Core Insights - Pyxis Oncology, Inc. is advancing micvotabart pelidotin (MICVO), an antibody-drug conjugate (ADC) targeting EDB+FN, into clinical trials for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][6] - Preliminary data from ongoing clinical trials are expected in the second half of 2025 and the first half of 2026, focusing on patients who have previously received platinum and PD-1 inhibitor therapy [3][4] Company Developments - The company has initiated Part 2 of the Phase 1 clinical trial to evaluate MICVO in patients with R/M HNSCC who have received prior treatments [2][6] - A Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA®, has been launched, with preliminary data expected in the second half of 2025 [3][4] Mechanism of Action - MICVO utilizes a unique non-cellular mechanism to drive anti-tumor activity, potentially addressing resistance to other therapies by altering the tumor extracellular matrix [2][6] - The combination of MICVO and a mouse analog of anti-PD-1 therapy has shown significantly greater tumor regression compared to either treatment alone [1][5] Regulatory Status - MICVO has received Fast Track Designation from the U.S. FDA for treating adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [4][6] Upcoming Presentations - New preclinical data will be presented at the AACR Annual Meeting in April 2025, highlighting the potential of MICVO and its mechanism of action [1][2]
Pyxis Oncology to Present New Preclinical Data Supporting Development of First-In-Concept ADC Targeting EDB+FN in Tumor Microenvironment at AACR 2025