We are developing and expanding our pipeline of advanced medicines. Our lead programme is a high value, next generation BMP2 product for spinal fusions, which we plan to have ready for clinical evaluation in 2021.
Locate’s technologies have a wide range of potential clinical applications, both individually and also together as a system.
Our initial product development strategy utilised TAOS for high value regenerative medicine applications in bone repair to provide important validation of the technology, including in cell therapy.
Our lead programme is a high value, next generation BMP2 product for spinal fusions, which will we expect will be ready for clinical evaluation in 2021. We also have a programme delivering mesenchymal stem cells (MSCs) for regenerative medicine applications including bone formation.
TAOS has potential cell therapy applications in a range of tissues throughout the body and we have previously generated compelling in vivo results in areas such as stroke.
IntraStem™ provides additional product opportunities, as it has a broad range of potential applications including gene therapy and ex vivo cell therapy modification and offers major advantages over current approaches.
Locate is currently evaluating a number of new advanced medicine product opportunities both for in-house development and for potential third party collaborations.
For more information on partnering opportunities, please see our Partnering page.
Our current product development pipeline includes the following high value bone repair applications:
Precision delivery of a bone growth-promoting osteoinductive drug (BMP2), where a high control of release is mandated. Designed to offer improved safety and ease of use in both open and minimally invasive surgery compared to current products.
TAOS precisely controls drug release through material degradation rather than simple diffusion. Sustained release profiles can be pre-determined, and the formulation negates the initial ‘burst’ effect typical of other depot release systems, which creates both cost and safety issues. The material then assists in new tissue and blood vessel formation, acting as a substrate upon which the host can rebuild new structural and functional elements.
TAOS BMP-2 brings together established drug delivery methodologies (degradable drug-loaded particles) with a unique tissue scaffolding to create a high-efficacy alternative to current growth factor-releasing products. Formulating the matrix with BMP-2 creates a highly osteoinductive matrix capable of promoting repair in many clinically challenging scenarios. Injectability is a key attribute of the product, with the benign conditions of in vivo scaffold formation maintaining drug efficacy and making enclosed sites accessible.
The lead indication for TAOS-BMP2 is lumbar spinal fusions. Highly encouraging in vivo has been generated to date and formal preclinical development will commence shortly to enable a first in man clinical study in 2021. The market for BMP2 products in lumbar spinal fusion is currently worth ~$750 million per annum.
TAOS®-based mesenchymal stem cells (MSCs) therapy designed to alleviate issues of high cell death and post-transplant migration with non-TAOS stem cell approaches. Successful cell therapy requires not only sufficient numbers of transplanted cells, but also their post-transplantation survival. Employing TAOS as a delivery matrix enables the minimally invasive administration of cells to patients, within a protective and supporting structure.
Locate’s product optimises both the cellular and matrix components to offer a step change in product sophistication and performance. OrthoCell uses expanded allogeneic (i.e. off-the-shelf) MSCs, delivered in an injectable format and at a higher cell dose that possible with the current first wave of products.
Bone generation applications
Locate is evaluating the opportunity to use OrthoCell in a range of regenerative medicine applications, with a lead programme in bone generation.
Certain patient populations have a further drastic need for improved bone formation therapies. For example, diabetes patients suffer from a higher likelihood of protracted or incomplete bone healing. A major contributor here is that the condition affects the proliferative capacity of the patient’s MSCs, which results in bone fusion failure rates as high as 40%. Similar challenges arise in elderly patients and smokers. Bone-forming cell therapies offer an approach that both initiates bone formation through the newly administered cells and amplifies the natural healing process through signalling pathways. A first generation of MSC containing products (collectively termed “cellular bone matrices” or CBMs) have been quick to capture market share. This despite being crudely prepared donor extracts with supply limitations (being harvested from cadavers), variable results and inconclusive clinical outcomes.
OrthoCell has been specifically tailored to adhere high densities of MSCs, which are then able to further expand and freely develop bone–forming properties. The porous structure of TAOS® has also been modified for this use, with the development of porous pellets that maximize the availability of large pores that are required for effective bone cell function. OrthoCell is currently in preclinical development.
TAOS® incorporating an undisclosed antibiotic for the treatment of osteomyelitis. This lead programme is partnered with an undisclosed orthopaedics company and has validated the TAOS platform.
The global bone and joint infections therapeutics market is growing rapidly due the rise in the prevalence and diagnosis of bone and joint infections and the increasing use of antibiotics for the treatment of such infections. Orthopaedic surgical infections currently result in over 1,000 patient deaths annually. The complications with systemic administration of antibiotics, the questionable efficacy of some local administration strategies, the limited selection of antibiotics that are heat stable (for PMMA impregnation), and the costs associated with treatment all drives the need for an alternative method of antibiotic delivery for infected bone.
TAOS® with antibiotic provides an opportunity to precisely control drug release rates (as, unlike other systems, it is degradation controlled), has the added advantage of optimally supporting or promoting the patient’s own bone in-growth, and avoids the complications associated with permanent implants.