FY2025 SBIR CONCEPT CLEARANCE AWARD FOR TOPIC DEVELOPMENT OF THERAPEUTIC OR PREVENTATIVE TECHNOLOGIES FOR TREATMENT OR PREVENTION OF PEDIATRIC CANCERS AND/OR RARE CANCERS.

Glioblastoma Multiforme (GBM) remains a highly aggressive type of brain cancer with a five-year survival rate of only 6.8% and a median patient survival of 14.6 months. A new wave of adoptive cell transfer therapeutics using T-cell receptors (TCRs) designed to mimic endogenous TCRs to target TAAs is becoming a popular alternative to CAR-T therapies. Tenaci-T Therapeutics is developing a specific, TCR-driven T cell biotherapeutic against FOXM1, a common oncogene in Glioblastoma multiforme (GBM). FOXM1 is a member of the forkhead box (FOX) family of transcription factors (TFs) not canonically expressed in terminally differentiated cells but expressed in high levels in specific cancers, including a 40-fold upregulation GBM compared to healthy brain tissue. In this Innovative Concept Award, Tenaci-T proposes characterization of FOXM1-TCR-T cell therapy as a novel therapeutic for GBM patients to prevent progression and prolong patient survival. This project proposes evaluation of FOXM1-TCR-T efficacy both in GBM cell lines and in an orthotoptic mouse model of GBM. Upon completion, Tenaci-T will have developed proof-of-concept for the FOXM1-TCR-T therapeutic to be further evaluated for GBM treatment.