BIOtechNOW featured IVS’s participating BIO Innovation Zone
Later this month in Philadelphia at the BIO International Convention, BIO will be partnering with the National Institutes of Health (NIH) and the National Science Foundation (NSF) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.
The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.
Today, we spoke with Ayla Annac, the CEO of InvivoSciences Inc. in Madison, WI and Carleton Hsia, the CEO of NanoBlood LLC in Irvine, CA. These two biotechnology companies have been supported by the NIH’s SBIR program.
What is your company’s lead product or technology?
Ayla Annac, InvivoSciences: InvivoSciences (IVS) is a leading developer of proprietary, award-winning platform technologies that creates human 3D cell/tissue culture models and their automated phenotype analyzers for drug discovery and precision medicine development. IVS’s functional 3D tissue models reconstitute the physiological properties of human cardiac, smooth and skeletal muscle as well as connective tissues that support cancer growth. Our lead product is 3D cardiac engineered heart tissues (EHTs) fabricated from human induced pluripotent stem cell (iPSC) derived cardiomyocytes. Applying induced pluripotent stem cell (iPSC) technology, patient-cell derived 3D micro tissues exhibiting hereditary cardiac diseases are mass-produced in micro wells. The live-in-tissue analysisTM (LITATM), ahigh content phenotypic analyzer, quantifies treatment-induced changes in the tissue construct’s physiological function and the bio-molecular activities underlying those changes. IVS offers services using the LITATM for testing efficacy and safety of drug candidates. The LITATM will be available soon for in-house operations at customers’ sites. Dr. Tetsuro Wakatsuki (CSO) of InvivoSciences says” Our human engineered micro human cardiac tissues show long-term viability and contractile function more than 6 months. Thus, this is a critical competitive advantage in the market. Our tissues are reproducible, uniform, have long-term consistent and accurate functionality and responsiveness to cardio-active and cardio-toxic substances and will be an ideal in vitro model for the study of acute and chronic toxicity.” Tailored to represent diverse human populations and specific diseased states, our cardiac tissue model can offer an exceptional ability to predict potential cardiac safety issues and drug efficacy in clinical studies.
While IVS currently focuses on applications of the LITATM in cardiac safety and discovery projects, IVS has plans for developing a wide range of useful applications in treatment development for regenerative medicine, cancer, autoimmune disorders, and a wide range of rare diseases. Our unique combination of tissue engineering technology with assay automation and sample miniaturization offers a rapid and cost effective platform for unprecedented therapeutic discovery.
IVS is addressing a significant, well-recognized but underserved problem with a technology that can effectively fill the gap in the existing large market.
Carleton Hsia, NanoBlood: NanoBlood LLC has developed VitalHemeTM (nanoRBC), an innovative multifunctional neurovascular protective agent for the prevention and treatment of ischemia, reperfusion injury and damaging inflammatory reactions caused by superoxide generation. The leading use of nanoRBC is in correcting insufficient blood flow and oxygen supply in critical care patients and those in need of blood transfusions. In this, nanoRBC is a major breakthrough (after a half-century of failed efforts by many companies) in the development of a safe alternative to RBC transfusion. nanoRBC, also holds great promise for use as a therapeutic in a wide variety of conditions involving the vasculature. Due to its mechanism of action, it may also be of interest to pharmaceutical companies for improving outcomes in treating disease using their own commercialized or pipeline drugs or therapeutic intervention.
nanoRBC in small quantities has been shown in preclinical studies to be superior over fresh blood in preventing ischemic damage and reperfusion injury in critical care situations. It is has been effective in preclinical studies in a broad range of conditions including, hemorrhagic shock, traumatic brain injury, stroke, sickle cell anemia and a host of other conditions. The primary mechanism of action of VitalHeme is dismutation of vascular superoxide, in which it outperforms native superoxide dismutase. Its secondary mechanism is blocking the toxicity of cell-free hemoglobin. By these mechanisms, nanoRBC interferes with the inflammatory reactions and vascular changes that are damaging to the patient.
Based on the success of preclinical studies we suggest that 100% vs 3% of stroke patients will become treatable, ~90% of metastasis of cancers may be prevented and transfusion medicine practices will be 100% transformed globally.
How has the NIH SBIR program helped your company grow?
