Next month in San Diego 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 first-ever 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. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding. The majority of participating companies in the Innovation Zone have received SBIR Phase II grants, which provide up to $1 million dollars in funding to engage in R&D that has the potential for commercialization.
Over the new few weeks, we will feature snapshots of a few of the companies who will participate in the Zone. Today, we interviewed Michael Kaytor, the director of R&D of Minneapolis, Minnesota-based Humanetics Corporation, a small business supported by NIH’s SBIR program.
What is your company’s lead product or technology?
Humanetics’ lead candidate is BIO 300, an oral suspension of genistein nanoparticles. Genistein’s efficacy as a radiomodulator was discovered, validated and patented by researchers at the Armed Forces Radiobiology Research Institute (AFRRI) and the National Institutes of Health (NIH). Humanetics obtained a worldwide exclusive license to develop genistein under these patents. We established material collaborations to develop BIO 300, and have received funding from the Department of Defense (DoD), the Biomedical Advanced Research and Development Authority (BARDA) within Health and Human Services (HHS), and the National Cancer Institute (NCI). We will commence a Phase II clinical trial on BIO 300 in 2014 to evaluate its safety and efficacy in patients receiving chemoradiation treatment for non-small cell lung cancer.
How has the NIH SBIR program helped your company grow?
The NIH SBIR program has allowed us to broaden the uses of BIO 300 into the field of radiation oncology. This is a critical step in the development of this drug and is very synergistic with our work to develop BIO 300 as a medical radiation countermeasure (MRC) for DoD and BARDA. Capital markets readily understand and value drug candidates with commercial potential, and so moving into the oncology field allows us to attract additional sources of strategic financing to accelerate development of the drug. In addition, the possibility of a near-term commercial use of BIO 300 is viewed favorably by BARDA, which makes our drug more attractive to them to approve funding of full development through FDA licensure. The SBIR contract also allows us to advance BIO 300 into clinical testing, which is otherwise not possible with MRC’s.
What are the upcoming milestones and long-term priorities for your company?
2014 will be a landmark clinical year for Humanetics. We intend to commence our Phase II clinical trial of BIO 300 in patients receiving chemoradiation treatment for non-small cell lung cancer. We are also anticipating a NCI award to fund preclinical studies to evaluate BIO 300’s ability to reduce erectile dysfunction following prostate cancer radiotherapy. Lastly, we anticipate beginning the next phase of our work with BARDA to further develop BIO 300 as a MRC to prevent lung damage from acute radiation exposure.
In addition to our BIO 300 clinical milestones for 2014, we will also complete Phase II clinical studies in Alzheimer’s disease with NIC5-15 and Post Traumatic Stress Disorder (PTSD) with HL-9001.
What do you hope to gain out of your participation at the 2014 BIO International Convention?
Our objective is to present BIO 300 and Humanetics as a specialty pharmaceutical company to potential development and investment partners. We also want to build a network with other NCI SBIR awardees to mutually benefit from our shared experiences.
Tell us something about your company that investors might not know.
Humanetics has three compounds in Phase II clinical trials. All products are in significant markets with urgent and unmet needs. In addition to our Phase II trial in NSCLC with BIO 300, we have a Phase II trial nearing completion with NIC5-15, a compound under investigation to slow down the progression of Alzheimer’s disease. This trial is being conduced at the James J. Peters VA Medical Center in Bronx, NY. NIC5-15 is an insulin mimetic that plays a role in stimulating the glucose cascade in the brain and has been shown to lower levels of beta-amyloid plaques in the brain. Its mechanism may also have a positive effect on reducing hyperphosphorylation of Tau. NIC5-15 has been formulated into a medical food for further pre-clinical and clinical testing.
In addition to NIC5-15, we have another small molecule, HL-9001, in a Phase II clinical trial for the mitigation of PTSD. This trial is being conducted at the Bay Pines VA Healthcare System in Bay Pines, Florida in veterans with drug resistant PTSD. HL-9001 is a natural neuroprotective compound with a mechanism that inhibits the formation of cortisol. Over one hundred case studies have been documented using HL-9001 effectively to control the symptoms of PTSD.