Difference between revisions of "Team:Lethbridge/Entrepreneurship"

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<p class="f14">Nomadogen’s foundational technology, a combination genetic and cellular therapy dubbed “Nomadocytes”, is a patented platform that utilizes patient-derived cells to non-invasively deliver therapeutic signals to brain cells specifically affected by stroke, traumatic brain injury and neurodegenerative disease. These signals reprogram neural scar tissue that prevents natural regeneration and rehabilitation into functional neurons, which are predicted to restore lost functionality and facilitate recovery.<br><br>Specifically, Nomadocytes are a genetically modified type of microglia. Microglia, the mobile immune cells of the brain, have three characteristics that make them excellent candidates for delivery of therapies targeting neural injuries and scar tissue: (1) they have been shown to migrate across the blood-brain barrier and travel specifically to sites of neuron death when injected intravenously; (2) they produce nanoparticles called exosomes, which have been previously demonstrated to have significant potential in trafficking brain disease therapies; and (3) microglia can be derived from patient bone marrow cells (Hinze & Stolzing, 2011). The therapeutic process itself involves the introduction of a novel exosomal protein to microglia that enhances both the targeting of therapeutic DNA to exosomes (a process that would also have widespread scientific applications) and the uptake of these exosomes by specific cells in the central nervous system. The therapeutic DNA, a cellular reprogramming gene called <i>NeuroD1</i>, has been previously shown to reprogram specific scar tissue cells into neurons, which are predicted to integrate into existing neural networks, restore lost functionality, and facilitate recovery (Guo <i>et al.,</i> 2014). <br><br>
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<p class="f14">Nomadogen’s foundational technology, a combination genetic and cellular therapy dubbed “Nomadocytes”, is a patented platform that utilizes patient-derived cells to non-invasively deliver therapeutic signals to brain cells specifically affected by stroke, traumatic brain injury and neurodegenerative disease. These signals reprogram neural scar tissue that prevents natural regeneration and rehabilitation into functional neurons, which are predicted to restore lost functionality and facilitate recovery.<br><br>Specifically, Nomadocytes are a genetically modified type of microglia. Microglia, the mobile immune cells of the brain, have three characteristics that make them excellent candidates for delivery of therapies targeting neural injuries and scar tissue: (1) they have been shown to migrate across the blood-brain barrier and travel specifically to sites of neuron death when injected intravenously (Haney <i>et al.,</i> 2012); (2) they produce nanoparticles called exosomes, which have been previously demonstrated to have significant potential in trafficking brain disease therapies; and (3) microglia can be derived from patient bone marrow cells (Hinze & Stolzing, 2011). The therapeutic process itself involves the introduction of a novel exosomal protein to microglia that enhances both the targeting of therapeutic DNA to exosomes (a process that would also have widespread scientific applications) and the uptake of these exosomes by specific cells in the central nervous system. The therapeutic DNA, a cellular reprogramming gene called <i>NeuroD1</i>, has been previously shown to reprogram specific scar tissue cells into neurons, which are predicted to integrate into existing neural networks, restore lost functionality, and facilitate recovery (Guo <i>et al.,</i> 2014). <br><br>
 
Nomadocytes are currently in preclinical trials.</p>
 
Nomadocytes are currently in preclinical trials.</p>
 
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<li class="f10">Guo, Z., Zhang, L., Wu, Z., Chen, Y., Wang, F., & Chen, G. (2014). In vivo direct reprogramming of reactive glial cells into functional neurons after brain injury and in an Alzheimer's disease model. <i>Cell Stem Cell, 14,</i> 188-202.</li>
 
<li class="f10">Guo, Z., Zhang, L., Wu, Z., Chen, Y., Wang, F., & Chen, G. (2014). In vivo direct reprogramming of reactive glial cells into functional neurons after brain injury and in an Alzheimer's disease model. <i>Cell Stem Cell, 14,</i> 188-202.</li>
 
<li class="f10">Hinze, A., & Stolzing, A. (2011). Differentiation of mouse bone marrow derived stem cells toward microglia-like cells. <i>BMC Cell Biol, 12,</i> 35.</li>
 
