-Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (BsADC).

The designation was granted for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. There are no approved antibody-drug conjugates for patients previously treated with enfortumab vedotin.

“Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development.”

AVZO-103 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
• More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
• Rolling Review of a Biologic License Application or New Drug Application by the FDA