Ayla Annac, InvivoSciences: The National Institutes of Health (NIH) SBIR program has supported IVS to achieve proof-of-concept studies of drug discovery applications of our innovative technologies in collaboration with major pharmaceutical companies. NIH’s leadership has recognized our invention and its future value at its early phase. This enabled IVS’s scientific team to continue critical proof of concept studies to build a strong foundation for commercialization. Strong scientific data led to the establishment of collaborative strategic partnerships. The funds also created new jobs to stimulate regional economies and support the future growth of the industry segment. The National Federation of Independent Businesses estimates that about two-thirds of the new jobs in recent years have been created by small businesses, and that start-ups including technology base account for a large share of these new jobs.
Without NIH support and the entrepreneurial mechanism of its funding structure, IVS would be only “a dream concept “ in the minds of its three founders. It would not have been able to sustain the business structure essential for its growth and hire a technical team to support the creation of solid data that led to a rich globally competitive IP portfolio. Moreover, without this support IVS would not have been able to attract multiple dynamic collaborations with key industry and academic partners that helped IVS create a rich and diverse product/assay and service portfolio that is designed towards unmet needs of drug discovery, development and patient populations with debilitating diseases. We appreciate NIH’s vision for innovation-based growth economies and its ability to prepare entrepreneurs with commercial guidance under the CAP program. Thanks to the leading efforts of Dr. Lenka Fedorkova, PhD, program manager for NIH SBIR/STTR programs, IVS and hundreds of other biomedical companies can dare to take the path to commercialization of innovative technologies.
Carleton Hsia, NanoBlood: Through NIH SBIR funding, we have successfully completed preclinical studies for a host of targeted medical conditions, in collaboration with leading academic research laboratories and clinicians. The data has been positively evaluated by FDA.
NanoBlood LLC is targeting FDA fast track and breakthrough therapeutic designation to bring nanoRBC to patients in need, and are initiating clinical trials.
As a result of NIH SBIR funding of the parent company Synzyme Technologies (Irvine, California) and the resulting growth and success of its subsidiary Nano Blood LLC to date, NanoBlood LLC has received funding from the Governor’s Office of Economic Development of the State of South Dakota to relocate to and build its commercial GMP manufacturing plant at the USD Research Park in Sioux Falls, SD. nanoRBC and related products will be manufactured there.
What are the upcoming milestones and long-term priorities for your company?
Ayla Annac, InvivoSciences: IVS seeks series A funds from private investors or corporate to enable and support our global commercial growth plans as well as to scale up and fully-automate manufacturing of human engineered heart tissues and their personalized derivatives. Recently IVS received the additional NIH support for a project that aims to develop inherited heart failure models.
Carleton Hsia, NanoBlood: The upcoming milestones and long-term priorities include:
Obtain FDA fast track and breakthrough therapeutic designation to accelerate commercialization
Phase 1 and 2 clinical trials; research collaborations
Ramp-up of the new commercial manufacturing plant in South Dakota
Establishing global partners for commercialization and sales
Company growth to match market expansion
What do you hope to gain out of your participation at the 2015 BIO International Convention?
Ayla Annac, InvivoSciences: During BIO 2015, IVS will be exhibiting under Innovation Zone booth number 101 and seek connection with potential funding partners to share our vision for the global business opportunity. IVS also aims to promote its innovative, cutting-edge technologies, product and service portfolio to potential customers and to form long-term strategic partnerships with pharmaceutical, biotech, CRO and instrument companies worldwide.
Carleton Hsia, NanoBlood: NanoBlood LLC is looking to establish partnerships aimed at speeding the commercialization process and in expanding product validation in new areas. We hope to attract investors as well as companies that may be interested in licensing the technology, including for sales/distribution in global markets.
Tell us something about your company that investors might not know.
Ayla Annac, InvivoSciences: The U.S. Food and Drug Administration (FDA) will most likely amend the current preclinical cardiac safety protocol. InvivoSciences, Inc. is an active member of the cardiac safety technical committee organized by HESI to review new technologies, such as applications of human induced pluripotent stem cells (iPSC) derived cardiomyocytes for improving preclinical cardiac safety assays. Other members of the committee include FDA and most of the global pharmaceutical companies. Please visit us at booth 101 Innovation Zone during BIO 2015. www.invivosciences.com. For further information contact Ayla Annac, CEO aannac@invivosciences.com.
Carleton Hsia, NanoBlood: nanoRBC holds promise for use as a therapeutic in a potentially limitless number of medical conditions. We are aggressively trying to define all the unmet conditions in which nanoRBC might be used, some described above. Another area of important interest is neurological diseases. In a recent preliminary study of an animal model of multiple sclerosis, nanoRBC showed the ability to alleviate neurological deficit. There is every reason to project that this product has uncapped market potential.