California-based clinical stage biotech company Phanes Therapeutics, Inc. (Phanes) announced on Friday that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its PT217, intended for the treatment of neuroendocrine carcinoma (NEC).
PT217, a first-in-class bispecific antibody, targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) and is being developed for patients with NEC. It received ODD for the treatment of small cell lung cancer (SCLC) from the FDA in 2022, and was granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.
Earlier this year, Phanes signed a clinical supply agreement with Roche to study PT217 along with Roche's anti-PD-L1 therapy, atezolizumab.
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