BALTIMORE, January 28, 2025 – KaloCyte, Inc., a pre-clinical biotech startup company developing a bio-inspired red blood cell substitute called ErythroMer™, announced today that it has been selected to join Blue Knight, a strategic collaboration between the Biomedical Advanced Research and Development Authority ('BARDA') and Johnson & Johnson’s global incubator network, JLABS, supporting early-stage innovation and incubation of science and technologies to improve health security and unlock new approaches to solving health issues.
KaloCyte, a University of Maryland BioPark affiliate, will be a virtual resident within JLABS, a premier life science incubator program. They will keep their laboratories and offices in downtown Baltimore where they collaborate closely with the University of Maryland School of Medicine’s Center for Blood Oxygen Transport & Hemostasis (CBOTH).
“We are thrilled to join JLABS and the Blue Knight program and look forward to working alongside industry leaders, BARDA, and other Blue Knight companies,” commented KaloCyte President and CEO, Elaine Haynes. “We are at a critical stage, preparing for an investigational new drug filing. The regulatory expertise and guidance available through the Blue Knight community will help ensure our development stays aligned with stakeholder interests.”
Blue Knight is a collaboration dedicated to anticipating public health security threats, activating the global innovation community, and amplifying scientific and technology advancements to respond to a rapidly evolving global health environment.
Blood loss is the leading cause of preventable death after trauma, yet most ambulances don’t carry blood because it is perishable and type-specific, leading to approximately 30,000 potentially preventable deaths each year in the United States alone. Stored donor blood products used to replace lost blood are at times unavailable (pre-hospital care, remote or austere environments, underdeveloped countries), undesirable (risk of immune response), or in short supply to meet demand. KaloCyte is developing ErythroMer™ to bridge this gap and meet this critical unmet need when blood is not available, potentially saving numerous lives.
ErythroMerTM is a novel artificial red blood cell substitute that is freeze-dried and shelf-stable without refrigeration, allowing it to be transported and used in pre-hospital settings as well as stockpiled for use when perishable donor blood is in short supply. ErythroMer™ carries and delivers oxygen from the lungs to tissues, just like natural red blood cells and is a universal option for patients of all blood types. Based on preclinical studies to-date, ErythroMer™ exhibits minimal toxicity and highly efficient oxygen delivery. The product has wide applications for civilians and military field use.
In addition to using ErythroMerTM for emergency transfusions, the KaloCyte team is exploring other uses including transplant organ perfusion, sickle cell crisis, and veterinary use.
“We are fortunate to be located in Baltimore and have such easy access to JLABS DC,” said Haynes. “Center for Blood Oxygen Transport & Hemostasis (CBOTH) is a critical research and development partner for KaloCyte. We are currently working with CBOTH’s academic researchers and a number of other organizations on a significant research project funded by the Defense Advanced Research Projects Agency (DARPA) to develop deployable, shelf-stable, universal whole blood substitute as a hemorrhage countermeasure to sustain injured warfighters in austere, pre-hospital settings. ErythroMerTM will be a core component of this product. Staying physically close to CBOTH’s laboratories will be beneficial for advancing ErythroMerTM as well as developing this potentially life-saving whole blood substitute.”
KaloCyte is supported by $17M in National Institutes of Health and Department of Defense grants and has raised over $5M in investor funding that will support ErythroMerTM development, optimization and testing, positioning KaloCyte to advance to first-in-human trials.
About KaloCyte
KaloCyte is a pre-clinical biotech therapeutic startup company developing ErythroMer, a bioengineered artificial red blood cell (RBC) substitute that can be freeze-dried for long-term storage and is envisioned for pre-hospital treatment of traumatic hemorrhage when stored blood is unavailable or undesirable.
ErythroMer is a universal option for all blood types and has potential for accelerated regulatory pathways to address a critical unmet need serving a $7B U.S. market. To date, KaloCyte has demonstrated proof of concept, safety, and efficacy in animal models. Funded by $17M in grants from DARPA and NIH, and over $5M investor funding, The company is seeking Series A financing to fund IND-enabling studies and Phase 1 clinical trials.