Pyxis Oncology(US:PYXS) Globenewswire·2025-12-18 12:00Core Insights - Pyxis Oncology announced positive preliminary data from Phase 1 clinical studies of micvotabart pelidotin (MICVO), an antibody-drug conjugate targeting extradomain-B of fibronectin, in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][2] Monotherapy Findings - In the Phase 1 monotherapy study, MICVO demonstrated a 46% confirmed objective response rate (ORR) and a 92% disease control rate (DCR) at a dose of 5.4 mg/kg in 2L+ R/M HNSCC [4] - The study included 18 patients, all of whom had prior systemic therapy, with a median of 3 prior lines of therapy [5] Combination Therapy Findings - In the Phase 1/2 study combining MICVO with pembrolizumab, the confirmed ORR was 71% and the DCR was 100% at doses of 3.6 mg/kg and 4.4 mg/kg [4][8] - The combination therapy included patients with varying PD(L)-1 CPS scores, and responses were observed even in those who had previously progressed on checkpoint inhibitors [8] Future Developments - Updated data from the ongoing Phase 1 monotherapy study is expected in mid-2026, while updated data from the combination study is anticipated in the second half of 2026 [9] - The company has received FDA alignment on the clinical trial design for a pivotal monotherapy study in 2L+ R/M HNSCC and is evaluating the path forward for pivotal studies [10] Financial Update - Pyxis Oncology completed the sale of rights to royalties from the commercialization of Enzeshu for a one-time cash payment of $11 million, which will support the development of MICVO [11]