Wednesday, May 28, 2025
5/28/2025
IL-10NanoCap® for Therapy of Familial Adenomatous Polyposis - Abstract This SBIR Phase IIb proposal builds on the success of our Fast-track award supporting the pre-clinical development of FAPXIL, an oral sustained-release micro-particulate formulation of Interleukin-10 for the treatment of Familial Adenomatous Polyposis (FAP). The Phase I portion of our Fast-track project provided validation of our large-batch methods and activity in a clinically-relevant murine model of human FAP. The Phase II segment further optimized the treatment protocol, defined the long-term therapeutic potential and assessed potential effects of long-term treatment on local and systemic immune homeostasis. Additional Phase II tasks included production of multiple scale-up batches for validation of batch-to-batch consistency, long-term stability analysis, transfer of manufacturing methods to a CMO with GMP capability, and a Type C pre-IND meeting with the FDA to inform future toxicology. Agency recommendations and responses to our interrogatives form the Aims of this Phase IIb application to continue the development of FAPXIL® towards clinical trials in FAP patients. To this end, Aim 1 will continue pharmaceutical quality and development activities; Aim 2 will establish safety, tolerability and pK of FAPXIL in non-human primates; Aim 3 will complete a Type B pre-IND meeting with the US FDA; Aim 4 will assess Investigational New Drug (IND) readiness and submit an orphan-drug designation request for FAPXIL. The Aims proposed above will enable Therapyx, Inc. to continue pre-clinical work required to obtain IND approval for this first-in-class oral biologic. Subsequent production of clinical grade drug product and IND submission will be supported via NIH's SBIR Commercialization Readiness Program and Company funds.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).