<li class="f10">Hinze, A., & Stolzing, A. (2011). Differentiation of mouse bone marrow derived stem cells toward microglia-like cells. <i>BMC Cell Biol, 12,</i> 35.</li>
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<li class="f10">Haney, et al. (2013) <i>PLOS ONE, 8,</i> e61852.</li>
 
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Revision as of 02:31, 15 October 2018



Entrepreneur Banner Image

The Lethbridge iGEM team has a history of developing novel targeted delivery methods. In 2014, the Lethbridge team began development of an innovative cell therapy platform designed to non-invasively deliver a therapeutic genetic construct to neural scars to promote functional recovery from stroke, traumatic brain injury, and neurodegenerative disease (for more information, see the 2014 Lethbridge Wiki). Since the 2014 season, two members of the current 2018 Lethbridge team, Aubrey and Zak, have been committed to patenting and commercializing this technology under the start-up, Nomadogen Biotechnologies Inc., which was incorporated in February of 2015.

Nomadogen Company Logo


Company Profile


Nomadogen was initially founded by four graduate student members of the 2014 Lethbridge iGEM team: Zak Stinson, Aubrey Demchuk, Scott Wong, and Evan Caton. Three of the Founders (Zak, Aubrey, and Scott) currently constitute the Board of Directors.



Technology

Nomadogen’s foundational technology, a combination genetic and cellular therapy dubbed “Nomadocytes”, is a patented platform that utilizes patient-derived cells to non-invasively deliver therapeutic signals to brain cells specifically affected by stroke, traumatic brain injury and neurodegenerative disease. These signals reprogram neural scar tissue that prevents natural regeneration and rehabilitation into functional neurons, which are predicted to restore lost functionality and facilitate recovery.

Specifically, Nomadocytes are a genetically modified type of microglia. Microglia, the mobile immune cells of the brain, have three characteristics that make them excellent candidates for delivery of therapies targeting neural injuries and scar tissue: (1) they have been shown to migrate across the blood-brain barrier and travel specifically to sites of neuron death when injected intravenously (Haney et al., 2012); (2) they produce nanoparticles called exosomes, which have been previously demonstrated to have significant potential in trafficking brain disease therapies; and (3) microglia can be derived from patient bone marrow cells (Hinze & Stolzing, 2011). The therapeutic process itself involves the introduction of a novel exosomal protein to microglia that enhances both the targeting of therapeutic DNA to exosomes (a process that would also have widespread scientific applications) and the uptake of these exosomes by specific cells in the central nervous system. The therapeutic DNA, a cellular reprogramming gene called NeuroD1, has been previously shown to reprogram specific scar tissue cells into neurons, which are predicted to integrate into existing neural networks, restore lost functionality, and facilitate recovery (Guo et al., 2014).

Nomadocytes are currently in preclinical trials.



Intellectual Property

The method for generating Nomadocytes is now patented in the USA and patent-pending in Canada:

Wong SA, Stinson ZK, Demchuk AM, Caton EA (2017) Methods and compositions for the packaging of nucleic acids into microglial exosomes for the targeted expression of polypeptides in neural cells.
A) United States Patent and Trademark Office Patent Publication No. 9,840,542. Filed on September 8, 2016; issued on December 12, 2017.
B) Canadian Intellectual Property Office Patent No. CA2903933. Filed on September 11, 2015.



Business Strategy

Strategic Alliances

The University of Lethbridge, unlike many universities, requires no assignment of intellectual property (IP) to the University and so Nomadogen remains the sole owner of these patents. Moreover, the University of Lethbridge offers many resources to encourage student entrepreneurism. For example, to verify that the technology did not infringe on other companies’ patents, a preliminary patentability search was conducted on behalf of Nomadogen by the University-Industry Liaison Office.

