The next big medical breakthrough may start in a small business with a big idea. Recognizing the potential and promise of early-stage companies for addressing unmet medical needs, the BIO International Convention will once again host the Innovation Zone on the exhibit floor of the San Diego Convention Center, June 19-22. Eighty emerging companies will showcase biotechnology breakthroughs in drug discovery, diagnostics, and other therapeutic platform technologies.
The Innovation Zone was created through a partnership with the National Institutes of Health (NIH) and the National Science Foundation (NSF) with the intent to group Small Business Innovation Research (SBIR)-funded companies together on the exhibit floor of the BIO International Convention. The SBIR program provides U.S. federal funding to small businesses engaged in research and development with demonstrated potential for commercialization. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding.
Today we spoke with Innovation Zone exhibitor, John McGonigle, Business Development Associate at NuvOx Pharma, which is supported by NIH’s SBIR program.
BTN: What is your company’s lead product or technology?
NuvOx Pharma is developing a nanotechnology platform of therapeutics to treat life-threatening diseases characterized by hypoxia. The Company has clinical programs in cancer (Phase II), stroke (Ib/II) and sickle cell disease (Phase Ib).
BTN: How has the NIH’s SBIR program helped your company grow?
The NIH’s SBIR program has been instrumental in the development of NuvOx Pharma. For example, our oncology program was started by an NCI SBIR Phase I grant to help us reformulate an EMEA approved ultrasound contrast agent as a stable emulsion for oxygen delivery. A Phase II NCI SBIR grant supported IND enabling animal studies, and helped us show that the drug can raise tumor oxygen levels to make tumors more sensitive to radiation therapy. We completed a Phase Ib/II clinical trial in brain cancer, and the FDA has allowed our IND for a Phase II clinical trial in this indication. We have applied to the NIH for a Phase IIb SBIR Bridge Award, which would match investor funds to support the Phase II clinical trial. In addition, the Company has received Phase I SBIR/STTR grants to develop nanotechnology products for heart disease (endocarditis and myocardial infarction) and cancer (pancreas and breast).
BTN: What are the upcoming milestones and long-term priorities for your company?
Long term, we recognize that hypoxia can be life-threatening in many medical conditions, including some of the biggest killers in the world such as cancer, stroke and heart attack. We intend to save lives by using our nanotechnology to deliver oxygen to hypoxic tissue more effectively than red blood cells. We have animal data showing improved outcomes in cancer, stroke, myocardial infarction, sickle cell disease, hemorrhagic shock, and traumatic brain injury.
Short term, we have several major milestones coming up in the next year. We are on track to start the Phase II clinical trial in oncology this fall. We have an active Phase Ib/II clinical trial in stroke and we should have the first randomized data from that trial within the year. We are on track to start a Phase Ib clinical trial in sickle disease this summer. The NHLBI has recently funded a study in heart attack in pigs, which could provide the data needed to file an IND for a clinical trial in that indication.
BTN: What do you hope to gain out of your participation at the 2017 BIO International Convention?
We are seeking investors to help us develop our drug assets and corporate partners to help us develop our nanotechnology products.
BTN: Tell us something about your company that investors might not know…
$100M was spent developing the core technology for a diagnostic indication – as an ultrasound contrast agent. It was used in 2,200 patients, and approved in Europe, but never marketed due to competitive pressures. NuvOx was formed to reposition the technology for its oxygen delivery ability. We have devised new formulations with the support of the NIH. We have tested the nanotechnology products in multiple models – oxygen delivery and/or therapeutic effect has been shown in 26 peer-reviewed publications, many of which were supported by NIH funding, in particular by the NCI and NHLBI. We have expanded the IP – and have 5 patents issued, 1 patent allowed and 12 patents pending. The FDA regulates the technology as a Biologic, allowing 12 years exclusivity for a first in class indication – and we are the only technology in clinical trials in our class. We would like to thank the NIH for its forward-thinking and continued support. Feel free to stop by NuvOx Pharma’s kiosk in the NIH’s Innovation Zone at BIO San Diego if you would like to learn more.