27 April 2020 - - US-based healthcare company ProThera Biologics, Inc. and Japan-based Takeda Pharmaceutical company Ltd. (TSX: 4502) (NYSE: TAK) have entered into a global licensing agreement to develop a novel plasma-derived Inter-alpha Inhibitor Proteins therapy for the treatment of acute inflammatory conditions, the company said.

Early research has indicated that this IAIP technology has the potential to deliver a highly innovative, disease-modifying treatment for a range of acute inflammatory diseases.

In such conditions, dysregulated inflammation plays a key role in the pathology, and there are no effective treatments available TODAY.

IAIP are naturally occurring proteins that circulate in the blood, and extensive research at ProThera has shown that these proteins play an essential role in human health by controlling inflammation.

They exert their anti-inflammatory effects through multiple mechanisms and have the potential to change the paradigm of treatment for patients with dysregulated immune responses.

During acute illnesses, however, the levels of these anti-inflammatory proteins rapidly decline.

A replenishment strategy for patients using Inter-alpha Inhibitors is supported by numerous preclinical studies.

As part of the agreement, ProThera and Takeda will work together on IND-enabling activities, with development led by Takeda's dedicated Plasma Derived Therapies R and D organisation.

The broad collaboration will also explore the development of companion diagnostics with the goal of personalising patient treatment and maximizing real-world outcomes.

Takeda will assume responsibility for funding all development and commercialization activities.

The financial terms of the licensing agreement are not being disclosed.

ProThera Biologics has focused since inception on developing Inter-alpha Inhibitor Proteins for the treatment of life-threatening inflammatory diseases along with a rapid, point of care diagnostic test to determine IAIP levels for use as a biomarker for patient progression to severe outcomes.

ProThera has demonstrated the potential of IAIP therapy in numerous preclinical models and the use of IAIP as a biomarker in clinical samples.

The company was co-founded by Yow-Pin Lim, M.D., Ph.D., and Douglas Hixson, Ph.D., faculty members at the Warren Alpert Medical School of Brown University, based upon research originating in the labs at Lifespan/Rhode Island Hospital, with seed funding from the R.I.-based Slater Technology Fund. 

In developing its technology, ProThera has collaborated with investigators at multiple academic research institutions and has been awarded in excess of USD 12m in federal funding from agencies within the National Institutes of Health pursuant to Small Business Investment Research grants.

The company has received continued investment from the Slater Fund, and has also received support from R.I. Commerce Corp. through its Innovate RI Small Business Fund.

Approximately USD 4m in Phase II SBIR grants from the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Allergy and Infectious Disease (NIAID) is currently supporting collaborative research with Care New England/Women and Infants Hospital on neonatal brain injury as well as the rapid test to assist therapy in infants with life-threatening diseases.

Takeda Pharmaceutical company Ltd. (TSX: 4502) (NYSE: TAK) is a global biopharmaceutical firm headquartered in Japan.

Takeda focuses its R and D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology.