DoD-backed startup targets clinical trials of bio-manufactured red blood cells to address limitations of current donor blood system.
Biotech startup Safi Biotherapeutics has secured $5 million in seed funding to advance its mission to accelerate the production of bio-manufactured red blood cells. The company is developing manufactured blood cells for patients requiring transfusions for a range of chronic conditions, while also exploring the creation of universal donor blood cells for use in acute trauma and surgical settings.
Safi is targeting issues associated with the current donor blood supply system, which it says is vulnerable to shortages. Patients requiring regular transfusions often develop immune responses to multiple blood antigens, complicating the matching process and increasing the difficulty of finding compatible donor blood. In addition, as the global population ages, it is anticipated that the demand for blood donations will rise, while the pool of donors simultaneously diminishes.
Safi’s technology aims to address these challenges by developing red blood cells grown from stem cell sources. While the concept of growing red blood cells in a lab has been explored by researchers for many years, the focus has now shifted to producing these cells in sufficient quantities at a cost that makes them a commercially viable alternative to donor blood.
“We know red blood cells can be grown from stem cell sources; academic and industry teams have been demonstrating this for years,” said Safi CEO Doug McConnell. “There have even been clinical trials with small, teaspoon amounts of cultured RBCs being transfused, including the current RESTORE study out of the University of Bristol in the UK. The challenge has been whether we can make enough of these cells cheaply enough to be viable as a commercial alternative to donor blood. We believe we can.”
Safi was founded in 2020 as part of the US Department of Defense’s On-Demand Blood program, an initiative aimed at advancing blood cell therapy technologies. Safi’s partnership with the DoD has enabled the company to demonstrate the commercial feasibility of producing allogeneic red blood cells at a scale that supports multiple transfusion units.
“The DoD funding has supported the development of high intensity, hyper-efficient production of these cells using reduced amounts of media and a lowered cost of components,” added McConnell. “We now see a path forward for an economically viable mRBC product that can serve both civilian and military needs and augment the existing donor blood supply.”
The new seed investment, led by J2 Ventures, adds to more than $15 million in DoD funding, and is expected to accelerate Safi’s efforts in clinical production and regulatory processes, including the submission of an Investigational New Drug (IND) application and the initiation of clinical trials.
Photograph courtesy of Safi Biotherapeutics