Teneobio Announces FDA Clearance of IND for TNB-585 and Initiation of Phase I Clinical Studies for Metastatic Castrate Resistant Prostate Cancer

NEWARK, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) — Teneobio, Inc. and its affiliate TeneoThree, Inc. announced today that their investigational new drug application (IND) for TNB-585, a bispecific T-cell engaging antibody for the treatment of metastatic castrate resistant prostate cancer (mCRPC) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on January 23, 2021.

Therapeutic options for mCRPC are limited, and those that are available improve survival for only up to five months. Recent clinical efforts leveraging T-cell redirection via Chimeric Antigen Receptor T-Cells and bispecific antibodies are promising, albeit complicated by frequent and occasionally severe cytokine release syndrome in treated patients. Teneobio has developed a unique anti-CD3 redirection platform that enables potent killing of cancer cells with minimal cytokine release.

Suhasini Iyer, CDO of Teneobio said, “As shown at the recent American Society of Hematology meeting (2020), the phase I data on TNB-383B, our anti-BCMAxCD3 bispecific, validated our hypothesis that uncoupling cytotoxicity from cytokine release was clinically feasible in treating multiple myeloma. We are excited to bring this unique CD3 redirecting platform profile to bear on mCRPC via TNB-585. An improved safety profile in T-cell redirection for mCRPC may enable future more efficacious combination treatments with standard-of-care therapies. Moreover, TNB-585 has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule.”

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 ArsenalBio. For more information, please visit www.teneobio.com.

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