Nanotherapeutics developing oral radiation remedy, hopes to build manufacturing plant in Alachua.
In something like the happy ending of a Hollywood thriller, a local biotech company is developing a pill to treat people exposed to radiation from a dirty bomb or a nuclear accident.
But it’s not from a movie, and neither is the Alachua company’s goal of bringing millions of dollars and many jobs to the area by going after large government contracts.
Nanotherapeutics is developing an oral radiation antidote, a step forward from treatments that must be administered intravenously—making them impractical in a mass casualty event—under a new federal contract that may eventually bring the company more than $30 million.
In September, the Department of Health and Human Services awarded Nanotherapeutics an 18-month, $4.8 million contract to refine the radiation antidote. If all goes well, it could be extended for up to five years and up to $31.1 million under an anti-terrorism division of HHS.
Since its founding 12 years ago, Nanotherapeutics has successfully competed for other government sponsored contracts and has established an excellent reputation due to its scientific expertise and past performance.
“We are very pleased that BARDA, HHS’s Biomedical Advanced Research and Development Agency, chose Nanotherapeutics to develop this important medical countermeasure. The award demonstrates BARDA’s continuing confidence in Nanotherapeutics,” said Gary Ascani, vice president of business development for Nanotherapeutics.
Over the past several years, the company has focused on meeting the U.S. government’s need to develop safe, effective medical countermeasures against certain biological and radiological threats.
“Many of our diversified products have multi-indication or ‘dual-use’ potential in the areas of anti-infectives, central nervous system diseases, oncology, vaccines, treating blood disorders and biodefense,” said Ascani.
Nanotherapeutics’ long-range goal is to build a first-class manufacturing facility in Progress Corporate Park located in Alachua, where the company is headquartered, according to Ascani. It’s what the company hopes to do, he added.
The University of Florida Foundation owns 225 acres close to the Progress Corporate Park, and Nanotherapeutics is considering that land as part of its long-range planning, municipal officials have told the Business Report. The foundation has applied for an amendment to the City of Alachua’s comprehensive plan to develop the 225 acres for corporate park use.
Bruce Delaney, the foundation’s real estate director, says he cannot confirm whether Nanotherapeutics has any interest in the land but said the foundation wants to get the 225 acres ready for development, regardless of its use.
The radiation pill project is using particle engineering—the science of miniaturization of material to fine powders—to develop anti-radiation pills that can be absorbed by the body to replace injections. NanoDTPA, the company’s trademark for the product, is in a class of compounds called “chelating agents.” The compound is being developed to bind radioactive particles that enter the body. Once the chelating agent binds the radioactive particle, it forms a complex that is excreted in urine, thus minimizing damage to the body’s tissues and organs.
The work is a milestone in protecting against dirty bombs—devices that use an explosive to disperse radiation—because pills can be distributed quickly if mass radiation exposure occurs, federal officials say.
“We have a sense of urgency because the drug generally is administered intravenously, so it can’t be administered to a mass of people quickly,” says Robin Robinson, director of the Biomedical Advanced Research and Development Authority at HHS, which awarded the Nanotherapeutics contract.
The HHS contract funds refinement of the radiation antidote. “Most of our projects go the full five years,” Robinson says. If the Nanotherapeutics project goes very well, production of the pills could begin before the end of the five years. “We hope for the best but plan for the worst,” Robinson says.
Under the contract, the company will improve the manufacturing process for its formulation of the drug known as DTPA. DTPA generally is given intravenously or by a nebulizer, which hampers treating a mass of people, Robinson says.
DTPA works as a chelating agent for people exposed to americium, curium or plutonium, binding to radioactive molecules to help the body remove them. Other drugs, including potassium iodide tablets and Prussia blue, a product that painters use, are employed against other forms of radiation exposure.
“Nanotherapeutics is doing a really good job with unique cutting-edge technology, and we’re happy to be working with them,” Robinson says.
In June, the FDA awarded orphan-drug status to NanoDTPA, a designation that refers to drugs that treat a relatively small amount of people.
Nanotherapeutics is also investigating using NanoDTPA as a way to treat iron overload, which results from repeated blood transfusions for treatment of Sickle Cell Disease and two other diseases, the company says.
Nanotherapeutics Has Rich Pipeline
Nanotherapeutics went into business in 2000 and was a tenant of the Sid Martin Biotechnology Incubator. Since then, the company has moved to bigger space in the Progress Corporate Park and has grown to 45 employees, says Patti Breedlove, the incubator’s associate director.
Co-founder Jim Talton, who holds a doctorate in pharmaceutical sciences and a master’s and bachelor’s in materials science and engineering from the University of Florida, continues to lead the company today.
“Jim was the youngest CEO in our program,” Breedlove says. “He has expanded steadily and is providing high wage, clean jobs that contribute to the area’s economy,” Breedlove says.
Meanwhile, Nanotherapeutics recently announced that it had successfully completed phase one clinical trials of a nasal flu vaccine. The vaccine is stored as powder, which turns into a gel after it is sprayed into the nose. The vaccine has the advantages of being able to be stored at room temperature and being administered without an injection, according to a Nanotherapeutics news release.
Other products that Nanotherapeutics is working on include:
- An inhaled smallpox vaccine that it is developing under a $30.9 million contract with the National Institute of Allergy and Infectious Diseases.
- Two drugs—one that treats a form of leukemia and one that treats cervical and vaginal cancers—that it acquired through purchases.
- A drug for treatment of opioid addiction.
- Drugs used to develop inhaled versions of gentamicin, an antibiotic used to treat various respiratory diseases, which the company is developing under a $20 million federal contract.
- A topical form of the antibiotic doxycycline, which it is developing in collaboration with the Walter Reed National Military Medical Center, the Henry Jackson Foundation and the Diagnostic and Translational Center under a Defense Department contract.