Orphan drug designation granted to CC-99712 for the treatment of RRMM

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CC-99712, an antibody-drug conjugate for adult patients with relapsed/refractory multiple myeloma (RRMM).¹ CC‑99712 is composed of a B-cell maturation antigen‑targeted antibody linked to a dibenzocyclooctyne non-cleavable linker maytansinoid moiety.²

A phase I study (NCT04036461) of CC-99712 is currently underway in patients with RRMM who are aged ≥ 18 years. The phase Ia portion will evaluate the safety and tolerability of escalating doses of the agent with the aim to identify the maximum tolerated dose and non-tolerated dose, while the phase Ib section will determine the recommended dose for a phase II study. This trial is looking to enroll 120 patients.

CC-99712 is produced using a cell-free protein synthesis platform. This technology allows non-natural amino acids to be incorporated and allows conjugation to one or more chemicals of interest in a site-specific manner.