Safi Biotherapeutics—a company launched by former DARPA, Vertex, MIT, and MGH leaders—is leading the development of manufactured red blood cells (mRBCs) as an alternative to donor blood transfusions. The company recently announced a $5 million seed funding round led by J2 Ventures, which complements over $15 million in funding from the U.S. Department of Defense.
While the DoD support has enabled Safi and its government program partners to demonstrate that an mRBC transfusion product is commercially feasible, the seed funding accelerates the clinical production and regulatory path toward IND submission and initial clinical trials. And this also enables Safi to expand its team of cell therapy product development experts and bring in additional regulatory, clinical strategy, and commercialization thought leaders.
Despite the impressive scale and logistical offerings of the donor blood supply system, it is still a fragile network prone to increasing emergency-level shortages of the needed supply.
Patients who need to receive regular transfusions over many months, if not years, such as those with anemia from blood disorders like sickle cell disease or cancer patients undergoing chemotherapy, develop immune responses to many blood antigens and need very specific and challenging to-find matched blood-typed units.
For the military, getting the required blood units closer to the point of need in various locations worldwide presents more challenges. For all these reasons and more, it has become clear that an on-demand, safe, and effective alternative to the donor blood transfusion supply is needed.
This private investment from the J2-led seed round will help Safi deliver on its mission to make biomanufactured blood through a true public-private partnership, catalyzing the manufacturing scale-up, non-clinical studies, and US FDA regulatory activities required to initiate clinical trials for mRBCs at a multi-unit transfusion scale.
KEY QUOTES:
“We know red blood cells can be grown from stem cell sources; academic and industry teams have been demonstrating this for years. 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.”
“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. 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.”
-Safi CEO Doug McConnell
