Teneobio’s Lead Candidate, TNB-383B, Receives Orphan Drug Designation from the FDA for the Treatment of Multiple Myeloma
NEWARK, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies for the treatment of cancer announced today that it has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
“New and better treatment options are needed for multiple myeloma. While there are a number of BCMA-targeting agents currently in clinical development, TNB-383B, an anti-BCMAxCD3 currently in Phase I, is a bispecific comprised of a unique T-cell engager designed to maximize the therapeutic window for this class of drugs,” said Roland Buelow, CEO of Teneobio.
The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.
About Teneobio, Inc. Teneobio, Inc. is a clinical stage 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.
Teneobio partners include AbbVie, Janssen, GSK and Poseida. For more information, please visit www.teneobio.com.
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