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.
Leo Cancer Care invests in children's experience of radiotherapy, following world-first treatments
Innovent expands global Phase 3 study of IBI363/TAK-928 to include non-squamous NSCLC
FDA approves WELIREG and LENVIMA combination for previously treated advanced renal cell carcinoma
AstraZeneca's IMFINZI combination receives US Priority Review for muscle-invasive bladder cancer
UChicago Medicine completes construction phase of new cancer facility
FDA Advisory Committee votes in favour of GRAIL's Galleri multi-cancer early detection test
Astellas doses first patient in Phase 3 lung cancer study
X-Chem and Relay Therapeutics collaborate on Phase 3 milestone
BoomRay enters exclusive radioligand therapy asset global license agreement with Novartis
AbbVie and Iambic agree collaboration for discovery and development of small molecule therapies
Grunenthal to acquire Stivarga cancer treatment
Precigen announces FDA platform technology designation for AdenoVerse
Enhertu recommended for EU approval in early HER2-positive breast cancer
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS