Emtora Biosciences

Emtora Biosciences is a clinical-stage biopharmaceutical company focused on developing a novel formulation of the drug rapamycin, trade named eRapa™, for the prevention and treatment of cancers and other age-related diseases. The company was founded in 2009 as Rapamycin Holdings, Inc., and rebranded to Emtora Biosciences in February 2019 to better reflect its core focus on its mTOR-targeted drug.

The foundational technology for eRapa™ was developed in 2009 by Dr. Z. David Sharp and Dr. Randy Strong at the Barshop Institute for Longevity and Aging Studies at UT Health San Antonio. The technology was exclusively licensed to the company in late 2012. In February 2019, Carole Spangler Vaughn, Ph.D., MBA, was appointed CEO, succeeding Dan Hargrove. Dr. Spangler Vaughn brings over 25 years of experience in the life sciences sector, with a background in biophysics from The Johns Hopkins University and business from the University of Washington, having held roles at Bristol-Myers Squibb, Dendreon Corporation, and as a consultant for Emtora prior to her CEO appointment.

Emtora’s business model centers on the clinical development and commercialization of eRapa™ through the 505(b)(2) regulatory pathway, which allows for an expedited approval process by the FDA. The company’s revenue generation will depend on the successful commercial launch of eRapa™ and potential licensing or partnership agreements. A significant development occurred in April 2024, when Biodexa entered into an exclusive license agreement for eRapa™. The company actively seeks non-dilutive funding and has secured substantial grants from the Cancer Prevention and Research Institute of Texas (CPRIT), including a $3 million grant in 2019 and a $16.9 million grant in 2022 to fund clinical trials.

The company's lead product, eRapa™, is a proprietary, micro-encapsulated formulation of rapamycin designed to improve upon the drug's limitations, such as low bioavailability and inconsistent patient response. This formulation protects the active ingredient from stomach acid, allowing for targeted delivery to the intestines, which enhances absorption by approximately 30% compared to generic rapamycin and reduces the need for therapeutic drug monitoring. Emtora is initially targeting indications with significant unmet medical needs. Key areas of investigation include Familial Adenomatous Polyposis (FAP), a rare genetic disease that predisposes patients to colon cancer, for which eRapa™ has received Orphan Drug Designation from the FDA. Clinical trials are also underway for non-muscle invasive bladder cancer and low-grade prostate cancer. The company's pipeline is supported by preclinical data showing eRapa's ability to suppress cancer and rejuvenate the immune system in animal models.

Keywords: Emtora Biosciences, eRapa, rapamycin formulation, clinical-stage biopharmaceutical, cancer prevention, mTOR inhibitor, Familial Adenomatous Polyposis (FAP), non-muscle invasive bladder cancer, prostate cancer, Carole Spangler Vaughn, Z. David Sharp, Randy Strong, UT Health San Antonio, CPRIT, Biodexa, orphan drug, 505(b)(2) pathway, immuno-oncology, chemoprevention, age-related diseases, encapsulated rapamycin