Nanotherapeutics has been awarded a U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) contract worth $4.8 million over 18 months to support further development of its orally administered diethylenetriamine pentaacetic acid (DTPA) chelating agent, for the short-term treatment of exposure to americium, curium, or plutonium radiation.
The firm says the contract will support both formulation and manufacturing process development activities and could potentially be extended for up to five years and a total of $31.1 million in funding. “This is the first contract BARDA has awarded for the advanced development of an oral chelating agent to treat internal radiation contamination, and represents a milestone for our program,” comments the authority’s director Robin Robinson, Ph.D.
Announcement of the Nanotherapeutics contract comes just a day after BARDA confirmed it had awarded $56.3 million in total to five other programs centered on developing drugs against radiation exposure.
FDA-approved formulations of DTPA need to be administered intravenously or by nebulizer, whereas Nanotherapeutics’ NanoDTPA is being developed as an oral capsule formulation. The project has been funded with federal funds from the NIAID, BARDA, and the Department of Health and Human Services. In August 2010, the firm filed an IND application with FDA, and in June this year NanoDTPA was awarded orphan drug status.
NanoDTPA is one of a number of products in Nanotherapeutics’ pipeline being developed for chemical, biological, radiological, and nuclear (CBRN) medical countermeasures, based on its inhalation, nasal, injectable, and oral particle delivery systems. Its NanoDRY™ process has been developed to enable the production of nano- or microparticles of low molecular-weight compounds, peptides/proteins, and DNA, in combination with several excipients and polymers. NanoCOAT™ is a solventless microencapsulation system for coating micron and submicron size powders. The NanoQUAD® cryomilling process has been developed to generate particles that are typically under 100 nm in diameter, to generate a powdered drug substance with improved dispersion and absorption properties.
The firm’s clincial-stage pipeline includes in-house and federally funded preclinical and clinical-stage candidates for the treatment of cancer and CNS disorders, along with viral vaccines, anti-infectives, and the NanoDOX™ wound-healing candidates. NanoGENT™ is an inhaled dry-powder formulation of gentamicin in preclinical development against two aerosolized Category A bioterrorism agents; NanoFOVIR™ is a preclinical-stage inhaled dry-powder formulation of the antiviral drug cidofovir; and NanoBUP™ is an early-clinical-stage oral fine particle formulation of buprenorphine for the treatment of opiate addiction. A nasal dry-powder vaccine candidate GelVAC™ is in early clinical development against influenza and in preclinical development against typhoid and norovirus. An oral capsule formulation of GelVAC is separately in development against HIV.