Teneobio Announces US FDA Approval of the Investigational New Drug Application for TNB-383B and the Initiation of Phase I Clinical Studies in Multiple Myeloma Patients

On April 29, 2019 Teneobio, Inc. and its affiliate TeneoOne, Inc. reported that their investigational new drug application (IND) for TNB-383B, a bispecific T-cell engaging antibody for the treatment of multiple myeloma, was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on April 24th, 2019 (Press release, TeneoBio, APR 29, 2019, View Source [SID1234535622]). The ongoing development of TNB-383B is being pursued in collaboration with AbbVie, Inc.

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TNB-383B is a fully human bispecific antibody with two binding moieties for B-Cell Maturation Antigen (BCMA) on one arm and a unique anti-CD3 on the other. In preclinical studies, TNB-383B induced T-cell dependent killing of myeloma cells (which express BCMA) but with reduced cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Roland Buelow, CEO of Teneobio, Inc. added "We are looking forward to starting clinical studies with TNB-383B. We believe that Teneobio’s differentiated anti-BCMAxCD3 (TNB-383B), which incorporates a unique T-cell activation anti-CD3, will provide a better therapeutic window for the treatment of multiple myeloma than current BCMA-targeting bispecific antibodies in the clinic. Our T-cell redirecting anti-CD3 platform is also the foundation for additional therapeutics that we are rapidly advancing in our pipeline. These include TNB-486 (anti-CD19xCD3) and TNB-585 (anti-PSMAxCD3) for the treatments of lymphoma and prostate cancer, respectively. We look forward to filing INDs on these additional programs in H2 of 2020."