On May 5, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of peluntamig in combination with Roche’s anti-PD-L1 monoclonal antibody atezolizumab (TECENTRIQ ) (Press release, Phanes Therapeutics, MAY 5, 2025, View Source [SID1234652526]). The study is being conducted in a cohort of patients with extensive-stage small cell lung cancer (ES-SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinomas (EP-NECs).
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As previously announced, Phanes is conducting this study under a clinical supply agreement with Roche. Peluntamig is Phanes’ first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47. It was granted two orphan drug designations by the FDA for the treatment of SCLC and NEC, respectively, and two Fast Track designations for 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.
The multi-center Phase I/II clinical trial of peluntamig (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of peluntamig in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of peluntamig is also ongoing in China (CTR20242720), and a Phase II clinical trial has been approved in China.
TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.