On November 6, 2019 Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies for the treatment of cancer reported that it has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma (Press release, TeneoBio, NOV 6, 2019, View Source [SID1234550555]).

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"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.