Boston-based biotechnology company Theradaptive, Inc. and Japanese orthopedic biologic company ORTHOREBIRTH Co. Ltd. have announced an exclusive license agreement to develop and market a product called THX-14.
Groundbreaking BMP-2 Based Trauma Product in the Works
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The product is composed of Theradaptive’s proprietary material-binding biologic, Bone Morphogenetic Protein 2 (tBMP-2) and ORTHOREBIRTH’s 510K-approved void-filling material ReBOSSIS. If approved, THX-14 will be a groundbreaking product, the first regenerative therapeutic for traumatic bone injuries and congenital skeletal defects.
Under the terms of the agreement, ORTHOREBIRTH will be responsible for THX-14 development and commercialization in Asia and Theradaptive will be in charge of American development and marketing, with joint responsibility for international clinical studies and coordinating launch events. Theradaptive will receive milestone payments and additional royalties on any ongoing product sales in licensed territory.
In a recently completed preclinical study by Theradaptive, THX-14 was observed to strongly induce bone regeneration and demonstrated superiority over autologous bone marrow. No serious adverse events were observed. Theradaptive aims to continue clinical research, with a phase I/II human study planned for 2020.
Around 16,000 people die every day from traumatic injuries and musculoskeletal injuries account for 16% of the global burden of disease, according to the World Health Organization.
Luis M. Alvarez, Ph.D., Theradaptive’s founder and CEO, told OTW, “We are thrilled to partner with ORTHOREBIRTH for the development of THX-14. This partnership places the power of a global development network behind a therapeutic delivery product that is poised to revolutionize the orthopedic repair market.”
Alvarez continued, “For many years, promising therapeutics have been hindered by the challenges of delivering those therapeutics precisely. For orthopedic applications, THX-14 aims to solve this problem by combining our material-binding bone growth factor (tBMP-2) with ORTHOREBIRTH’s void filling material. THX-14 has the potential to become the first regenerative treatment for congenital skeletal defects, as well as the most effective repair solution for traumatic orthopedic injuries.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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