Medical Device Daily National Editor
NanoMedical Systems (NMS; Austin, Texas), a startup company co-founded by Mauro Ferrari, PhD, of the University of Texas Health Science Center at Houston (UTHSC-Houston), reported receiving a $3.5 million Commercialization Award through the Texas Emerging Technology Fund (ETF).
NMS is developing an invention of Ferrari's, an under-the-skin drug delivery system intended to improve the effectiveness of anti-cancer agents and other medications. Ferrari is deputy chairman of the Department of Biomedical Engineering, a joint venture between UTHSC-Houston, the University of Texas at Austin and the University of Texas M. D. Anderson Cancer Center (Houston).
Called a Personalized Molecular Drug-Delivery System (PMDS), the device is being designed with thousands of "nano-channels" which control the release of medicine into the bloodstream over a period of weeks or months.
Ferrari told Medical Device Daily that the strategy is to deliver drugs "in such a way that you will get efficacy, but with a great reduction in the side effects."
As the opposite comparative example, he noted the use of interferon, "a great drug, but every time you get a shot of it you feel sick, like a dog," and these shots are often given two to three per week. The result, he noted, is reduced quality of life and often the abandoning of therapy by the patient.
Besides minimizing side effects, he said that the PMDS will provide "lower amounts [of drug] for a longer period of time," improving their benefit. A key application, he said, would be treatment of prostate cancer, with the PMDS intended to "keep the cancer in check for a long time [with drugs] in very small amounts."
The device's "architecture," he said, consists of the device's nano-channels matched to the basic molecule size of the drug and so controlling the rate of "transport," that is, delivery.
The PMDS can be implanted with just a quarter-inch incision in an office setting, Ferrari said.
Randy Goodall, company CEO and co-founder, told MDD that NMS was launched last year with $4.2 million in angel funding. The ETF grant might take the company through clinical trials, with the company matching the device with an approved drug – "that we're not going to name right now," Goodall said – and, to speed approval, not requiring any reformulation.
The company's R&D activities over the next year will include further design and testing of the device's chip and capsule, animal studies and regulatory applications to the FDA. The company will likely need additional funding, he said, to ramp up commercialization.
NMS was one of six companies that received the ETF awards, announced by Texas Gov. Rick Perry last month.
Wayne Roberts, associate VP for public policy at the UTHSC-Houston, said he believed that the $3.5 million grant is the largest commercialization award to a private company in collaboration with a university for product development awarded from the emerging technology fund to date.
The ETF, a $300 million initiative created by the State of Texas, also offers Research Superiority Acquisition Awards designed to bring, the fund said, "the best and brightest researchers in the world to Texas."
Ferrari was recipient of a $2.5 million Research Superiority Award in 2006. Besides various prestigious university appointments and affiliations, he is president of the Alliance for NanoHealth (Houston).
In other grant news, EpiVax (Providence, Rhode Island), a company in the field of computational immunology, reported that it has received a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health (NIH), to optimize delivery of an HIV vaccine.
NIAID will provide EpiVax with $390,000 over two years for the proposed research.
Using the grant funding from the NIH, EpiVax will develop a pro-inflammatory and non-tolerogenic HIV vaccine delivery system based on the dendritic cell targeting anti-DEC-205 antibody.
The success of anti-DEC-205 as a vaccine carrier is dependent on co-administration of non-specific dendritic cell maturation factors such as CD40-ligand. In their absence, anti-DEC-205 induces antigen-specific tolerance rather than immunity.
EpiVax believes that regulatory T-cell epitopes contained in anti-DEC-205 promote a tolerogenic reaction that is only overcome through the coadministration of clinically dangerous or untested non-specific immuno-stimulators. This idea is based on its discovery of a set of natural regulatory T-cell epitopes derived from human immunoglobulins that induce tolerance by stimulating regulatory T cells.
EpiVax said it already has verified experimentally that these epitopes cause antigen-specific expansion of regulatory T cells and suppress inflammatory immune responses.
The NIH award will enable EpiVax to develop a modified pro-inflammatory and non-tolerogenic anti-DEC-205 antibody. Modification of regulatory T-cell epitopes is expected to significantly diminish tolerogenicity, enabling use of anti-DEC-205 as a stand-alone HIV antigen delivery system that obviates the dangers associated with non-specific activation of the immune system.
Epitope modification is an immunomodulatory approach EpiVax previously developed to reduce immunogenicity of protein therapeutics. Here, EpiVax will substitute key amino acids in the regulatory T-cell epitopes with those that are experimentally shown to interfere with MHC binding to reduce tolerogenicity.