SAN ANTONIO: Emtora Biosciences, a San Antonio, Texas-based clinical-stage biopharmaceutical company been awarded a $16.9M non-dilutive grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to advance the clinical and product development of its lead program, eRapaTM, an encapsulated form of rapamycin, for the treatment of Familial Adenomatous Polyposis (FAP).
Emtora was previously granted $3M under a Seed Award from Cancer Prevention & Research Institute of Texas (CPRIT) in 2019. The Seed Award is being used to complete an ongoing and fully enrolled multicenter Phase 2 trial of eRapaTM in FAP, for which primary endpoint data are expected in January of 2023.
FAP is a rare genetic disease involving mutation of the autosomal dominant APC gene. Patients with FAP are predisposed to the development of hundreds or even thousands of polyps in their gastrointestinal tract. If left untreated, FAP polyps commonly progress to colorectal cancer.
There is currently no approved therapeutic option for the treatment of FAP. The only preventive option that exists is surgical and involves resection of the colon and/or rectum. There remains significant unmet medical need for a safe and effective therapy to treat FAP polyps and impede their progression to colorectal cancer.
Emtora plans to use the CPRIT award to complete a multicenter, randomized, placebo-controlled Phase 3 trial of eRapaTM in patients with FAP. The company believes the successful completion of the planned Phase 3 study will support the approval of eRapaTM under a 505b2 pathway.
The CPRIT award requires a certification of 50% matching funds from external sources. Emtora is currently exploring fundraising and partnering options to secure the required matching funds (initially for Year 1 of the grant) to drive eRapaTM to approval. The company is separately conducting a grant-funded multicenter, randomized, placebo-controlled Phase 2 trial of eRapaTM in patients with Non-Muscle Invasive Bladder Cancer, with data expected in 2024.
Emtora Biosciences is a clinical stage biopharmaceutical company headquartered in San Antonio, Texas. The company is developing eRapaTM, an encapsulated formulation of the previously approved rapamycin, for the treatment of rare genetic diseases and cancer. Emtora’s lead indication is Familial Adenomatous Polyposis (FAP). The ubiquitous mTOR protein, involved in multiple signaling pathways, is overexpressed in FAP polyps. eRapaTM is a potent mTOR inhibitor believed to provide several significant advantages over rapamycin including: targeted delivery to the site of active disease (in addition to systemic exposure); reduced toxicity and improved tolerability; consistent pharmacokinetics (potentially eliminating the need for drug level monitoring) and improved bioavailability. eRapaTM was originally developed at University of Texas Health San Antonio and is currently the subject of two ongoing and grant-funded Phase 2 trials. www.emtorabio.com
About the Cancer Prevention and Research Institute of Texas
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has also recruited more than 281 distinguished researchers to Texas, supported the establishment, expansion or relocation of 51 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided over 8.1 million life-saving cancer prevention and early detection services to Texans in all 254 counties.