Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data

Core Insights - Pyxis Oncology's lead drug candidate, PYX-201, has shown promising preliminary data with a confirmed 50% objective response rate (ORR) in heavily pretreated head and neck squamous cell carcinoma (HNSCC) patients, including one complete response and a 100% disease control rate in a small cohort [1][3] - The overall ORR across six solid tumor types of interest is 26%, indicating dose-dependent responses and supporting the first-in-concept mechanism of the novel extracellular targeting antibody-drug conjugate (ADC) [1][2] - A new clinical trial collaboration agreement with Merck will evaluate the combination of PYX-201 and Merck's anti-PD-1 therapy, KEYTRUDA®, in various cancer types, with dosing expected to begin in the first quarter of 2025 [1][5] Clinical Trial Details - The ongoing Phase 1 clinical trial has enrolled 80 patients across multiple solid tumor types, with doses ranging from 0.3 mg/kg to 8.0 mg/kg, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy [2][4] - The identified dose range for PYX-201 is currently between 3.6 mg/kg and 5.4 mg/kg, with a median of four prior lines of cancer therapies for enrolled patients [2][4] Safety and Pharmacokinetics - PYX-201 has demonstrated a favorable safety profile, with a low incidence of treatment-related adverse events (TRAE) and minimal Grade 3 or Grade 4 TRAEs, indicating its potential for both monotherapy and combination therapy [11][12] - The drug's design allows for increased stability in circulation, attributed to its proprietary site-specific conjugation chemistry [12] Future Development Plans - The company plans to initiate expansion studies for PYX-201 in HNSCC and other solid tumors, with preliminary clinical data expected in the second half of 2025 and early 2026 [7][9][10] - Additional exploratory cohorts are planned for ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma [9][10] Investor Engagement - Pyxis Oncology will host an investor event to discuss the preliminary Phase 1 data, featuring insights from key physician thought leaders [15][16]