TMI Commercialization

Product Development Initiative and Commercialization

C. Wayne McIlwraith, DVM, PhD

The vision that was proposed for what we were then calling an Institute of Biologic Translational Therapies to John and Leslie Malone in December 2015 was to bring outstanding researchers and resources together in a state-of-the-art facility to create the first world renowned institute that leverages basic science in biologic therapy  in to clinical use. Our mission was to provide a mechanism for basic science research in the area of biologic therapies to be further assessed and validated using clinically relevant models and optimized for clinical use.

This initial plan resonated with the Malones, after we had received the initial support from John and Leslie, meetings of the Faculty Steering Committee retained this central theme but there was an evolution where our vison was “Leading the way in discovery and implementation of the body’s therapeutics to improve the lives of animals and their humans” and a mission to “To improve the lives of animals and humans through biologic therapies created via the collaborative work of leading scientists and clinicians; to expedite the availability of these therapies, and to promote education related to these goals”. Major focus at this time was that we wanted to “fast track” these therapies to patients.

Once we were in the TMI, Interim Director, Brett Anderson, formed a Product Development Initiatives Group and this led to principal investigators providing summaries of appropriate projects to each other. This has resulted in a list of entrepreneurial prospects at the TMI. Working with investigators these projects are the first step to expand funding opportunities, data resources, and research infrastructure that will attract new industry partners and deliver on the commitment to make an impact on the lives of humans and animals.

Projects in the pipeline:

  • Use of metabolomics-based platform for early diagnosis, clarification of pathogenesis, response to therapies of joint disease and prediction of catastrophic musculoskeletal injury. 

    • Clinical disease is often well established before it is recognized and delayed intervention is often believed to limit treatment success.

    • Sensitive and specific objective therapeutic monitoring is costly, time-consuming and cumbersome for worldwide application.

    • Our solutions include partnering with scientists at a company, Arion Analytics, LLC, where we have done 3 proof of concept studies with MMR and MS profiling demonstrating the ability to differentiate groups based on their metabolomics profiles. We are working on establishing a discovery database for bone and joint-related biomarkers with the ultimate development of a simple field test kit (but protected by IP). The team consists of Drs. Frisbie and McIlwraith at TMI working with Drs. Hamid Eghbalnia and Mr. Paul Rosevear.

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  • The development of a standing equine Computed Tomography Unit (CT) using cone beam technology. There are a number of studies done (some by us and some elsewhere) showing the value of CT to show early bone change in the equine athlete. However, the use of CT is handicapped by the need to anesthetize the horse to get good images.

    • This project is led by Drs. Kawcak and McIlwraith at TMI working with EPICA to develop a prototype standing CT that can be used safely in horses. The prototype is getting close to delivery from Italy to the TMI and then we will go further with algorithm and software development.

    • Unique features include, the instrument will be 1/3 of the cost of existing units, established service and care will be supported, the machine is portable, earlier algorithm development has been made and other customization developments are being done.

    • The plan is to complete the algorithm development of the prototype at CSU and then beta units will be made and sent to 3 partners (tentatively Rood and Riddle Equine Hospital, Santa Anita Race Track and Fair Hill Training Center).

    • The ability to do standing CT conveniently and inexpensively could greatly enhance the ability to predict severe injury in the equine athlete which is a major equine welfare issue.

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  • Broadly active topical immunotherapy for preventing respiratory infections and treating ocular infections and cancer. MucosImmune (respiratory) & Ocummune (ophthalmic) technology using a combination of cationic liposomes as a delivery system, anti-viral/antibacterial immune response triggers (TLR3/9 agonists) and a cell adhesive (potency; sustained immunity activation). 

    • This project is being led by Drs. Steve Dow and Mike Lappin at the TMI in partnership with Laporte Immunotherapeutics, Steve Tyrrell, CEO, Dr. Kathryn Wotman an Assistant Professor and Ophthalmologist in the department of Clinical Sciences at CSU and Dr. Lyndah Chow a Research Scientist at TMI who leads studies to elucidate mechanisms of action of core immune-activating technology.

    • MucosImmune (respiratory) & Ocummune (ophthalmic) technology using a combination of cationic liposomes as a delivery system, anti-viral/antibacterial immune response triggers (TLR3/9 agonists) and a cell adhesive (potency; sustained immunity activation). 

    • Proof of concept has been gained in multiple animal models including protection from pneumonia and multiple different bacterial and viral infection models, regression of ocular herpes virus infection in squamous cell carcinoma in cat and horse models and suppression of CoV-2 replication in vitro. 

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  • ART-BIO is a freeze-dried allogeneic equivalent to IRAP™ and IRAP II™. Currently we have had much success with autologous conditioned serum (available as 2 products IRAP I and IRAP II). This process involves taking blood from a patient, incubating it for 24 hours with a special container taking glass beads followed by centrifugation and with several vials of intraarticular product. 

    • This work is being led by Dr. Dave Frisbie in the Orthopedic Research Center and the team consists of Drs. Frisbie and Wayne McIlwraith at TMI, Jeff Christianson Director of Operations at ART, Dr Margo McPherson (reproduction KOL and key advisor) and Tony Gawaldo of Arthrex (sales and marketing).

    • The project has shown that autologous conditioned serum can be taken from an allogeneic donor, freeze-dried and in vitro shows an equivalency in the production of the beneficial cytokines that is the mechanism of action of this product.

    • The development of a freeze-dried “off the shelf”, product means that the veterinarian can have a point of care product with no processing, it will have already been quality tested, it is stable at room temperature for ease of storage, we can prepare from “super producing” donors (it has been shown that some donors are a lot better than others and it is easy to use.

    • At this stage, it is planned to manufacture products in partnership with Advanced Regenerative Therapies (ART™) and we will partner with Arthrex Inc. for marketing and sales.
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