Newark, CA (Press Release) – 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.

Source: Teneobio.