Teneobio, Inc. and its affiliate TeneoThree, Inc. announced today that their investigational new drug application (IND) for TNB-585, a bispecific T-cell engaging antibody for the treatment of metastatic castrate resistant prostate cancer (mCRPC) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on January 23, 2021.
Therapeutic options for mCRPC are limited, and those that are available improve survival for only up to five months. Recent clinical efforts leveraging T-cell redirection via Chimeric Antigen Receptor T-Cells and bispecific antibodies are promising, albeit complicated by frequent and occasionally severe cytokine release syndrome in treated patients. Teneobio has developed a unique anti-CD3 redirection platform that enables potent killing of cancer cells with minimal cytokine release.
Suhasini Iyer, CDO of Teneobio said, “As shown at the recent American Society of Hematology meeting (2020), the phase I data on TNB-383B, our anti-BCMAxCD3 bispecific, validated our hypothesis that uncoupling cytotoxicity from cytokine release was clinically feasible in treating multiple myeloma. We are excited to bring this unique CD3 redirecting platform profile to bear on mCRPC via TNB-585. An improved safety profile in T-cell redirection for mCRPC may enable future more efficacious combination treatments with standard-of-care therapies. Moreover, TNB-585 has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule.”