Takeda Acquires PvP Biologics
Takeda, the Japanese pharma company has exercised its option to acquire the San Diego-based PvP Biologics company for $330 million three years after both the companies inked a $35 million deal to develop a novel treatment for celiac disease.
After the Phase I trial conclusion for TAK-062, also known as Kuma062 (developed for uncontrolled celiac disease), Takeda and PvP will enter into the agreement. A uniquely engineered recombinant enzyme having high specificity for the parts of gluten that cause the autoimmune reaction leading to celiac disease and is active under acidic stomach conditions, Kuma062 was tested by PvP in its first-in-human clinical studies for Kuma062. Takeda said in its announcement that to treat celiac disease, TAK-062 is the computationally engineered potential best-in-class treatment.
A genetically driven chronic immune-mediated disorder, celiac disease is an inflammation and damage of the small intestine caused by abnormal immune responses to gluten peptides. Takeda said, maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins is the only available treatment for patients with the celiac disease currently.
Takeda’s commitment to developing treatments for gastrointestinal disorders will be enhanced by the acquisition of PvP. In the company’s arsenal
, TAK-062 is the second celiac-focused product. From COUR Pharmaceuticals, Takeda acquired the license for a first-in-class celiac treatment in October. TAK-101 contains gliadin protein and is an immune modifying nanoparticle. Following positive Phase IIa proof-of-concept, the company struck the deal with COUR. T-cell response suppression was demonstrated by TAK-101 in the study. This suggests that by immune uptake of proprietary nanoparticles loaded with gliadin proteins, a disease-specific antigen in patients with celiac disease, it may induce tolerance to gluten.In celiac patients who maintained a gluten-free diet, Takeda plans to initiate a Phase IIb efficacy and dose-ranging trial for TAK-062 when the acquisition of PvP is complete. For a presentation at an upcoming medical congress, the company also plans to submit data from the Phase I safety and tolerability study.
In order to avoid inflammatory flare-ups from the disorder, the head of Takeda’s Gastroenterology Therapeutic Area Unit, Asit Parikh noted the difficultly of celiac patients in maintaining that strict diet. For these patients, TAK-062 has the potential to become a game-changer, said Asit Parikh.
In celiac disease, the standard of care can be changed by TAK-062 as it is demonstrated in PvP Biologics’ work as a highly targeted therapy. Parikh said in a statement, “to advance the clinical study of TAK-062 and TAK-101, we are now applying our deep expertise in gastrointestinal diseases, two programs with different modalities that have both demonstrated clinical proof of mechanism.”
The chief executive officer, president of PvP Biologics, Adam Simpson said that in development for the treatment of celiac disease, in order to overcome the challenges seen by previous glutenases, especially their lack of activity in the acidic conditions of the stomach and specificity for gluten, TAK-062 was developed. In humans, TAK-062 demonstrated robust gluten degradation over the course of its development.
The working of TAK-062 involves digesting gluten enzymatically. In order to prevent the immune response to gluten and eliminate the symptoms and intestinal damage caused by celiac disease, TAK-062 is designed to degrade the immune-reactive parts of gluten before they exit the stomach. Takeda said, compared to other glutenases, the medication has demonstrated enhanced catalytic activity.
Takeda Acquires PvP Biologics – Source
