FDA fast tracks investigational bispecific therapy for aggressive lung cancer
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The FDA granted fast track designation to PT217, a novel bispecific antibody, for the treatment of adults with extensive-stage small cell lung cancer, according to a release from the manufacturer.
The designation applies to individuals who experience disease progression after platinum-based chemotherapy, regardless of whether they received previous treatment with an immune checkpoint inhibitor.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
PT217 (Phanes Therapeutics) is a first-in-class bispecific antibody that targets the proteins delta-like ligand 3 (DLL3) and CD47. The investigational agent previously received orphan drug designation by the FDA for treatment of small cell lung cancer and is also being evaluated in adults with large-cell neuroendocrine carcinoma of the lung and extrapulmonary neuroendocrine carcinomas.
“PT217 has the potential to be a transformative treatment option for patients with small cell lung cancer, large-cell neuroendocrine carcinoma and extrapulmonary neuroendocrine carcinomas in various settings,” Ming Wang, PhD, MBA, founder and CEO of Phanes Therapeutics, said in a company-issued press release. “We believe the optimized anti-CD47 bispecific antibody approach can unlock the full potential of the innate immunity in targeting solid tumors.”
The phase 1 SKYBRIDGE trial is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in adults with advanced or treatment-refractory malignancies that express DLL3.
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