disclose results from the Phase 1 trial but will present them at an upcoming medical meeting. Its advancement will be rapid, as Takeda has already planned a Phase 2b trial in patients with uncontrolled celiac disease on a gluten-free diet.
Takeda lists both TAK-062 and TAK-101 as part of its "wave 2" of experimental drug candidates, which it expects to launch in 2025 or after.
Rather than breaking down gluten, TAK-101 seeks to modulate immune response, and data from a Phase 2a study showed patients were better able to tolerate a gluten challenge after treatment with TAK-101.
In signing deals with Takeda, both COUR and PvP have joined forces with one of the sector's leaders in gastrointestinal disease.
The Japanese pharma group markets Entyvio for Crohn's disease and ulcerative colitis, Gattex for short bowel syndrome and Amitiza for irritable bowel syndrome with constipation. About 21% of its sales are in gastrointestinal disease