The FDA has given fast track status to Pyxis’ drug candidate, PYX-201. This means that the review and approval process for this drug will be accelerated because it shows promise in treating a serious condition. This kind of designation is often granted to drugs that could potentially fulfill an unmet medical need. While the specific condition PYX-201 aims to treat wasn’t mentioned, similar fast-tracked drugs in the past have included names like Keytruda for cancer and Trikafta for cystic fibrosis.

Two clinical trials are currently looking for participants to test a new cancer treatment called PYX-201. This treatment, developed by Pyxis Oncology, has received fast track approval from the US Food and Drug Administration (FDA). This means the FDA recognizes its potential to address a significant medical need and will help speed up its development.

PYX-201 is designed for adults with a specific type of head and neck cancer that has returned or spread after previous treatments. These previous treatments include platinum-based chemotherapy and a type of drug known as a PD-L antibody. PYX-201 works by targeting a specific protein in the tumor’s structure called Extradomain-B Fibronectin.

There are two trials underway:

1. PYX-201-101 is testing the treatment on its own in patients with this type of cancer.
2. PYX-201-102 is testing the treatment in combination with another drug called Keytruda (pembrolizumab) in patients with head and neck cancer and other advanced cancers. This trial is part of a collaboration with the pharmaceutical company MSD.

Lara Sullivan, the president and CEO of Pyxis Oncology, stated that the FDA’s fast track designation is an important step for the company. It acknowledges their potential to meet a significant medical need and will help them bring this treatment to patients more quickly.

In May 2023, Pyxis Oncology also agreed to buy another company, Apexigen, for $16 million.