Phanes Therapeutics Inc, a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced on Monday 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).
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).
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-centre Phase I/II clinical trial of peluntamig, known as the SKYBRIDGE study, is 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, and a Phase II clinical trial has been approved in China.
Adcentrx's ADRX-0706 granted US FDA Fast Track designation to treat advanced cervical cancer
AstraZeneca secures EU approval for Calquence combo as first-line treatment in mantle cell lymphoma
Phanes Therapeutics doses first patient in peluntamig-atezolizumab combination clinical study
Otsuka's leukaemia drug ponatinib launched on Fangzhou platform
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
TransCode Therapeutics reports progress in metastatic cancer trial
Ingenium Therapeutics' Gengleucel to enter Phase 2 trial in MRD+ AML following FDA feedback
AllyGPO and BioCareSD advance community oncology through integrated, tech-driven drug management
Nuformix receives positive EMA opinion for orphan drug designation of NXP002 in IPF
Atossa Therapeutics secures new US patent for proprietary (Z)-endoxifen formulations
Myosin Therapeutics receives grant to advance MT-110 clinical trial in methamphetamine use disorder
Bayer launches Phase I trial of targeted alpha therapy for advanced liver cancer