A Medical Device Daily

Spire (Bedford, Massachusetts) reported the receipt of a two-year Small Business Innovation Research Phase II grant of $498,764 from the National Science Foundation (NSF; Arlington, Virginia) to allow its Spire Biomedical unit to continue the development of blood-compatible dialysis catheters, used for the treatment of end-stage renal disease (ESRD) dialysis patients.

Under Phase I of the program, Spire demonstrated through in vitro studies that its proprietary surface treatment reduces the potential for catheter-related thrombosis. The treatment results in a nano-engineered biological coating that combines protein passivation, anticoagulation, and fibriolytic chemistry that is integrated onto an atomically nano-textured surface.

Mark Little, CEO of Spire Biomedical, said, “Vascular access complications cost our healthcare system more than $2 billion annually. Clotting of catheters reduces vascular access potency, requiring intervention and disrupting treatment.“

He added: “Domestically, industry experts estimate that nearly 600,000 hemodialysis catheters alone are sold each year with a market value of more than $100 million. Applying this new technology to dialysis catheters will provide major benefits for physicians, hospital staff, and most importantly, the patients.“

Spire Biomedical offers a full line of chronic hemodialysis catheters. The company also is a major provider of surface engineering technology for biomedical devices.

Spire is a diversified technology company serving the biomedical, solar energy, telecommunications and defense industries worldwide.

IOMAI (Gaithersburg, Maryland), a private biopharmaceutical company, reported the award of a $2.9 million grant from the National Institutes of Health (NIH; Bethesda, Maryland) to help develop a patch designed to improve responses to influenza vaccination.

The grant, titled “Immunostimulatory Patch to Enhance Biodefense Vaccines,“ was made under the National Institute for Allergy and Infectious Disease (also Bethesda) program, Cooperative Research for the Development of Vaccines, Adjuvants, Therapeutics, Immunotherapeutics, and Diagnostics for Biodefense and SARS.

“This support extends our partnership with the NIH in striving to meet the critical needs for protection against influenza,“ said Stanley Erck, president and CEO of IOMAI. “[Our] patch technology has the potential to stimulate stronger responses to both annual flu vaccines, especially in the elderly, and to vaccines developed to combat new, or pandemic, outbreaks of influenza.“

Erck added: “NIH support for our skin vaccination technology signals its potential importance for national health reasons as well as for biodefense applications. The NIH has supported the development of our transcutaneous patch system for vaccine delivery in the past and this current grant will help accelerate the development of these important products.“

Founded in 1997, IOMAI has pioneered the delivery of vaccines to the skin through a technology known as transcutaneous immunization, or TCI. The company is evaluating skin immunization techniques in several human clinical trials, including those to prevent influenza in the healthy adult and elderly populations, and also to prevent travelers' diarrhea and anthrax.

IOMAI has an exclusive worldwide license to TCI and has confirmed the potential of TCI in multiple clinical trials.

Morphotek (Exton, Pennsylvania) reported that it has been awarded a Developmental Project grant from the Network for Translational Research in Optical Imaging Consortium of the National Cancer Institute (Bethesda, Maryland).

The grant was awarded to support research to generate antibodies with enhanced antibody dependent cellular cytotoxicity (ADCC) activity that are derived from genetically evolved cell lines generated using the company's Morphodoma technology.

The scope of the program involves the generation of in vitro and in vivo high throughput assays to screen and identify genetically optimized antibody-producing cell clones yielding antibodies with enhanced ADCC as compared with that of the parental antibody for therapeutic development.

Morphotek has developed a proprietary platform process called Morphodoma technology that can optimize antibody-producing cell lines to yield subclones producing antibodies with higher affinity, enhanced ADCC or cells with enhanced titers for scaleable manufacturing.

Cells are optimized via whole genome evolution using Morphodoma technology, yielding pools of evolved sibs exhibiting target characteristics. The grant supports novel research utilizing high-throughput assays to rapidly detect ADCC activity of antibodies in vitro and in vivo.

“We are pleased to have received this peer reviewed funding for the development of assays that can monitor the ADCC activity of therapeutic antibodies derived using our Morphodoma technology,“ said Nicholas Nicolaides, PhD, Morphotek president and CEO.

“Robust immune-effector function is a key feature of efficacious antibodies being developed to treat many cancers,“ he said. “The combination of our Morphodoma technology along with the ability to rapidly identify optimized antibodies with robust ADCC activity is valuable for the oncology drugs being developed for our internal pipeline as well as for products being optimized for our partners.“

No Comments