Phanes Therapeutics Receives CDE Approval to Initiate Phase 2 Combination Trial of First-in-Class DLL3/CD47 Bispecific Antibody Peluntamig (PT217) in Small Cell Lung Cancer and Neuroendocrine Carcinomas

▎PharmaEngine Content Team Report

Peluntamig is a potential "first-in-class" bispecific antibody with a natural IgG structure, targeting DLL3 and CD47.DLL3The full Chinese name is delta-like canonical Notch ligand 3, which is expressed on the surface of tumor cells in approximately 85% of patients with small cell lung cancer and large cell neuroendocrine carcinoma.CD47It is a transmembrane protein expressed on tumor cells. Blocking the CD47-SIRPα interaction can promote the phagocytosis of tumor cells by macrophages.According toPhanes TherapeuticsIntroduction to Public Information，PT217It can directly kill tumor cells through the ADCC activity of NK cells and the ADCP activity of macrophages, and expand the scope of tumor killing by simultaneously targeting the overexpressed DLL3 and CD47 on the surface of tumor cells.

Peluntamig has previously been granted two orphan drug designations by the U.S. FDA, respectively for the treatment ofSmall Cell Lung Cancer and Neuroendocrine Carcinoma`, it has also received two Fast Track designations granted by the FDA, one for the treatment of patients with disease progression following platinum-based chemotherapy.`Extensive-Stage Small Cell Lung Cancer (ES-SCLC)Patients, regardless of whether they have received combination therapy with immune checkpoint inhibitors, another treatment for primary and treatment-inducedProstate Neuroendocrine Carcinoma (NEPC)。

According toPhanes Therapeutics' press release introduced that the multi-center Phase 1/2 clinical trial of peluntamig in the United States, namely the SKYBRIDGE study, is currently evaluating peluntamig inPatients with advanced or refractory cancers expressing DLL3Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in China.

The product was approved in 2024 to conduct a Phase 1 clinical trial in China. This approval for a Phase 2 clinical trial in China, to be conducted in combination with chemotherapy and/or PD-L1 inhibitors, will further advance the clinical development of peluntamig in China, with the hope of bringing new treatment options to patients with small cell lung cancer and other neuroendocrine cancers.

References:

[1]Phanes Therapeutics' bispecific antibody peluntamig (PT217) Phase II combination therapy clinical trial application approved by CDE.Retrieved Apr 7，2025, From https://mp.weixin.qq.com/s/1QIe0YRtJAkH2n_6BqQzUQ