The US Food and Drug Administration (FDA) has granted fast track designation to Pyxis Oncology’s antibody-drug conjugate (ADC), PYX-201, to treat adults with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
The treatment is intended for individuals whose disease progressed after treatment with platinum-based chemotherapy and an anti-programmed cell death ligand (PD-L) antibody.
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PYX-201 targets the non-cellular structural component Extradomain-B Fibronectin (EDB+FN) within the tumour extracellular matrix.
Two clinical trials involving the ADC are currently recruiting subjects. The first trial, PYX-201-101, is assessing the ADC as a single agent in subjects with the condition.
The second, PYX-201-102, is investigating the ADC plus MSD’s Keytruda (pembrolizumab), in subjects with R/M HNSCC as well as other advanced solid tumours. This trial is part of a clinical trial partnership agreement with biopharmaceutical company MSD.
Pyxis oncology president and CEO Lara Sullivan stated: “Receiving fast track designation for PYX-201 from the FDA marks a significant milestone for Pyxis oncology, recognising our potential to address the significant medical need in R/M HNSCC.
“This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we recruit patients for our trial. We look forward to working with the FDA to advance this promising therapy as efficiently as possible.”
The designation is contingent upon data showing the drug’s potential to meet an unmet medical need for the targeted condition.
Originating from the oral cavity’s mucosal lining, squamous cell carcinoma is the subtype of head and neck cancer.
In May 2023, Pyxis entered a definitive agreement to buy Apexigen in a $16m deal.
