Home / Top News / Teneobio Announces US FDA Clearance of Investigational New Drug Application for TNB-486 and the Initiation of Phase I Clinical Studies in Patients with B-cell Malignancies

Teneobio Announces US FDA Clearance of Investigational New Drug Application for TNB-486 and the Initiation of Phase I Clinical Studies in Patients with B-cell Malignancies

NEWARK, Calif., Oct. 01, 2020 (GLOBE NEWSWIRE) — 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.

Teneobio partners include AbbVie, Janssen, GSK, Kite, Poseida and Intellia. For more information, please visit www.teneobio.com.

Company Inquiries for Teneobio, Inc.
Omid Vafa, Chief Business Officer
[email protected]

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