The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC).

This marks the second Fast Track Designation for PT217, with the first having been granted for extensive-stage small cell lung cancer (ES-SCLC) earlier this year.
PT217 is a first-in-class native IgG-like bispecific antibody (bsAb)that targets DLL3 and CD47. It is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma, including NEPC. The drug’s dual targeting mechanism is a key feature in its therapeutic approach. In addition to the Fast Track designations, PT217 has also been granted orphan drug designations for the treatment of small cell lung cancer and neuroendocrine carcinoma.

The multi-center Phase I/II clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of PT217 is also ongoing in China (CTR20242720). Furthermore,  Phanes Therapeutics, the company developing PT217, has entered into a clinical supply agreement to study PT217 in combination with anti-PD-L1 therapy, atezolizumab.

The recent Fast Track designation for NEPC further underscores the potential of PT217 as a promising therapeutic option for patients with these aggressive forms of cancer.

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