In this Entrepreneur Spotlight, we highlight KaloCyte, a company transplanted from St. Louis, Missouri now located in Baltimore at the University of Maryland BioPark.
KaloCyte is developing a solution for when blood is not available. They have demonstrated proof of concept for ErythroMer™, a dried, bio-inspired artificial red blood cell substitute envisioned for use as an oxygen carrier when stored red blood cells are unavailable, undesirable, or in short supply.
For this feature, we interviewed Elaine Haynes, President and CEO, who has 30 years of healthcare leadership expertise and extensive experience with the commercial development of complex pharmaceuticals on the vision she sees for KaloCyte.
What inspired you to join the team at KaloCyte?
After a long career in the pharmaceutical industry, the opportunity to transition to and lead a start-up organization developing a product with the potential to have a huge positive impact was highly inspirational. From the beginning, and even more so today, I like the science, and truth be told, the complexity of the challenge. We are a small team yet part of a very large and important mission, developing and producing a solution that solve a critical unmet need in health care.
The need for blood is constant and minutes matter in blood replacement. How can KaloCyte help save lives?
ErythroMer will be able to be used following trauma when patients have an urgent need for blood. The leading cause of preventable death after trauma is blood loss, with 30,000 people dying annually in the U.S. from otherwise survivable injuries because they are not getting lost blood replaced quickly enough. Our goal is to provide a universal option, meaning compatible with all blood types, that is a lifeline from the point of injury in a pre-hospital setting until a patient can get to a higher echelon of care.
Previous attempts to develop a blood replacement have failed. How is KaloCyte’s approach different?
Our product is specifically designed to address the limitations of previous attempts to develop an artificial oxygen carrier, learning from those who went before us to implement an innovative design inspired by the biology of native cells. Just like a normal red blood cell, ErythroMer captures oxygen in the lungs and releases it to tissues. Our bio-inspired design also protects the encapsulated hemoglobin from causing the severe adverse effects that were the downfall of prior attempts. The biggest game changer is ErythroMer can be freeze-dried, which will enable it to be stored as a shelf-stable dry powder without refrigeration in areas like ambulances, medevacs and in remote settings, providing long-term storage at point of need.
How has the move to Baltimore, Maryland, benefited KaloCyte?
ErythroMer is now being tested for safety and efficacy in our labs in partnership with our co-founders at the University of Maryland. Having our research and business operations co-located within a wider university system where we can tap into talent, resources and potential partnerships has been invaluable. Going into our second year here, I cannot say enough good things about the warm welcome we have received from the ecosystem and the helpful collaboration that has come from so many sources. It’s not a secret that there are several success stories in the area that we can learn a lot from, and I take full advantage of that. Last but certainly not least is the proximity to our potential and existing funders and key stakeholders like the U.S. Food and Drug Administration, the National Science Foundation, the NIH’s National Heart, Lung, and Blood Institute Small Business Program along with the U.S. Department of Defense Army Combat Casualty Care Research Program.
What has been your favorite part of Maryland so far?
Crab cakes – if they are on the menu, I order them! In addition to my crab cake tour, I’ve enjoyed exploring the area restaurants and farmers markets; as a “foodie” I’ve embraced all of it! Before settling down in the rolling hills of the horse country, I lived briefly in the Inner Harbor and thoroughly enjoyed exploring the city. It’s been great getting to know a new part of the United States that is steeped in our nation’s history along with quick access to the coast and major cities. Coming from the Midwest, I appreciate the similar climate and collaborative environment.
What is next for advancing KaloCyte?
It is important for us to continue to systemically de-risk the development of ErythroMer while in parallel we scale up and optimize our manufacturing. In collaboration with KaloCyte co-founders Dr. Allan Doctor and Dipanjan Pan, Ph.D. and the University’s Center for Blood Oxygen Transport and Hemostasis (CBOTH), we are exploring the potential use of the artificial red blood cell to improve oxygen transport for COVID-19 patients. I am also preparing the company for the launch of its Series A round in early 2021, to sustain our efforts towards bringing ErythroMer to first-in-human clinical trials within three years.