Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced that the first patient has been dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy.

Peluntamig (PT217), a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC), including neuroendocrine prostate cancer (NEPC). Peluntamig (PT217) was granted two orphan drug designations (ODD) for the treatment of SCLC and NEC, respectively, by the US Food and Drug Administration (FDA). It was also granted two Fast Track designations for extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor, and metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC), respectively, by the agency. Last year, Phanes entered into a clinical supply agreement with Roche to study peluntamig (PT217) in combination with Roche's anti-PD-L1 therapy, atezolizumab.

The multi-center Phase I/II clinical trial of peluntamig (PT217) (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of peluntamig (PT217) in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of peluntamig (PT217) is also ongoing in China (CTR20242720).