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SBIR-STTR

  • sam patrick posted an article
    Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more

    South Carolina’s Integrated Micro-Chromatography Systems, Inc. (IMCS), a leader in recombinant enzymes and micro-chromatography technologies, was awarded $1.8 million for Phase II of its Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health/ National Institute of General Medical Sciences (NIH/NIGMS).

    Combined with earlier SBIR funding, the grant will provide scientists access to affordable gangliosides that aid in developing therapeutics and diagnostics for neurological diseases including Huntington's Disease, Parkinson's Disease, and Alzheimer's Disease.

    The NIH/NIGMS previously awarded IMCS a 4-year, $2.56 million Fast-Track Small Business Technology Transfer (STTR) grant to expand the glycan toolkit and build an extensive array of sialoglycans that advance glycobiology-related research. The combined Fast-Track grants for the projects now exceeds $5.25 million. These projects will provide the scientific community access to affordable, easy-to-use reaction kits to facilitate synthesis of various glycans to advance research into potential diagnostics and therapeutics for neurodegenerative diseases.

    The SBIR project is headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS, along with Xi Chen, Ph.D., Professor of Chemistry at the University of California, Davis. The STTR project is in collaboration with Hai Yu, Ph.D., Project Scientist at the UC-Davis.

    Glycobiology, the study of the biological impact of sugars, has gained momentum in recent years. The surfaces of viruses, bacteria, and cells of our bodies are decorated with unique sugars or glycans. Some viruses and bacteria can exploit glycans to wreak havoc on our bodies, while a lack of glycans can result in disease progression. Studies suggest that modifications to certain glycans in molecules related to the brain are implicated in the onset and progression of neurodegenerative diseases.

    To date, the high cost of reagents and materials needed for glycobiology research have contributed to few tools to study glycans. Glycan-modified cell membranes (glycolipids) and gangliosides (a component of brain matter critical to research) must be harvested from pigs, sheep, and cows as there is currently no cost-effective manufacturing process. The biosynthetic manufacturing technology used for these projects will result in animal-free gangliosides.

    Matthew Macauley, Ph.D., Assistant Professor of Chemistry at the University of Alberta, is eager to access significant quantities of gangliosides. "Some experiments with glycolipids are cost-prohibitive, but scalable and facile access to glycolipids would make such experiments financially feasible,” he noted.

    While not involved in the grant, Dr. Macauley’s lab studies glycan-binding proteins called Siglecs and their impact on disease states such as Alzheimer’s. Noting that commercially available glycolipids do not capture the diversity needed in research, he notes that reaction kits funded by the grant could be “a tremendous help for a lab that doesn't have expertise with glycan synthesis and doesn’t want to invest in getting all these enzymes expressed.”

    Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Numbers R44GM139441 and R42GM143998. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

    About IMCS

    Integrated Micro-Chromatography Systems, Inc is a privately held biotechnology company that strives to address the growing needs of clinical and research laboratories through innovative technologies and custom solutions designed to increase testing efficiency. IMCS creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology, academic research facilities, US Government agencies, and health science companies around the world.

  • sam patrick posted an article
    Funds to be used for scale-up, implementation of cGMP quality system see more

    Zylö Therapeutics Inc., developer of the transformational Z-pod™ topical delivery platform, has been awarded a $1,700,000 Small Business Innovation Research (SBIR) grant to advance Zylö’s proprietary nitric-oxide-releasing topical drug candidate into clinical trials. The grant, titled “Development of microparticle-based topical treatments for treating erectile dysfunction [‘ED’] in patients refractory to oral PDE5 inhibitors,” was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (a division of the NIH).

    The principal investigator of the project is Andrew Draganski, Ph.D., Zylö’s head of product development and adjunct professor at Clemson University; the primary collaborator is Kelvin Davies, Ph.D., professor of urology and professor of physiology and biophysics at Albert Einstein College of Medicine.

    Using ~$225,000 of NIH funds from a Phase I award, Zylö demonstrated compelling results in a radical prostatectomy rat model of ED, whereby the cavernous nerve of the rat is surgically severed such that the rat is sexually dysfunctional and does not respond to sildenafil (a.k.a. Viagra®) and other PDE5 inhibitors. With a single topical application of the nitric-oxide-releasing Z-pod™ formulation, the rats experienced 2.0 erections on average during the 60-minute observation period immediately following topical administration; when the rats were pre-dosed with a 1/10th human-equivalent dose of sildenafil/Viagra, the average number of erections increased to 4.6 and the time-to-initial-erection was approximately cut in half.

