War Paint to Bone Paint: MIT Spinout Aims to Transform Regenerative Meds

Xconomy Boston — 

Driven by 20 years in the military, the founder of Theradaptive hopes his firm’s regenerative “paint” technology platform can transform bone repair, spinal fusion, and sports medicine.

The firm, spun out of MIT, has a computational platform it says turns recombinant proteins into material-binding variants that behave like a paint. This can then be used to coat implants, devices, and injectable carriers to enable long-term local delivery without off-target effects.

“Our approach takes protein sequences that we discover using a lab-based test and optimizes them in several ways using our computational processes,” founder Luis Alvarez (pictured below) told this publication.

“For example, we can take a set of sequences which exhibit tight binding to a given implant material and make those sequences easier to manufacture, bind tighter, and able to survive terminal sterilization. We can also tune the strength of binding so that you can predict the release rate of the protein. This has allowed us to make protein therapeutics that stick to implants like a paint and make them bioactive.”

Alvarez himself served 20 years in the US Army, experience that drove him to develop the technology and target therapies for traumatic orthopedic injuries.

“During my time in Iraq, I witnessed service members who suffered traumatic injuries undergo amputations weeks or months after the initial wound, because there was no reliable method for regenerating the bone,” he said.

“I spent two years as a graduate student at MIT after West Point, but after returning from Iraq I asked the Army to allow me to return to MIT to get my PhD in biological engineering so that I could develop the technology to regenerate tissues.”

As such, Alvarez believes that veterans can bring a unique perspective to problem solving and a warrior ethos that is essential in getting things done. “I see tremendous opportunity for veterans to help push healthcare innovations into the hands of those who need it most,” he said.

Alvarez developed the tech as a Hertz Foundation Fellow at MIT and spun the firm out in 2017. So far, the company has raised over $9 million in non-dilutive funding from the US Department of Defense and the Maryland Stem Cell Research Fund and has also taken investments from strategic partners.

Theradaptive’s tech is being implemented to establish a best-in-class product pipeline in bone repair, spinal fusion, and sports medicine, tapping into a potential market worth $80 billion, according to the firm.

“We have applied our modification to over a dozen proteins with therapeutic applications in these areas and have proven our ability to coat various implant types, including meshes, stents and wafers, with these proteins,” Alvarez said. “For example, in the area of mesh repair we have two proteins that enhance tissue repair locally so that the mesh can be resorbed and eventually replaced by native tissue. In the area of local chemotherapy, we are able to safely bind very high doses of therapeutic proteins and release them locally at a known rate.”

The platform nature of the technology allows Theradaptive to both license the technology out and to develop its own therapeutics.

“We started by licensing our technology to firms with existing 501(k) implants that are compatible with our material-binding therapeutic technology,” said Alvarez. Additional licensing opportunities are being sought to allow the firm to pursue in-house programs in soft tissue repair, and localized therapeutics. The firm’s lead candidate, AMP2 for bone repair and spinal fusion, is looking to enter the clinic in 2021 and as such the firm is considering investment from institutional investors.

“We also have an early-stage program in cell therapy enhancement where we use our implants to potentiate cell therapies that other companies are developing.”

Earlier this year, Theradaptive opened an R&D facility in Frederick, Maryland, expanding capabilities in therapeutic manufacturing, implant design, and additive manufacturing of medical implants. Now plans are underway to establish cGMP manufacturing capabilities to produce therapeutics that will be going into clinical trials in 2021.

When complete, the plant will have the capacity to produce multi-gram quantities of recombinant protein per campaign, using a 200 L stainless-steel bioreactor system and several fermenters along with large capacity chromatography columns, Alvarez said.

Main image: iStock/CIPhotos