Date: 05-Oct-2020

Teneobio Announces US FDA Clearance Of Investigational New Drug Application For TNB-486 And The Initiation Of Phase I Clinical Studies In Patients Wit

Teneobio, Inc. and its affiliate TeneoTwo, Inc. announced today that their investigational new drug application (IND) for TNB-486, a bispecific T-cell engaging antibody for the treatment of B-Cell Non-Hodgkin’s lymphoma (B-NHL) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on September 30, 2020.

TNB-486 is a fully human bispecific antibody that binds CD19 with one arm and incorporates a unique anti-CD3 on the other. In preclinical studies, TNB-486 induced T-cell dependent killing of CD19-positive B-cell leukemia and lymphoma cells while inducing minimal cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Benjamin Buelow, CMO of Teneobio, Inc., added, “We are excited to bring our differentiated T-cell engager therapy to relapsed and/or refractory lymphoma patients, for whom a safe and effective therapeutic option remains an unmet need. The unique anti-CD3 arm in Teneobio’s T-cell engagers uncouples toxic cytokine release from tumor cell killing and is designed to maximize the therapeutic window for this class of therapies. TNB-486 also has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule. An off-the-shelf CD19-targeted therapy with a convenient dosing regimen will be a tremendous boon to the fight against this terrible disease.”

About Teneobio, Inc.
Teneobio, Inc. is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb®), 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 (UniDab®) derived from UniAb® 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.