Engineering ex vivo breast tumors in human breast tissue to address racial disparities in HR-/ERBB2+ breast cancer

PROJECT SUMMARY/ABSTRACT Black women are 42% more likely to die from breast cancer than White women. While social, economic, structural, and cultural factors contribute to this disparity, differences in Black and White tumor biology are a major driver. New therapeutics that address these biological differences could resolve the racial disparities in breast cancer survival. Unfortunately, developing new therapeutics is slow, risky, and expensive: despite an average pre-clinical investment of $238 million, 95% of new therapeutics fail FDA clinical trials. Keliomics’ patented, groundbreaking technology is the first that can keep human breast tissue alive in the lab. Using this breast tissue, we can produce breakthrough models of breast cancer for use therapeutic development. Unlike existing technologies, our models can be specific to Black breast cancer, White breast cancer, early breast cancer, and advanced breast cancer. Our long-term goal is to use these models to develop new therapies for these different subtypes of breast cancer. In our Phase I studies, we will identify the specific conditions that will generate models of Black breast cancer, White breast cancer, early breast cancer, and advanced breast cancer. With that accomplished, in Phase II we will perform large, definitive studies of our breast cancer models to show that they respond to chemotherapy in the same ways that human patients do. This will revolutionize therapeutic development for breast cancer by reducing the failure rate and reducing costs. Our target customers, breast cancer therapeutic developers, have 1,000 new treatments in development. We estimate this to be a $1-2 billion market opportunity.