Pyxis Oncology Will Present New Preclinical Data Supporting Development Of First-In-Concept Antibody-Drug Conjugate Targeting EDB+FN In Tumor Microenvironment At AACR 2025

Pyxis Oncology, Inc. (NASDAQ:PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, announced today that the Company will present new, positive preclinical data highlighting the potential of micvotabart pelidotin (MICVO, formerly referred to as PYX-201), a first-in-concept antibody-drug conjugate (ADC) that targets EDB+FN, a non-cellular structural component of the tumor extra-cellular matrix. These data will be presented in two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, held from April 25 to 30, 2025.

"We are thrilled to present new preclinical data at AACR25 that further elucidate the innovative mechanism of action of MICVO, our first-in-concept EDB+FN targeting ADC, which leverages a unique non-cellular mechanism to drive anti-tumor activity," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "As we advance MICVO both as a monotherapy and in combination with anti-PD-1 therapy in the clinic, we remain confident in our multi-pronged development strategy in recurrent and metastatic head and neck squamous cell carcinoma where we believe altering the extra-cellular matrix may effectively address a main cause of resistance to other therapies."

In a previous Phase 1 dose escalation study, it was established that MICVO has profound monotherapy effect on multiple tumor types with significant tumor regression. The Company has initiated the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial to evaluate MICVO in 2L and 3L recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients who have received prior platinum and PD-1 inhibitor therapy, and 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy.

Preliminary data from patients who have received prior platinum and PD-1 inhibitor therapy are expected in the second half of 2025 and preliminary data from patients who have received prior EGFRi and PD-1 inhibitor therapy are expected in the first half of 2026. Additionally, the Company initiated a Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors, with the goal of identifying the recommended Phase 2 dose by mid-year 2025 and a readout of preliminary data in the second half of 2025.