KaloCyte’s experimental synthetic red blood cell product ErythroMer could provide a solution to the high need for treating trauma in both military and civilian settings. The company was tapped to participate in a federally-funded program to develop a synthetic blood substitute. The Baltimore-based company is one of a dozen companies and universities selected to partner with the Defense Advanced Research Projects Agency (DARPA) to develop “a field-deployable, shelf-stable, whole blood equivalent” that can be used to treat trauma patients when donated blood is not available. KaloCyte, along with the University of Maryland, Baltimore and other private and public organizations will support DARPA’s Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP) program.
The primary problem the FSHARP program, first announced in 2021, aims to solve is whole blood’s dependence on cold chain and resupply issues. Under the program’s umbrella, KaloCyte and other partner organizations will integrate their bio-artificial and synthetic components to address DARPA’s goal. According to the government agency, the FSHARP members will “evaluate efficacy and safety in increasingly complex and realistic trauma models.” Beyond that, the FSHARP members will develop strategies to stabilize the products without the need for cold storage and scalable manufacturing methods.
“This partnership with DARPA is highly complementary to our work,” Elaine Haynes, President and Chief Executive Officer of KaloCyte said. DARPA will provide $46 million in funding to KaloCyte and the other FSHARP members to support development of the synthetic solution.
KaloCyte, currently housed at the University of Maryland, Baltimore campus, is developing a synthetic approach that mimics the biology of native red blood cells that can be freeze dried and stored for long-term use. Haynes joked that it will almost be as simple as “just add water” when the blood product is needed.
There have been other attempts to develop synthetic blood but they came up short in clinical testing, Haynes said. She believes the company’s experimental product, dubbed ErythroMer, will be different.
ErythroMer is a dried red blood cell substitute that can be easily transported and rapidly administered to patients when perishable donor blood is unavailable. Haynes added that ErythroMer is capable of transporting oxygen just like native cells, which will significantly benefit trauma patients who use the product.
ErythroMer is expected to enter in-human testing within the next two years. The company is in the midst of a Series A financing round. The funds are expected to support IND-enabling studies. Since the company is only using hemoglobin in its product, Haynes said ErythroMer will be universal, meaning agnostic to an individual’s blood type.
“Not only is it universal for patients, it can also be accepted by patients who do not accept donor blood due to religious or other reasons,” Haynes said.
The preclinical work currently being conducted has been promising, Haynes said. The company has seen safety and efficacy in small animal models, such as rodents. KaloCyte will evaluate ErythroMer in larger animals before moving into humans.
“It’s really important that our product works well in complex animal models,” she said.
The partnership with DARPA is complementary to KayloCyte’s ongoing research, Haynes said. The FSHARP project will help accelerate the development of ErythroMer as a standalone project, she added.
There is a significant need for a shelf-stable, instant blood solution such as KaloCyte’s ErythroMer. During the COVID-19 pandemic, the medical community experienced a significant shortage of available blood. Donations were down due to strict lockdown procedures.
While the supply is increasing in the waning days of the pandemic, Haynes pointed to the increasing number of mass casualty incidents across the nation, specifically mass shootings, that can overwhelm the available blood supply. It is estimated there are more than 30,000 preventable deaths each year in the United States that are associated with blood loss following trauma.