The critical factor for future marketing success will be the demonstrated applicability, safety and efficacy of the preclinical Nomadocyte technology through peer review and scientific publication. As such, Nomadogen has developed strong, reciprocal relationships with scientific advisors from the University of Lethbridge for the duration of preclinical development. Since 2014, Dr. Bruce L. McNaughton and Dr. Aaron J. Gruber have continued to generously provide access to specialized laboratory equipment and resources to facilitate ongoing research and development at the Canadian Centre for Behavioural Neuroscience. Thus, Nomadogen has no overhead costs for laboratory and equipment use, liability insurance, or further preclinical development of the technology.

In addition, there is a strong culture of innovation and entrepreneurship both at the University of Lethbridge and in Southern Alberta as a whole. The local small business support network (including organizations such as RINSA, Tecconnect, and Community Futures) have provided numerous funding resources, entrepreneurial guidance, and networking opportunities. Mostly notably, an Alberta Innovates Technology Advisor (Mr. Bill Halley) has been instrumental to our current success.

Business Plan Competitions and Small Business Funding

To fund intellectual property protection within the brief one-year grace period following disclosure of the technology at the 2014 iGEM Jamboree, Nomadogen pursued capital through business plan competitions. First, a business plan was submitted to the small institutional Canadian Centre for Behavioural Neuroscience Business Plan Competition (where we finished in Second Place). Nomadogen then used the feedback from that competition to revise the business plan and went on to win both the Technology and Student streams of the regional 2015 Chinook Entrepreneur Challenge:


The funding received from the Chinook Entrepreneur Challenge was then leveraged towards the Alberta Innovates Micro Voucher program, which together enabled the rapid initiation of intellectual property protection following the iGEM Jamboree.

Phase I-III Clinical Development Plan

Taking a medical biotechnology through human clinical trials is a multimillion dollar endeavour. Once Nomadocytes have been demonstrated as safe and effective through sufficient preclinical testing, Nomadogen has three main options:

1) License the patented technology to established biotechnology companies for all phases of clinical development. This option has little financial risk (as the established company would be responsible for all associated development costs) and Nomadogen would receive a licensing fee for the patent, milestone payments, and future royalties from successfully developed and marketed treatments. This revenue would then be used to pursue development of additional therapies (and patents) and to further grow and establish Nomadogen as a strong competitor in the industry.

2) Proceed through Phase I clinical trials independently with the assistance of an angel investor or as an academic venture. This strategy would require greater financial investment, a longer timeline for investment return, and collaboration with appropriately equipped research facilities and experienced personnel. While this option poses the greatest financial risk to the company and investors, further maturation of the intellectual property as it progresses through clinical trials exponentially increases the technology’s market value.

3) Sell the company (or patent) to a larger biotechnology company that is capable of overseeing both clinical development of the technology and the business. This option would yield the smallest return but is a profitable and viable exit strategy.



Recent Public Engagement

geekStarter Start-Up Workshop

The geekStarter program (managed by MindFuel with funding support from Alberta Innovates) has a long history of supporting iGEM teams in Alberta. On December 2, 2017, Zak was a special guest at the first geekStarter Startup Workshop to offer insights to students and fellow iGEMers on entrepreneurialism, launching a startup, and commercializing biotechnologies.




Campus Alberta Neuroscience

Zak and Aubrey presented their continued progress at the Campus Alberta Neuroscience “Translating Neuroscience from Idea to Impact” symposium on October 18-19, 2018. While one presentation focused on continued research progress, another presentation titled “From iGEM to Entrepreneurship: the challenges of translating student-driven research” outlined their route from idea to commercialization, delineated the current obstacles to student research translation, and highlighted the invaluable opportunities in Alberta for future innovators.




References

  • Guo, Z., Zhang, L., Wu, Z., Chen, Y., Wang, F., & Chen, G. (2014). In vivo direct reprogramming of reactive glial cells into functional neurons after brain injury and in an Alzheimer's disease model. Cell Stem Cell, 14, 188-202.
  • Hinze, A., & Stolzing, A. (2011). Differentiation of mouse bone marrow derived stem cells toward microglia-like cells. BMC Cell Biol, 12, 35.
  • Haney, et al. (2013) PLOS ONE, 8, e61852.