First Patient Dosed in Peluntamig Combination Therapy Trial for Small Cell Lung Cancer
核心洞察
Phanes Therapeutics (搜索) has initiated dosing in a clinical trial evaluating peluntamig (PT217), a first-in-class bispecific antibody targeting DLL3 (搜索) and CD47 (搜索), in combination with chemotherapy for small cell lung cancer (搜索) and neuroendocrine carcinoma (搜索).
The drug has received multiple FDA designations, including Orphan Drug Designation for SCLC and NEC, and Fast Track status for extensive-stage SCLC and metastatic neuroendocrine prostate cancer (搜索).
The SKYBRIDGE study, a multi-center Phase I/II trial, will assess peluntamig's safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced DLL3 (搜索)-expressing cancers.
Phanes Therapeutics (搜索) has announced the initiation of patient dosing in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy, marking a significant milestone in the development of novel treatments for aggressive neuroendocrine cancers.
Novel Dual-Targeting Approach
Peluntamig represents a pioneering approach in oncology as a first-in-class native IgG-like bispecific antibody that simultaneously targets DLL3 (搜索) and CD47 (搜索). This innovative therapy is being developed specifically for patients with small cell lung cancer (搜索) (SCLC) and neuroendocrine carcinoma (搜索) (NEC), including neuroendocrine prostate cancer (搜索) (NEPC).
Regulatory Support and Strategic Collaborations
The therapeutic potential of peluntamig has been recognized by multiple regulatory designations from the FDA, including:
- Orphan Drug Designations for both SCLC and NEC treatment
- Fast Track Designations for extensive-stage SCLC with disease progression following platinum chemotherapy
- Fast Track status for metastatic de novo or treatment-emergent neuroendocrine prostate cancer
In a strategic move to expand treatment options, Phanes has established a clinical supply agreement with Roche to investigate peluntamig in combination with atezolizumab, Roche's anti-PD-L1 (搜索) therapy.
Clinical Trial Details
The SKYBRIDGE study (NCT05652686), a multi-center Phase I/II clinical trial, is now underway to evaluate:
- Safety and tolerability profiles
- Pharmacokinetic properties
- Preliminary efficacy in patients with advanced or refractory cancers expressing DLL3
A parallel Phase I clinical trial is also progressing in China (CTR20242720), demonstrating the global scope of peluntamig's development program.
Comprehensive Development Pipeline
This trial adds to Phanes Therapeutics (搜索)' growing oncology portfolio, which includes three ongoing Phase I/II clinical trials:
- The MORNINGSTAR study with mavrostobart (PT199), a best-in-class monoclonal antibody
- The TWINPEAK study investigating spevatamig (PT886)
- The SKYBRIDGE study with peluntamig (PT217)
The company's development efforts are supported by its proprietary technology platforms: PACbody®, SPECpair®, and ATACCbody®, which enable the creation of novel biologics targeting significant unmet needs in cancer treatment.