PT217 is a novel bispecific antibody (bsAb) designed to block both DLL3 and CD47, two pathways important in cancer growth and immune evasion. Developed by Phanes Therapeutics, it is aimed at aggressive malignancies such as small cell lung cancer (SCLC) and neuroendocrine prostate cancer (NEPC). The FDA has granted PT217 its second Fast Track designation, specifically for NEPC, underscoring an urgent need for new treatments in this field.
This recognition follows an earlier Fast Track designation for extensive-stage SCLC. The drug also holds orphan designations for both SCLC and neuroendocrine carcinoma. Currently, PT217 is under investigation in the SKYBRIDGE study (Phase I/II) in the US and a separate Phase I trial in China. Researchers are measuring safety, tolerability, and initial effectiveness in advanced or refractory cancers that express DLL3. Phanes Therapeutics has additionally entered a supply agreement to evaluate PT217 in combination with the anti-PD-L1 medication atezolizumab.
The FDA’s latest decision highlights PT217’s promise as a novel therapy for patients facing difficult-to-treat forms of prostate cancer.
Blue Sky News - Prostate Cancer Foundation of Australia - April 2023
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer 