OsteoAdapt: a cut above

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OsteoAdapt

A new engineered protein technology being developed by an Iraq War veteran could potentially save thousands of Australian animals from undergoing life-changing limb amputations. By Tracey Porter

Dr Luis Alvarez knows all too well the debilitating effects of bone cancer, infection, tissue necrosis and limb paralysis.

Indeed, after witnessing countless comrades having to undergo delayed amputation of limbs due to the horrific injuries caused by contact with improvised explosive devices, the US military veteran felt compelled to investigate alternatives.

Now he is applying what he has learned from his years studying biological engineering to a unique regenerative medicine program that could not only prevent unnecessary limb amputation in animals but could also help veterinarians treating patients with persistent fractures, torn cranial cruciate ligaments, tooth decay, jaw injuries, cranio-facial injuries, and joint degeneration.

How it works

Through his venture-backed biopharmaceutical company, Theradaptive, Dr Alvarez and his team have utilised a proprietary engineering process to create material-binding variants of proteins such as bone morphogenetic protein 2 (BMP2), a naturally occurring protein that promotes bone growth. 

The company’s own engineered molecule, AMP2, maintains the activity of BMP2 but also is able to bind to surgical implants extremely tightly, keeping it localised to the implant site.

Dr Alvarez says it is this key differentiator which makes the protein safer to deliver.

“[We have] combined AMP2 with an implant material that remodels into bone, creating a product called OsteoAdapt, [which is] molded and placed where bone needs to regenerate. Having AMP2 securely bound in the form of OsteoAdapt keeps the therapeutic treatment precisely and persistently where it is most needed and does not migrate away,” he says.

[We have] combined AMP2 with an implant material that remodels into bone, creating a product called OsteoAdapt, [which is] molded and placed where bone needs to regenerate. Having AMP2 securely bound in the form of OsteoAdapt keeps the therapeutic treatment precisely and persistently where it is most needed and does not migrate away.

Dr Luis Alvarez, founder, Theradaptive

“When you have control over the localisation and bioactivity of an engineered protein, not only are biologics then more precisely targeted, but it also becomes possible to tune their therapeutic effect with much greater precision.”

Why amputate?

Dr Alvarez says typically limb amputation is an extreme last resort, which most veterinarians and pet owners want to avoid at any cost. 

There are a variety of reasons why amputation may be presented as a treatment option including cases where there is a diagnosis of osteosarcoma (bone cancer), an infection that has caused tissue necrosis or threatens to spread throughout the body, limb paralysis, chronic pain, or severe arthritis or osteoporosis, that may mean a vet has no choice but to amputate the impacted limb. 

It may also be considered the best option if the animal has a limb deformity which affects its quality of life or if the animal has sustained blunt force trauma, such as a crush injury from having been hit by a vehicle, which has caused major damage and fractures. 

Although many animals undergo amputations and continue to lead full lives, Dr Alvarez says such operations can cause complications and negatively affect an animal’s quality of life. Not only can limb amputation cause mobility and balance issues, but it can also put abnormal strain on the other three legs, leading to arthritis of the remaining limb bones so that animals are back at square one.

In some cases, particularly in horses, it is simply not possible to undergo limb amputation, he says. “Horses must distribute their weight evenly on all four legs. Although prosthetics are available, they are rare and often expensive. [Our] platform therefore provides veterinarians with an alternative to the usually inevitable route of euthanasia.”  

Alternatives

Dr Alvarez says previous bone repair and spinal fusion techniques have relied on BMP2 to induce bone infusion. 

However, such products raise safety concerns due to their lack of precision and retention, causing complications and negative side effects such as unpredictable and off-target bone growth and inflammation. 

We have a plethora of data that show it is safe and effective in animals and has consistently outperformed the current best-in- class treatment, [and] are excited to be working with some of the top veterinarians in the field to get this product in the hands of veterinarians everywhere.

Dr Luis Alvarez, founder, Theradaptive

The sole bone growth factor that is currently available for use in veterinary practice is only available through humanitarian exceptions and is extremely expensive. 

Dr Alvarez says pre-clinical studies to date have shown that OsteoAdapt outperforms the current standard of care for bone regeneration. 

Having it available to veterinarians will save practitioners time and their clients money because there will be less of a need for aftercare or extended follow-up appointments, he adds.

Industry acceptance

Dr Alvarez says evidence suggests key opinion leaders from the veterinary field see such advancements as a big positive for the industry, primarily because many different species stand to potentially benefit.

Dr Alvarez says he has vet practitioners out in the field ready to use this product “as early as this week. They range from veterinarians who treat small animals such as cats and dogs, as well as large animals such as horses. We have also reached out to an elephant rescue organisation in Thailand to help treat elephants who have been injured by landmines. 

“We have a plethora of data that show it is safe and effective in animals and has consistently outperformed the current best-in- class treatment, [and] are excited to be working with some of the top veterinarians in the field to get this product in the hands of veterinarians everywhere.”

Having sailed through animal trials, Dr Alvarez’s company closed a US$26 million Series A funding round in 2023 which helped advance development of its targeted regenerative therapeutics. 

In addition, it received a US$4 million grant from the U.S. Department of Defense which will enable Theradaptive to continue its work to meet regulatory requirements and scale up its manufacturing in preparation for clinical studies.

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