ViraCyte has received a combined $3.75 million from the National Institutes of Health and the U.S. Food and Drug Administration to continue developing T-cell immunotherapies for viruses associated with stem cell transplants.
The grants came under U.S. government rare-disease therapy-development programs. Three million dollars came from the National Institutes of Health and $750,000 from the FDA.
ViraCyte will use the larger grant to continue developing a treatment against the BK virus. The $750,000 grant will go toward an immunotherapy against adenovirus. Viralym-A is its therapy for adenovirus, and Viralym-B its treatment for BK virus.
BK virus can cause serious health problems, including a lower urinary tract complication known as hemorrhagic cystitis and acute kidney inflammation, or nephritis. The conditions can lead to bleeding and kidney failure.
Adenovirus can cause severe pneumonia and bowel disease in transplant recipients.
ViraCyte is planning Phase 1 clinical trials of both therapies. If the trials process goes well, the immunotherapies would be the first treatments the FDA has approved for either virus.
“We are very pleased” that the two government agencies “have recognized ViraCyte’s commitment to addressing critical unmet medical needs with these two highly competitive awards,” Ann Leen, ViraCyte’s chief scientific officer, said in a press release. “This is an important milestone towards advancing our T-cell immunotherapy products into pivotal trials.”
The $3 million grant was awarded under the National Institutes of Health’s Small Business Innovation Research program, which supports the development of innovative technologies for diseases that are rare or that strike children. The $750,000 came under the FDA’s Office of Orphan Products Development program. Those grants go to companies developing therapies for rare diseases with either no or limited treatment options.
This year, more than 30,000 people will receive stem cell transplants in the United States and Europe combined, ViraCyte said. More than 10,000 will develop a severe viral infection afterward, it said.