FDA Grants Fast Track to Pyxis Oncology's PYX-201 for Head and Neck Cancer

BOSTON, Feb. 26, 2025 – Pyxis Oncology, Inc., a clinical-stage company listed on Nasdaq under the symbol PYXS, has achieved a significant advancement in its efforts to treat hard-to-manage cancers. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its innovative drug, PYX-201. This drug is intended for adult patients suffering from recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.

PYX-201 is a pioneering antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), an integral part of the tumor extracellular matrix. This element is prominently expressed in various types of tumors. The Fast Track Designation underscores the drug's potential to meet urgent medical needs in treating R/M HNSCC, thereby speeding up its development and review process. The company is actively enrolling patients for clinical trials to advance PYX-201.

Lara S. Sullivan, M.D., the President and CEO of Pyxis Oncology, commented on this achievement, emphasizing the critical medical need in addressing R/M HNSCC and the potential impact of PYX-201. She expressed her eagerness to collaborate with the FDA to expedite the drug's development efficiently.

The Fast Track program by the FDA is designed to facilitate the development and review of new drugs that treat serious or life-threatening conditions, with a focus on addressing unmet medical needs. To qualify for this program, a drug must show promising preliminary data indicating its potential effectiveness.

Head and Neck Squamous Cell Carcinoma (HNSCC) is notably the sixth most prevalent cancer worldwide, with a significant number of new cases and deaths each year. Squamous Cell Carcinoma, originating from the mucosal linings of the oral cavity, pharynx, and larynx, is its most common type. Nearly half of these cases advance to recurrent or metastatic cancer following initial treatment, with a median survival of less than a year. By 2030, incidences of HNSCC are projected to increase by 30% annually, attributed to factors such as tobacco use, alcohol consumption, rising HPV infections, and environmental influences. Despite advances in immunotherapy, HNSCC remains challenging to treat, highlighting an urgent need for innovative therapies.

PYX-201 stands as Pyxis Oncology's leading clinical candidate, designed to inhibit microtubules with an optimized auristatin payload. It is being evaluated in two clinical trials. The first trial, PYX-201-101, assesses PYX-201 as a standalone treatment for patients with R/M HNSCC. The second, PYX-201-102, tests PYX-201 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for R/M HNSCC and other advanced solid tumors. This combination trial forms part of a collaboration with Merck, known as MSD outside the US and Canada.

Pyxis Oncology remains committed to developing next-generation therapeutics for tough-to-treat cancers. PYX-201 is being tested in Phase 1 clinical trials across multiple solid tumor types. The drug is engineered to directly target and kill cancer cells while also modifying the tumor microenvironment that allows malignant cells to proliferate unimpeded and evade immune responses.

Pyxis Oncology, Inc. continues to forge ahead in its mission to bring forward novel treatments that could potentially transform cancer therapy landscapes.