Pyxis Oncology Receives FDA Fast Track Designation for PYX-201 in Head and Neck Cancer Treatment
Thursday, February 27, 2025
Pyxis Oncology, Inc a clinical-stage company developing advanced cancer therapies, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for PYX-201. This designation applies to the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed after receiving platinum-based chemotherapy and an anti-PD-(L)1 antibody.
PYX-201 is an antibody-drug conjugate (ADC) designed to target Extradomain-B Fibronectin (EDB+FN), a structural component of the tumour extracellular matrix that is highly expressed in several cancer types. The Fast Track designation aims to speed up the development and review of drugs intended to treat serious conditions with limited treatment options.
Head and neck cancer is the sixth most common cancer globally, with nearly 1.5 million new cases and close to 500,000 deaths recorded each year. Squamous cell carcinoma is the most prevalent form, originating from the mucosal lining of the oral cavity, pharynx, and larynx. Almost half of these cases progress to recurrent or metastatic stages, where the median overall survival is less than a year. The incidence of HNSCC is expected to rise significantly by 2030, influenced by factors such as tobacco use, alcohol consumption, increasing HPV infections, and environmental triggers. Despite recent advancements in immunotherapy, treatment options remain limited, highlighting the need for new therapeutic approaches.
PYX-201 is the lead clinical candidate for Pyxis Oncology and carries an optimised auristatin payload, which functions as a microtubule inhibitor. Two clinical trials for PYX-201 are currently underway. The first, PYX-201-101, is assessing PYX-201 as a monotherapy for patients with R/M HNSCC. The second, PYX-201-102, is evaluating its use in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with R/M HNSCC and other advanced solid tumours. This combination trial is part of a Clinical Trial Collaboration Agreement between Pyxis Oncology and Merck (known as MSD outside the US and Canada).
Source: pyxisoncology.com
