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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

Published: Apr 29, 2019 8:00 am
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, CA (Press Release) – 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.

Source: Teneobio.

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