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

NEWARK, Calif., April 29, 2019 (GLOBE NEWSWIRE) -- Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today 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.  The ongoing development of TNB-383B is being pursued in collaboration with AbbVie, Inc.

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.”

About Teneobio, Inc.                                                                                                  
Teneobio, Inc. is a biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAbs™), for the treatments of cancer, autoimmunity, and infectious diseases. Teneobio’s discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat® and OmniFlic®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. Versatile antibody variable domains (UniDabs™) derived from UniAbs™ can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. Teneobio’s “plug-and-play” T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity. The company has received funding from institutional investors, including Lightspeed Venture Partners and Sutter Hill Ventures. For more information, visit www.teneobio.com.

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