    The goal of this Phase II work is to (i) test other PDE5 inhibitors (Cialis®, Levitra®, Stendra®), (ii) scale-up the manufacturing process and to overlay a cGMP quality program, (iii) conduct certain toxicity testing required for an Investigational New Drug [IND] application, and (iv) hold a pre-IND meeting with the FDA to secure feedback critical to successful development of the program.

    If eventually approved, this Z-pod™-based drug candidate will target two distinct market segments, as follows:

    1. Men with ED secondary to radical prostatectomy: It has been reported that 86% of men that have undergone radical prostatectomy (which typically impacts the cavernous nerve) will suffer from ED, with no approved treatment available to them (just like with rats with severed cavernous nerves, these men do not respond to Viagra et al.)
    2. Men with the more typical ‘age-related’ ED symptoms that either do not respond well to the PDE5 inhibitors or cannot take the medication due to medication side-effects or drug interactions.

    In the U.S. alone, these two market segments represent an addressable market of over $2 billion per year.

    Andrew Draganski Ph.D. commented, “Zylö’s nitric-oxide technology is a potential breakthrough in the treatment of ED in men that are refractory to the PDE5 inhibitors such as Viagra. This commitment by the National Institute of Diabetes and Digestives and Kidney Diseases is quite validating, and we are grateful to the NIDDK for their funding.”

    Added Jay Blankenship MD, Zylö’s head of business development, “We are enthused by the opportunity afforded by the NIH to advance our innovative approach to delivering nitric oxide through topical administration. This patent-pending technology holds great promise not just for ED, but for a myriad of other clinical applications such as wound-healing, atopic dermatitis, gingivitis, and sports recovery.”

    About Zylö Therapeutics: Zylö has developed the Z-pod™ technology platform, a disruptive topical delivery system that extends the duration of effect, improves the solubility/targeting, and enhances the product performance of many therapeutic and cosmetic agents. Notably, the Z-pod™ technology has successfully harnessed the therapeutic potential of nitric oxide, one of the most powerful—and short-lived—biomolecules produced by our bodies. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies). 

  • sam patrick posted an article
    DPX earns SBIR grant see more

    DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.

    RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.

    DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.

    The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*

    * Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/

    About DPX Technologies

    DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.

  • sam patrick posted an article
    Learn about South Carolina Life Sciences Feb. 20! see more

    Industry subject matter experts to cover what businesses need to know

    about life sciences, South Carolina’s fastest-growing industry segment

     

    GREENVILLE, SC – February 4, 2019 – SCBIO will host a full day program February 20, 2019 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.

    To be held at the University of South Carolina’s Alumni Center in Columbia, the program will run from 8:30 a.m. until 4:30 p.m. and will feature a light breakfast followed by presentations from over half a dozen noted life sciences industry leaders.  Confirmed presenters and their topics are:

    • Tushar Chikhliker, Partner, Nexsen Pruet, “Pharma Industry Challenges Opportunities & Legal Insights”
    • Kathy Phlegar, Principal, Phlegar & Associates, “Product Development and Commercialization: The Changing  Landscape of Bringing MedTech Products to Market”
    • Maureen Thomas, National Institute on Aging/National Institutes on Health, “Early Stage Funding:  Accessing SBIR-STTR Capital”
    • Erica Jackson, Partner, K&L Gates, “Navigating the FDA: An Overview of Medical Product Approvals and Enforcement Trends”
    • Dave McGlashan, Life Sciences Team Architect, DPR Construction, “Optimizing Capability & Efficiency in Your Life Sciences Facility”
    • Darralyn Alexander, President, Reimbursement Strategies – “How To Gain Reimbursement For My New Technology”
    • Sam Konduros, President & CEO, SCBIO – “South Carolina Life Sciences 2019:  A Look Forward”

    SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations pay only $50 for the entire day.  Individual Members of SCBIO pay only $50 for the entire program, while the general public and Non-Members can attend for just $125.  To register or for more details, visit the Events page at www.SCBIO.org/.

    An additional highlight of the day’s program on “Early Stage Funding:  Accessing SBIR-STTR Capital” will be when presenter Maureen Thomas is joined for discussion and open Q&A by Tyler Tatum and Ron Gorman of 3PhaseSC – South Carolina’s only free resource for SBIR/STTR grant consulting.  Attendees may also schedule 1-on-1 time for afternoon discussion with Ms. Thomas between 1:15 PM and 3:30 PM for more detailed conversation and guidance.

    SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.

    SCBIO is also the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations.  SCBIO’s diverse membership is leading research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.

    For additional information on SCBIO, visit www.SCBIO.org.