Two clinical trials are currently looking for participants to test a new treatment. The US Food and Drug Administration (FDA) has given a special “fast track” status to a drug called PYX-201, developed by Pyxis Oncology, to speed up its approval process. This drug is meant for adults with a type of cancer called recurrent or metastatic head and neck squamous cell carcinoma, especially for those whose cancer worsened after using standard chemotherapy and certain antibodies.
PYX-201 works by targeting a specific part of the tumor structure called Extradomain-B Fibronectin. In one trial, PYX-201 is being tested alone, while in another, it’s being combined with another drug called Keytruda. This second trial is being conducted in partnership with a company called MSD.
The CEO of Pyxis Oncology, Lara Sullivan, said that the fast track status is an important step forward. It shows the drug’s potential to meet the treatment needs for this type of cancer and allows the company to work more closely with the FDA to develop the drug efficiently.
This type of cancer starts in the lining of the mouth. In May 2023, Pyxis also agreed to buy another company, Apexigen, for $16 million.
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(Note: Some drug names mentioned are PYX-201 and Keytruda.)